I think that if future historians look back on this period, what they will see is a tragedy of denial. Everything we needed to do to have lowered the infection rate on coronavirus … we had this technology. There’s nothing fancy about face masks, right? And even ventilators — OK, they’re expensive — but … that technology existed. But we didn’t use it, or we didn’t use it as effectively as we could have because we weren’t willing to be honest about what we were facing…”
“There’s no business case for stockpiling a billion face masks. But there is a scientific and public health case. We didn’t listen to that scientific and public health case because we were so enthralled in this notion that the market would solve all our problems. And I think that’s the big thing that historians will look back on and see as this sort of colossal error that ended up being very, very costly.” (A)
“Dr. Deborah L. Birx, the Trump administration’s coronavirus coordinator, said on Sunday that the nation was in a “new phase” of the coronavirus epidemic that was much more sprawling across the country than last spring’s outbreaks in major cities like New York and Seattle.
She recommended that people living in communities where cases are surging should consider wearing a mask at home, if they live with someone who is especially vulnerable because of age or underlying medical conditions.
“What we are seeing today is different from March and April — it is extraordinarily widespread,” she said on CNN’s “State of the Union” news program. “It’s into the rural as equal urban areas. So everybody who lives in a rural area, you are not immune.”
Dr. Birx emphasized the significance of asymptomatic transmission, and said that the White House coronavirus task force was working to make sure Americans in affected communities understood this risk. “If you have an outbreak in your rural area or in your city, you need to really consider wearing a mask at home, assuming that you’re positive if you have individuals in your home with comorbidities,” like respiratory problems or diabetes…
In some communities seeing recent outbreaks, household transmission has been a huge factor, public health experts say…
Admiral Giroir defended the nation’s testing program, noting it has exponentially been increased in recent months although there are still delays in getting results. He said that both testing and contact tracing efforts were crucial responses, but not particularly helpful in large, communitywide outbreaks.
“When you have a widespread, multifocal outbreak where many people are asymptomatic, testing and tracing are of limited utility versus public health policy measures like mask-wearing, like closing indoor crowded spaces,” Admiral Giroir said. “So, yes, contact tracing is important, but it’s much less important right now than the public policy mitigation measures.”” (C)
“Speaker Nancy Pelosi (D-Calif.) on Monday doubled down on questioning the credibility of Deborah Birx, the physician coordinating the White House’s coronavirus task force, arguing that she has been “enabling” President Trump to spread disinformation about the coronavirus.
“I don’t have confidence in anyone who stands there while the president says, swallow Lysol, it’s going to cure your virus. It’ll kill you and you won’t have the virus anymore,” Pelosi said during an interview with CNN’s Jim Sciutto.
“There has to be some responsibility. So if the president is saying these things, who’s advising him that this is OK and enabling that to happen while millions of people have died?” Pelosi said.
Pelosi’s comments come as Birx also faced criticism earlier Monday from Trump, who attacked her for acknowledging that the coronavirus pandemic is “extraordinarily widespread” across the U.S.
Trump suggested that Birx was trying to “counter” Pelosi’s previous criticism…
Pelosi reiterated during an appearance on ABC’s “This Week” on Sunday that she lacked confidence in Birx, saying “I think the president is spreading — spreading disinformation about the virus and she is his — she is his appointee.”
Pelosi said Monday that Birx came up during the meeting with Mnuchin and Meadows during a discussion about contact tracing.
“What happened is that we had a conversation about how we stop the virus. And when we did, they were making contentions about how tracing isn’t a valuable thing, we shouldn’t do it. I said, well that’s not what most scientists say. And they said, well we’ll bring a scientist to say that. I said, sure, [if] it’s not Dr. Birx,” Pelosi said in the CNN interview.” (D)
Dr. Deborah Birx on Sunday strongly defended her record amid criticism from House Speaker Nancy Pelosi that she doesn’t have confidence in the White House coronavirus task force coordinator’s handling of the pandemic.
On “State of the Union,” Birx told CNN’s Dana Bash that she has “tremendous respect” for Pelosi, but criticized a New York Times article last month that reported she had painted an optimistic view of the pandemic to the White House during a critical period in getting control of the virus.
“I have tremendous respect for the speaker, and I have tremendous respect for her long dedication to the American people,” Birx said, adding, though, that she could have “brought forth the data” to back up her analysis had the Times spoken with her.
“I have never been called pollyannish, or nonscientific, or non-data driven,” Birx said. “And I will stake my 40-year career on those fundamental principles of utilizing data to really implement better programs to save more lives.”…
Asked by Bash if it was time to reset the federal government response to the pandemic, Birx said, “I think the federal government reset about five to six weeks ago when we saw this starting to happen across the South.” Roughly six weeks ago, however, Vice President Mike Pence, who heads the coronavirus task force, declared in a Wall Street Journal op-ed that the US is “winning the fight” and there “isn’t a ‘second wave.'”” (E)
President Trump on Monday publicly criticized Deborah Birx, the doctor who is coordinating the White House’s coronavirus response, suggesting she was hurting him after she bluntly acknowledged that the pandemic is widespread across the United States.
Trump targeted Birx over a weekend response to criticism from Speaker Nancy Pelosi (D-Calif.), who questioned Birx’s credibility in responding to the pandemic. He appeared to call Birx’s response to Pelosi’s criticism “pathetic.”
“So Crazy Nancy Pelosi said horrible things about Dr. Deborah Birx, going after her because she was too positive on the very good job we are doing on combatting the China Virus, including Vaccines & Therapeutics,” Trump tweeted. “In order to counter Nancy, Deborah took the bait & hit us. Pathetic!”
The tweet marks the latest instance of Trump undercutting one of his administration’s top health officials in the middle of a pandemic, but it is the first time he has publicly criticized Birx.” (F)
Dr. Anthony S. Fauci, the nation’s top infectious disease specialist, agreed on Monday with his colleague Dr. Deborah Birx that the United States has entered a “new phase” of the coronavirus pandemic, in which the virus is now spreading uncontrolled in some states by asymptomatic people — comments that drew fire from President Trump.
Dr. Fauci said Dr. Birx had been referring to the “inherent community spread” that is occurring in some states, adding: “When you have community spread, it’s much more difficult to get your arms around that and contain it.”
Speaking during a news conference with Gov. Ned Lamont of Connecticut, Dr. Fauci called the community spread “insidious” and noted that it was happening outside of confined spaces like nursing homes and prisons.
In backing up Dr. Birx, the Trump administration’s coronavirus response coordinator, Dr. Fauci indirectly put himself at odds with the president. Earlier on Monday, Mr. Trump had called Dr. Birx “pathetic” on Twitter and suggested that her comments about a “new phase” were an effort to curry favor with Speaker Nancy Pelosi.
At an evening news conference, Mr. Trump appeared to temper his comments about Dr. Birx. “She’s a person I have a lot of respect for,” he said, while defending his administration’s response to the virus…
But other Republicans piled on. “Dr. Birx, like Dr. Fauci, has been wrong much more than she has been right on COVID-19, & their destructive prescriptions have led to the devastation of countless American lives,” Representative Andy Biggs, Republican of Arizona, wrote on Twitter…
On Monday morning, shortly after Mr. Trump tweeted about her, Dr. Birx told governors on a weekly briefing call that a lack of masks at large gatherings in homes was “a critical issue,” pointing to spikes in many Southern states.
Mr. Trump has also criticized Dr. Fauci, despite his claims that the two have a “very good relationship.” In a tweet on Saturday responding to news reports that Dr. Fauci had linked the recent surge in cases to inadequate lockdowns, Mr. Trump tweeted: “Wrong!”” (G)
“I’ve gone to your rallies. I’ve talked to your people. They love you. They listen to you. They listen to every word you say. They hang on your every word,” Swan said. “And so when they hear you say, ‘everything’s under control. Don’t worry about wearing masks,’ I mean, these are people — many of them are older people.”
“Well, what’s your definition of control?” Trump replied, adding: “I think it’s under control.”
“How? A thousand Americans are dying a day,” Swan said.
“They are dying. That’s true. And you — it is what it is,” Trump said emphatically. “But that doesn’t mean we aren’t doing everything we can. It’s under control as much as you can control it.”” (H)
Dr. Anthony Fauci and Dr. Deborah Birx, two key members of the White House coronavirus task force, have warned nine major cities across the country over their high COVID-19 testing positivity rates.
Birx, coordinator of the White House task force, first raised concerns about the high positivity rates in Atlanta; Baltimore; Boston; Chicago; Detroit; Kansas City, Missouri; Portland, Oregon; Omaha, Nebraska; and Washington, D.C.; in a Wednesday call with state and local officials. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), was asked about the remarks in an interview with CNN on Thursday morning, and he explained that the test positivity rate is “a pretty good predictor” or “indicator” that surges in new infections are coming.
“So what Dr. Birx is saying is now is the time to accelerate the fundamental preventive measures that we all talk about,” Fauci explained. “Masks, social distancing, avoiding crowds, outdoors greater than indoors, washing hands, etc. Those kind of simple things can actually prevent that uptick from becoming a surge.” Fauci emphasized that the heightened positivity rate “is a predictor of trouble ahead.”
In her Wednesday remarks to local officials, Birx raised particular concerns about the situations in Atlanta and Baltimore. “We are concerned that both Baltimore and Atlanta remain at a very high level,” she said.
“This outbreak is different from the March, April outbreak in that it’s in both rural and urban areas,” she cautioned…
Increasing rates of positive COVID-19 tests within a specific area generally correlate with an increase in community spread. If community spread rises unchecked, the novel coronavirus outbreak can quickly spiral out of control leading to overwhelmed hospitals and making it difficult to curb the spread of the pandemic.” (I)
“Within public health circles, debate is raging over how much blame Dr. Birx bears for the virus’s spread. Some say Mr. Trump is responsible, but, they add, the dangerous misinformation he has spread has often gone uncorrected by Dr. Birx.
“Trump is like the reverse Midas,” said Gregg Gonsalves, a longtime AIDS activist and assistant professor of epidemiology at the Yale School of Public Health. “Everybody who is in his orbit, if they’ve had any integrity, it gets leeched away from them like some parasite.”
But some say Dr. Birx is at least partly responsible for mismanaging the government’s response. A report issued by the State Department’s inspector general in February relayed criticism of her AIDS program leadership team, which was called “dictatorial” and “autocratic.” She has been critical of the Centers for Disease Control and Prevention, and some public health experts view her as partly responsible for sidelining the agency.
Some also fault her for offering unduly rosy assessments of the pandemic — both in public and in private. In April, she told officials in the White House Situation Room that the United States was in good shape…
In interviews with AIDS activists and public health experts, Dr. Birx drew unfavorable comparisons with the outspoken Dr. Fauci, in whose lab she trained. Mr. Gonsalves, who has long known both of them, said he wrote in March to Drs. Birx, Fauci and Redfield, as well as Adm. Brett P. Giroir, who oversees coronavirus testing, complaining that they were “parroting the president.” Only Dr. Fauci replied.
“Debbie is now in the position where she’s saying to the emperor that those new clothes look fantastic,” Mr. Gonsalves said…
Dr. Birx has drawn criticism for what she has said — and what she has not said. She remained virtually silent while Mr. Trump suggested from the White House lectern that exposure to ultraviolet light or household disinfectants might cure Covid-19. Her lavish praise for the president on the Christian Broadcasting Network in March still rankles.
“He’s been so attentive to the scientific literature and the details and the data,” she said then.
Dr. Ashish Jha, the director of the Harvard Global Health Institute, who has known Dr. Birx for at least a decade and regards her as “a genuinely smart and caring person,” initially gave her the benefit of the doubt on that interview.
“A bunch of people in the public health world just lost their minds on that one, but I said, ‘Look, if she has to praise the president to get him to do the right thing, I can live with that,’” Dr. Jha said. But now, he said, “she has to ask herself whether she’s being effective in protecting the American people, and I would argue at this point that it is not clear that she is.”” (J)
White House coronavirus task force coordinator Deborah Birx is warning of an uptick in coronavirus cases in nine U.S. cities.
“Many of the Sun Belt states have made substantial progress with their mitigation efforts,” Birx told state and local officials on Wednesday, according to a copy of the call obtained the Center for Public Integrity, referring to a slew of Southern states that experienced surges earlier this summer.
But Birx said that the percentage of coronavirus tests coming back positive is increasing in nine U.S. cities as well as California’s Central Valley.
“We are concerned that both Baltimore and Atlanta remain at a very high level. Kansas City, Portland, Omaha, of course what we talked about in the Central Valley,” Birx said. “We are seeing a slow uptick in test positivity in cases in places like Chicago, Boston and Detroit and D.C.”
Birx also said that Nebraska and California have moved into the red category, with more than 10 percent of tests coming back positive. And she noted that while Los Angeles saw improvements, there was significant movement of the virus up California’s Central Valley.
Birx noted that the virus has entered a new phase, “in that it’s in both rural and urban areas.”
In another call obtained by the Center for Public Integrity last month, Birx warned of an uptick in 12 other U.S. cities, including Miami, New Orleans, Las Vegas, San Jose, St. Louis, Indianapolis, Minneapolis, Cleveland, Nashville, Pittsburgh, Columbus and Baltimore.
Thursday morning, Anthony Fauci, the nation’s leading infectious disease expert and member of the White House coronavirus task force, said that the infection rate is a “pretty good predictor” for potential surges.
“We’ve seen that in the Southern states as predictors,” Fauci said on CNN. “This is a predictor of trouble ahead.”
“You’ve got to get that base line down,” he added. “Everybody on the team of American citizens need to pull together. Because we’re all in this together.”” (K)
“But on a personal level, the attack also represented a surprisingly direct assault on one of the most recognizable scientific faces on the team of officials Trump regularly puts before the cameras to describe the White House coronavirus strategy.
She has a very difficult job right now, because she’s dealing with someone who is not evidence-based
Birx, a scientist whose signature scarves are the subject of a dedicated Instagram account, was always known to be stepping on to a political tightrope by taking her current White House role. But now former allies and critics of Birx suggest that the renowned global Aids researcher, health official, medical doctor and army colonel has sacrificed her public mission for a more personal one – staying on Trump’s good side.
Birx’s defenders forcefully rebut that contention, saying her public guidance throughout the coronavirus pandemic has been reliable. They theorize, based on their personal experiences of working with her, that her private guidance of the president and his team has steered the administration in a useful direction, even if that is not always publicly evident.
“She has a very difficult job right now, because she’s dealing with someone who is not evidence-based, and is not understanding what needs to be done to address this pandemic,” said Kenneth Mayer, a professor of medicine and global health at Harvard who worked closely with Birx for years as a member of the scientific advisory committee of the President’s Emergency Plan for Aids Relief (Pepfar). “It’s hard.”” (L)
‘To this point, Dr. Anthony Fauci during a recent Q&A session at the Brown University School of Public Health articulated that the first coronavirus vaccine might only be 60% effective, if not lower. Not one to mince words, Fauci said that the probability of a coronavirus vaccine being 98% effective is “not great.”
“You’ve got to think of the vaccine as a tool to be able to get the pandemic to no longer be a pandemic,” Fauci explained, “but to be something that’s well controlled.”
That said, Fauci said a coronavirus vaccine that is only 50% effective would still be acceptable and liable to be given the green light by the FDA…
There’s also a chance the first coronavirus vaccine may not even be able to prevent someone from being infected in the first place. Rather, it may only prevent an individual from experiencing some of the coronavirus’ more severe symptoms.
Efficacy aside, Fauci earlier this week said that the United States — in a best-case scenario — would have tens of millions of COVID-19 vaccine doses ready to go by early 2021. If that actually pans out, Fauci anticipates that life in the United States will return to normal by the middle of next year at the soonest.” (M)
(Dr. Stephen Hahn, the Commissioner of the Food and Drug Administration)
“Many medical experts — including members of his own staff — worry about whether Dr. Hahn, despite his good intentions, has the fortitude and political savvy to protect the scientific integrity of the F.D.A. from the president. Critics point to a series of worrisome responses to the coronavirus epidemic under Dr. Hahn’s leadership, most notably the emergency authorization the agency gave to the president’s favorite drug, hydroxychloroquine, a decision it reversed three months later because the treatment did not work and harmed some people.” (N)
“President Donald Trump on Wednesday maintained that the coronavirus is “going away” and continued to push for schools to reopen since the virus “doesn’t have much of an impact” on children.
Trump applauded the country’s coronavirus vaccine and therapeutic development, saying it has had “tremendous success” and is “ready to deliver them literally as soon” as they’re approved.
When it comes to the coronavirus, he said children are able to “throw it off very easily.”
“It’s going away. It’ll go away. Things go away. No question in my mind that it will go away,” Trump said during a White House press briefing…
“We think we’re going to have the vaccines before the end of the year, maybe long before the end of the year,” Trump said. “ (O)
“And on Wednesday, Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and the most senior public health official on the taskforce, said: “I don’t think we’re going to eradicate this from the planet … because it’s such a highly transmissible virus that that seems unlikely.”
And despite Trump claiming in an interview with Axios released on Monday that coronavirus is under control in the US, Fauci on Wednesday spoke of a much longer timescale to achieve that.
“I hope and feel it’s possible that by the time we get through 2021 and go around for another cycle, that we’ll have this under control … Do I think we’re going to have a much, much better control one full year from this winter? I think so,” Fauci said in an interview with Reuters.
Fauci said he was cautiously optimistic about US progress toward developing a successful and safe vaccine and achieving mass distribution next year.
“Historically, if you get a vaccine that has a moderate to high degree of efficacy, and you combine with that prudent public health measures, we can put this behind us,” he said.
He added: “We may need to go through a season of it, and then by the next season if we have a vaccine it won’t be a pandemic, it won’t be immobilizing the world, it won’t be destroying the economy.”” (P)
A senior fellow at Stanford University’s Hoover Institution, a conservative think tank, Atlas is not an infectious disease expert — he’s board-certified in diagnostic radiology, which means he specializes in reading and interpreting imaging like X-rays, CT scans and MRIs, and he served as a professor and chief of neuroradiology at Stanford University Medical Center from 1998 to 2012…
Atlas has recently appeared as a guest on Trump’s preferred news channel, Fox, calling on school districts and colleges to open their doors for in-person instruction and railing against the “frenzy” around mass testing…
“Scott is a very famous man who’s also very highly respected,” Trump said on Monday. “He’s working with us and will be working with us on the coronavirus. And he has many great ideas.”” (Q)
“Nearly three dozen current and former members of a federal health advisory committee, including nine appointed or reappointed by the health secretary, Alex M. Azar II, are warning that the Trump administration’s new coronavirus database is placing an undue burden on hospitals and will have “serious consequences on data integrity.”
The advisers, all current or former members of the Healthcare Infection Control Practices Advisory Committee, issued their warning in a previously unpublished letter shared with The New York Times.
The letter was made public as both hospital officials and independent data experts around the country were reporting kinks in the new system, which critics say is undermining the government’s ability to understand the course of the pandemic. The Covid Tracking Project, a respected and widely used resource, identified “major problems” with the new Department of Health and Human Services system in late July, and reported this week that “the federal data continue to be unreliable.”
The concern grows out of an order, issued last month by Mr. Azar, for hospitals to send daily reports about virus cases to a private vendor that transmits them to a central database in Washington instead of the Centers for Disease Control and Prevention, which had previously housed the data.
The information, including patient and hospital bed counts, helps guide the government’s response to the pandemic, informing critical health care decisions like how to allocate scarce supplies, including ventilators or the drug Remdesivir, approved as a treatment for Covid-19 patients…
“The U.S. cannot lose their decades of expertise in interpreting and analyzing crucial data,” the authors wrote, adding that the C.D.C.’s experts, from its Division of Healthcare Quality Promotion, must “be allowed to continue their important and trusted work.”” (R)
“I’m pretty much fighting two wars: A war against COVID and a war against stupidity,” Dr. Varon, MD, CMO and chief of critical care at United Memorial Medical Center in Houston, told NBC News. “And the problem is the first one, I have some hope about winning. But the second one is becoming more and more difficult.” (B)
PART 1. January 21, 2020. CORONAVIRUS. “The Centers for Disease Control and Prevention on Tuesday confirmed the first U.S. case of a deadly new coronavirus that has killed six people in China.”
PART 2. January 29, 2020. CORONAVIRUS. “If it’s not contained shortly, I think we are looking at a pandemic..”….. “With isolated cases of the dangerous new coronavirus cropping up in a number of states, public health officials say it is only a matter of time before the virus appears in New York City.”
PART3. February 3, 2020. “The Wuhan coronavirus spreading from China is now likely to become a pandemic that circles the globe…”..Trump appeared to downplay concerns about the flu-like virus …We’re gonna see what happens, but we did shut it down..” (D)
PART 4. February 9, 2020. Coronavirus. “A study published Friday in JAMA found that 41% of the first 138 patients diagnosed at one hospital in Wuhan, China, were presumed to be infected in that hospital.….
PART 5. February 12, 2020. CORONAVIRUS. “In short, shoe-leather public health and basic medical care—not miracle drugs—are generally what stop outbreaks of emerging infections..”
POST 6. February 18, 2020. Coronovirus. “Amid assurances that the (ocean liner) Westerdam was disease free, hundreds of people disembarked in Cambodia…” “ One was later found to be infected”…. “Over 1,000… passengers were in…transit home”…. “This could be a turning point””
PART 7. February 20, 2020. CORONAVIRUS. With SARS preparedness underway in NJ LibertyHealth/ Jersey City Medical Center, where I was President, proposed that our 100 bed community hospital with all single-bedded rooms, be immediately transformed into an EMERGENCY SARS ISOLATION Hospital.
PART 8. February 24, 2020. CORONAVIRUS. “…every country’s top priority should be to protect its health care workers. This is partly to ensure that hospitals themselves do not become sites where the coronavirus is spread more than it is contained.”
PART 9. February 27, 2020. CORONAVIRUS. Responding to a question about the likelihood of a U.S. outbreak, President Trump said, “I don’t think it’s inevitable…”It probably will. It possibly will,” he continued. “It could be at a very small level, or it could be at a larger level.”
Part 10. March 1, 2020. CORONAVIRUS. Stop Surprise Medical Bills for Coronavirus care. (&) Lessons Learned (or not) In California and Washington State from community acquired cases.
PART 11. March 5, 2020. CORONAVIRUS. “Gov. Andrew Cuomo… would require employers to pay workers and protect their jobs if they are quarantined because of the coronavirus.”
Part 12. March 10, 2020. CORONAVIRUS. “Tom Bossert, Donald Trump’s former homeland security advisor…(said) that due to the coronavirus outbreak, “We are 10 days from the hospitals getting creamed.”
Part 13.. March 14, 2020. CORONAVIRUS. “If I’m buying real estate in New York, I’ll listen to the President….If I’m asking about infectious diseases, I’m going to listen to Tony Fauci,”
PART 14. March 17, 2020. CORONAVIRUS. “ “Most physicians have never seen this level of angst and anxiety in their careers”…. One said “I am sort of a pariah in my family.”
PART 15. March 22, 2020. CORONAVIRUS. “…Crimson Contagion” and imagining an influenza pandemic, was simulated by the Trump administration….in a series of exercises that ran from last January to August.
PART 16. March 27, 2020. CORONAVIRUS. I am not a clinician or a medical ethicist but articles on Coronavirus patient triage started me Googling………to learn about FUTILE TREATMENT
PART 17. April 2, 2020. CORONAVIRUS. Florida allows churches to continue holding services. Gun stores deemed “essential.” “New York’s private and public hospitals unite to manage patient load and share resources.
PART 18. April 9, 2020. CORONAVIRUS. “The federal government’s emergency stockpile of personal protective equipment (PPE) is depleted, and states will not be receiving any more shipments, administration staff told a House panel.
PART 19. April 13, 2020 CORONOAVIRUS. “…overlooked in the United States’ halting mobilization against the novel coronavirus: the personal aides, hospice attendants, nurses and occupational or physical therapists who deliver medical or support services to patients in their homes.”
POST 22. April 29, 2020. CORONAVIRUS. ..the “ACS released a list of 10 issues that should be addressed before a healthcare organization resumes elective surgeries[JM1] ….”
POST 23. May 3, 2020. CORONAVIRUS. … what Dr. Fauci really wants,…”is just to go to a baseball game. That will have to wait. The level of testing for the virus is not adequate enough to allow for such mass gatherings.’ (K)
POST 24. May 7, 2020. CORONAVIRUS. Former New Jersey governor Chris Christie said: “there are going to be deaths no matter what”… but that people needed to get back to work.
POST 25. May 10, 2020, CORONAVIRUS. “It is scary to go to work,” said Kevin Hassett, a top economic adviser to the president. “I think that I’d be a lot safer if I was sitting at home than I would be going to the West Wing.”
POST 26. May 14, 2020. CORONAVIRUS, “Deep cleaning is not a scientific concept”….”there is no universal protocol for a “deep clean” to eradicate the coronavirus”
POST 27. May 19, 2020. CORONAVIRUS. “Hospital…executives…are taking pay cuts…to help offset the financial fallout from COVID-19.” As “front line” layoffs and furloughs accelerate…
POST 28. May 23, 2020. CORONAVIRUS. ““You’ve got to be kidding me,”..”How could the CDC make that mistake? This is a mess.” CDC conflates viral and antibody tests numbers.
PART 29. May 22, 2020. CORONAVIRUS. “The economy did not close down. It closed down for people who, frankly, had the luxury of staying home,” (Governor Cuomo). But not so for frontline workers!
POST 30. June 3,202. CORONAVIRUS. “The wave of mass protests across the United States will almost certainly set off new chains of infection for the novel coronavirus, experts say….
Post 32. June 16, 2020. CORONAVIRUS. Could the Trump administration be pursuing herd immunity by “inaction”? “ If Fauci didn’t exist, we’d have to invent him.”
POST 34. June 26, 2020. CORONAVIRUS. CDC Director Redfield… “the number of coronavirus infections…could be 10 times higher than the confirmed case count — a total of more than 20 million.” As Florida, Texas and Arizona become eipicenters!
POST 35. June 29, 2020. CORONAVIRUS. Pence: “We slowed the spread. We flattened the curve. We saved lives..” While Dr. Fauci “warned that outbreaks in the South and West could engulf the country…”
POST 36. July 2, 2020. CORONAVIRUS. “There’s just a handful of interventions proven to curb the spread of the coronavirus. One of them is contact tracing, and “it’s not going well,” (Dr. Anthony Fauci)..
POST 37. June 8, 2020. CORONAVIRUS. When “crews arrive at a hospital with a patient suspected of having COVID-19, the hospital may have a physical bed open for them, but not enough nurses or doctors to staff it.”
POST 38. July 15, 2020. CORONAVIRUS. Some Lessons Learned, or not. AdventHealth CEO Terry Shaw: I wouldn’t hesitate to go to Disney as a healthcare CEO — based on the fact that they’re working extremely hard to keep people safe,” (M)
POST 39. July, 23,2020. CORONAVIRUS. A Tale of Two Cities. Seattle becomes New York (rolls back reopening) while New York becomes Seattle (moves to partial phase 4 reopening)
POST 40. July 27, 2020. CORONAVIRUS.” One canon of medical practice is that you order a test only if you can act on the result. And with a turnaround time of a week or two, you cannot. What we have now is often not testing — it’s testing theater.”
POST 41. August 2, 2020. CORONAVIRUS. “Whenever a vaccine for the coronavirus becomes available, one thing is virtually certain: There won’t be enough to go around. That means there will be rationing.”
“Someone will have to decide which of the world’s 7.8 billion people gets first crack at returning to a more normal life. Infectious disease experts and medical ethicists say this exceptionally complex decision must weigh not only who is most at risk from the virus and who is most likely to spread it, but also who is most important for maintaining the medical and financial health of a nation as well as its safety…
Arthur Caplan, a bioethicist at New York University, said the rush to bring vaccines to market likely will leave many questions unanswered at first about how well they work in different groups. He sees the first public doses as an extension of clinical trials. That will require careful tracking of recipients. “We keep acting as if the race to get FDA approval is the end of things,” he said. “I would say it’s just the start.”..
Traditionally, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends who should get vaccines, and it has been discussing since April how to divvy up a new coronavirus shot. It is unclear whether officials from the Trump administration’s Operation Warp Speed on vaccine development will want in on the decision as well. “It’s a black box,” said Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. He thinks Warp Speed will probably focus on distribution. The National Academy of Medicine, at the behest of the National Institutes of Health, has also created an expert panel to study the issue.
At the panel’s first meeting on Friday, Victor Dzau, the academy’s president, said he expected final recommendations by late September to early October. CDC Director Robert Redfield stressed that it was important for Americans to see vaccine allocation as “equitable, fair, and transparent.”
National Institutes of Health Director Francis Collins, who has faced some criticism for potentially adding to decision-making confusion, said this issue is so thorny, we can benefit from extra “deep thinkers.”
“This is going to be controversial,” he said. “Not everybody is going to like the answer.”
Caplan favors an independent commission that includes both scientists and representatives of affected communities, such as people with disabilities and children. Whoever makes the decisions, he said, “it’s got to be trustworthy.”..
Who goes first?
Priorities need to consider the multiple public health roles vaccines can play, said William Schaffner, an infectious diseases specialist at Vanderbilt University Medical Center. Typically, younger people mount the strongest immune response, said Schaffner, who represents the National Foundation for Infectious Diseases as a liaison to ACIP. They are currently catching COVID-19 at higher rates and spreading it to other, more vulnerable populations. Vaccinating them could weaken the chain of transmission.
Older people and those with chronic health problems are clearly getting sickest, but vaccines tend to be less effective in these groups. A third group are “the people in society that are responsible for its most essential functions,” Schaffner said: medical workers, police and firefighters, those who make, sell and distribute food.
Schaffner said it’s important not to create such narrow categories that vaccine sits unused in refrigerators. “Vaccine does not prevent disease,” he said. “Immunization prevents disease.”” (A)
“Last month, National Institutes of Health Director Francis Collins called the National Academy of Medicine asking for help: Would the esteemed group be interested in developing guidelines for who should get the first doses of a coronavirus vaccine?
“It will allow the public to know it’s transparent, it’s not political,” said Dr. Victor Dzau, the academy’s president who told Collins that his organization was up to the task. “The American public will want to know how are you making that decision? Why am I not getting it first?”
After months of missteps and criticism across the political spectrum on everything from testing to personal protective equipment, the Trump administration is aiming to prove it can roll out a coronavirus vaccine quickly and fairly to millions of Americans as soon as one is ready. That means tackling thorny challenges like deciding who is first in line for vaccination, securing millions of glass vials and syringes and convincing Americans to get inoculated.
The administration is making moves that experts applaud like tapping top health officials and industry experts to lead vaccine plans rather than politicians, but they are still concerned that the overall effort — dubbed Operation Warp Speed — remains shrouded in secrecy. And the administration’s response to the rest of the pandemic has not inspired confidence.
“It’s sort of being handled like a secret weapon, which is never good,” said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “Transparency is always good.”
Once a vaccine is approved, every American won’t be able to get it at once. That sets up the unenviable task of deciding, amid a deadly pandemic, who is most vulnerable to the disease and who is most essential to inoculate quickly.
“People are a little uneasy about the government calling the shots here,” NIH’s Dr. Collins told a Senate panel earlier this month.
Experts will have to consider vulnerable populations like those in assisted-living facilities or prisons, people working in close quarters like meat packing plants and how to assess Americans with preexisting conditions.
The National Academy of Medicine hopes to have its recommendations publicly available in August or September.
A second panel of vaccine advisers for the Centers for Disease Control and Prevention — the Advisory Committee on Immunization Practices (ACIP) — is also coming up with a set of guidelines. It’s still unclear whether the administration will select one set of recommendations over the other or take both into account when making its final decisions.
Last month, the ACIP convened electronically in a little-noticed meeting to discuss who counts as an essential worker, where teachers should fall in the priority list, vaccinations for pregnant women and whether race and ethnicity should factor into priority considerations.
“If we fail to address this issue of racial and ethnic groups as a high risk in prioritization, whatever comes out of our group will be looked at very suspiciously and with a lot of reservation,” Dr. José Romero, the panel’s chairman, said….
Once a vaccine is available, it could still take six months to a year to vaccinate enough of the population to slow the spread…
The CDC and Pentagon are working in tandem to deliver the vaccine across America, though they haven’t offered many details about how they plan to do so….
Convincing minority communities that have experienced higher rates of hospitalization and fatality to get vaccinated is a top concern. Experts said that will have to involve community outreach through organizations people already trust, such as faith-based organizations.
“There’s a lot of work that needs to be done in terms of making sure we that engage them earlier to gain their trust,” Dzau of the National Academy of Medicine said. “There are two ways that people can look at it. One is, are we the guinea pig? Or, two, we should get it first because we are more at risk.”” (B)
Why do we need more than one vaccine?
We’ll benefit from several vaccines, said Pulendran, because no single company could meet demand. In addition, the vaccines may differ, working better in some people than others.
“If we’ve got three acceptable vaccines, we’ll get the vaccine to more people,” said Ernst. “Maybe not everybody will get the best vaccine for somebody in their demographic. But assuming they’re equally safe and differ in efficacy only a modest amount, you’re better off being vaccinated than having no vaccine at all.”
Why first isn’t always best
Remember the Salk vs.Sabin polio vaccine debate? We started with Salk’s version, then shifted to Sabin’s. Now, with more information, we’re back to Salk’s.
Imagine that our first vaccine is only 50% effective. (The U.S. Food and Drug Administration, in an apparent effort to encourage vaccine companies, says that’s good enough for licensing, for now.) That will still leave some people, such as the elderly and those with high-risk medical conditions, perilously exposed.
If we’re lucky, vaccines will get better over time.
“It may not be the ultimate vaccine, but it’s the first iteration that can be improved upon,” said Pulendran.
“50% effective” sounds like more mask-wearing. Why can’t we do better?..
Who’s first in line?
If you’re an average healthy adult, you’ll likely be last in line. Health care workers and people at high medical risk would likely be first, Dr. Francis Collins, director of the National Institutes of Health, said Friday.
But there are other considerations. The military, students, underrepresented minorities, “essential workers” or people who volunteered for research may get priority too. If there’s an explosive local outbreak, vaccinating everyone nearby would limit the spread…
How will it be distributed?
Companies have said they’ll defer to the federal government. But experts, noting the disastrous distribution of PPE and tests, say we should look to the multi-channel distribution model of flu vaccines. They say it should be available from governments and doctors — but also directly from the companies, via CVS, Walgreens and other local pharmacies.
“It’s still inconceivable that we’ll be able to get vaccines to 330 million in three to six months,” Dr. Robert Wachter, chair of the Department of Medicine at UC San Francisco, tweeted this past week. During the 2009 swine flu epidemic, he noted, we vaccinated about one-quarter of all Americans — and that took six months.
Vaccinating 80 to 100 million of the nation’s most vulnerable people, including healthcare workers, “might be do-able by mid-’21,” he said.
Not everybody wants one.
Even people who believe in vaccines are showing reluctance to get the COVID-19 vaccine. They worry that politics are creating undue pressure, and corners will be cut in the rush to produce. Only about half of Americans say they would get a COVID-19 vaccine, according to a May poll from The Associated Press-NORC Center for Public Affairs Research. One-third weren’t sure and one-fifth would refuse, citing safety concerns.
If a vaccine is 50% effective, and 50% of the population gets vaccinated, then only 25% of the population is protected, said Ernst.
That’s far short of the 70% protection needed to stop this pandemic. The only solution is to make a better vaccine — and convince more people to take it.
“We’re not going to get this disease under control by just vaccinating health care workers and kindergarten teachers,” said Ernst.
“We need to be thinking about how are we going to convince people to comply with vaccinations,” he said, “so that we’ve got a sufficient amount of the population covered to actually get COVID-19 under control.” (C)
“Federal health officials are already trying to decide who will get the first doses of any effective coronavirus vaccines, which could be on the market this winter but could require many additional months to become widely available to Americans.
The Centers for Disease Control and Prevention and an advisory committee of outside health experts in April began working on a ranking system for what may be an extended rollout in the United States. According to a preliminary plan, any approved vaccines would be offered to vital medical and national security officials first, and then to other essential workers and those considered at high risk — the elderly instead of children, people with underlying conditions instead of the relatively healthy.
Agency officials and the advisers are also considering what has become a contentious option: putting Black and Latino people, who have disproportionately fallen victim to Covid-19, ahead of others in the population.
In private meetings and a recent public session, the issue has provoked calls for racial justice. But some medical experts are not convinced there is a scientific basis for such an option, foresee court challenges or worry that prioritizing minority groups would erode public trust in vaccines at a time when immunization is seen as crucial to ending the pandemic.
“Giving it to one race initially and not another race, I’m not sure how that would be perceived by the public, how that would affect how vaccines are viewed as a trusted public health measure,” said Claire Hannan, executive director of the Association of Immunization Managers, a group represented on the committee.
While there is a standard protocol for introducing vaccines — the C.D.C. typically makes recommendations and state and local public health departments decide whether to follow them — the White House has pressed the agency at times to revise or hold off on proposals it found objectionable. President Trump, who has been pushing to reopen schools, fill workplaces and hold large public events, has been acutely focused on the political consequences of public health guidance…
To speed distribution, the most promising vaccines will start being made even before they have cleared the final stages of clinical trials and been authorized for public use by the Food and Drug Administration.
But there will be a gap between the first doses coming off the manufacturing lines and a stockpile large enough to vaccinate the U.S. population. “I would say months,” Dr. José R. Romero, the chairman of the Advisory Committee on Immunization Practices, predicted.
The committee, which reports to the C.D.C. director, has long played a key role in determining how to implement new vaccines. The group includes 15 voting members selected by the health secretary who come from immunology, infectious disease and other medical specialties, 30 nonvoting representatives from across the health field, and eight federal officials focused on vaccines. Still, it operates largely out of sight.
Dr. Romero is among four committee members who have been deliberating on the plans since this spring alongside doctors at the C.D.C., representatives from the health field, ethicists and other outside consultants. In June, they briefed the full committee on their work, offering a glimpse of the questions being considered.
As they come up with a multitiered schedule for the first 1.2 million vaccine doses and then the next 110 million, they have focused on who should be considered essential workers, what underlying conditions should be taken into account and what kinds of living environments — nursing homes, homeless shelters — put people at high risk. Among the questions: What should be done about pregnant women? Should teachers go toward the front of the line? Should prisoners be in a top tier?
But for the broader committee, questions of whether to prioritize race and ethnicity sparked the most debate.
Black and Latino people have become infected with the virus at three times the rate of whites, and have died nearly twice as frequently. Many of them have jobs that keep them from working at home, rely on public transportation or live in cramped homes that increase their risk of exposure. They are more likely to suffer from underlying health problems, including diabetes and obesity, that raise the risk of hospitalization and death. Not only do the groups have less access to health services, they have a documented history of receiving unequal care.” (H)
“But let’s suppose that health care workers and people with underlying medical conditions use up the first doses of the available vaccine. Should some be held in reserve for Black and Latino people? What about bus drivers and train conductors? Perhaps teachers or schoolchildren should get it so they can return to classrooms with peace of mind.
If shortages happen, most of the nation will have no chance to get the initial lots of a vaccine under the C.D.C.’s plan. And as the United States combats a soaring number of coronavirus cases, rising demand for drugs and maybe ventilators is expected. They, too, will need a fair system of distribution.
One solution that is starting to attract the attention of public health experts is a so-called weighted lottery, which gives everyone a chance at access, although some get a better shot than others.
Doctors and ethicists rank patients, deciding which groups should be given preference and how much. First-responders, for example, may be weighted more heavily than, say, very sick patients who are unlikely to recover.
The goal is to prevent haphazard or inequitable distribution of a treatment or vaccine when there isn’t enough to go around. Such a system has already been used in allocations of remdesivir, the first drug shown to be effective against the coronavirus.
“This is all very new,” said Dr. Douglas White, an ethicist and vice chairman of the department of critical medicine at the University of Pittsburgh, which began using a weighted lottery last month to distribute remdesivir.
Patients have accepted the results, even when they lost in the lottery and ended up being denied the drug, he added.
“I speculate that is because we are very transparent about the reason and the ethical framework that applies to everyone who comes into hospital, whether that is the hospital president or someone who is homeless,” he said.
To allocate the drug, Pittsburgh doctors decided that the lottery would give preference to health care workers and emergency medical workers. The doctors also weighted the odds to favor people from economically disadvantaged areas, who tend to be mostly Black and Hispanic.
People with other illnesses and limited life spans, like end-stage cancer patients, had the odds weighted against them, giving them a smaller chance to win in the lottery. The system did not consider age, race, ethnicity, quality of life, ability to pay or whether a patient has a disability.
The lottery began in early June, Dr. White said: “We had 64 patients. We had to make the supply of remdesivir last at least two weeks. We only had enough to treat one in four patients.”
They had a brief respite from the lottery when cases began falling and supplies of remdesivir seemed adequate. But on Sunday, with cases rising again and enough remdesivir for only about half the patients who could be helped by taking it, the hospital system was forced to go back to a lottery….
Still, in principle, lottery data about a vaccine can be as useful as randomized clinical trial data, Dr. Pathak said.
“We would like to get people to think ahead about how vaccines are allocated,” he said. “There is no way we can vaccinate everybody, so we have to think about what’s fair and what’s just.”” (D)
“TA: Given that equitable distribution of vaccines is, at least in part, a question of ethics, how can computer models help us arrive at a solution?
Swann: It’s an interesting intersection, isn’t it? We can think of problems in terms of our objectives, which in this case might include efficiency (speed), effectiveness (avert deaths), and equity across the population. In public health, equity can be defined in different ways, including geographically (urban and rural) or by population (pro-rata). It can also be defined in terms of outcomes. For example, right now we know that communities of color, including African Americans, Hispanics, and Native Americans, are experiencing much higher rates of COVID-19 mortality than whites, and we know that people who are older or have high-risk medical conditions are also experiencing greater mortality than others.
Computer models can do many things to help with equitable distribution of vaccines. One really important role is to project the impact of different vaccination scenarios or strategies. For example, if there are limited vaccines, what is the impact of vaccinating essential workers, or ones who might interact with a vulnerable group (e.g., nursing home workers)? If there is a group at lower direct risk (e.g., children) who have significant contact with people at risk (parents or grandparents), what would be the impact of vaccinating them? If a vaccine requires two doses, or if immunity wanes after a time period, what strategies can avert the most hospitalizations and deaths? Which strategies would be most effective at reducing the disparities in COVID-19 outcomes associated with communities of color? These are just a few examples of many different decisions where humans could be aided by input from computer models.” (I)
“Nationwide distribution of any coronavirus vaccine will be a “joint venture” between the Centers for Disease Control and Prevention, which typically oversees vaccine allocation, and the Department of Defense, a senior administration official said today.
The Department of Defense “is handling all the logistics of getting the vaccines to the right place, at the right time, in the right condition,” the official said in a call with reporters, adding that CDC will remain in charge of tracking any side effects that emerge post-vaccination and “some of the communications through the state relationships [and] the state public health organizations.”
The plan breaks with the longstanding precedent that CDC distributes vaccines during major outbreaks — such as bad flu seasons — through a centralized ordering system for state and local health officials.
“We believe we’ve actually combined the best of both,” the official said. A second senior administration official stressed the agencies would be working as “one team” to distribute hundreds of millions of doses if any of the vaccines in development are approved in the coming months.
Private companies are also likely to join the effort. The first official said the government is bringing in people to integrate CDC IT capabilities with “some new applications that we’re going to need that the CDC never had.”
The background: The Pentagon will be guiding not just distribution logistics but also manufacturing and “kitting,” the process of safely packaging a vaccine with its necessary equipment such as syringes and needles.
“The DoD is handling all of those logistics — that is where their comparative advantage is,” said the first senior official. “And the CDC, some of their IT systems, relationships with the states following post-vaccination will belong to them.”…
State and local government groups have already raised concerns about Pentagon involvement and using new methods in coronavirus vaccine distribution. The CDC “already leads and maintains a highly effective system of vaccine ordering and distribution,” groups including the Association of State and Territorial Health Officials wrote in June. “With time of the essence we strongly recommend against designing new and untested systems of vaccine distribution.”
The state and local officials also questioned whether military involvement in vaccine administration would undermine already shaky public confidence in vaccines.” (G)
“Executives from four companies in the race to produce a coronavirus vaccine — AstraZeneca, Johnson & Johnson, Moderna Therapeutics and Pfizer — told lawmakers on Tuesday that they are optimistic their products could be ready by the end of 2020 or the beginning of 2021. All four companies are testing vaccines in human clinical trials.
Three of the firms — AstraZeneca, Johnson & Johnson and Moderna — are getting federal funds for their vaccine development efforts. AstraZeneca and Johnson & Johnson pledged to the lawmakers that they would produce hundreds of millions of doses of their vaccines at no profit to themselves. Moderna, however, which has been granted $483 million from the government to develop its product, made no such promise.
“We will not sell it at cost,” said Dr. Stephen Hoge, the president of Moderna.
Many Democratic lawmakers have argued that federal funding for vaccine development should include provisions to guarantee affordability and guard against profiteering.
At the Congressional hearing on Tuesday, some House members raised concerns about Pfizer’s decision to reject federal funds, suggesting it could lead to price-gouging and a lack of transparency… (E)
“On June 26, a small South San Francisco company called Vaxart made a surprise announcement: A coronavirus vaccine it was working on had been selected by the U.S. government to be part of Operation Warp Speed, the flagship federal initiative to quickly develop drugs to combat Covid-19.
Vaxart’s shares soared. Company insiders, who weeks earlier had received stock options worth a few million dollars, saw the value of those awards increase sixfold. And a hedge fund that partly controlled the company walked away with more than $200 million in instant profits.” (F)
“The Serum Institute, which is exclusively controlled by a small and fabulously rich Indian family and started out years ago as a horse farm, is doing what a few other companies in the race for a vaccine are doing: mass-producing hundreds of millions of doses of a vaccine candidate that is still in trials and might not even work.
But if it does, Adar Poonawalla, Serum’s chief executive and the only child of the company’s founder, will become one of the most tugged-at men in the world. He will have on hand what everyone wants, possibly in greater quantities before anyone else.
His company, which has teamed up with the Oxford scientists developing the vaccine, was one of the first to boldly announce, in April, that it was going to mass-produce a vaccine before clinical trials even ended. Now, Mr. Poonawalla’s fastest vaccine assembly lines are being readied to crank out 500 doses each minute, and his phone rings endlessly.
National health ministers, prime ministers and other heads of state (he wouldn’t say who) and friends he hasn’t heard from in years have been calling him, he said, begging for the first batches.
“I’ve had to explain to them that, ‘Look I can’t just give it to you like this,’” he said.
With the coronavirus pandemic turning the world upside down and all hopes pinned on a vaccine, the Serum Institute finds itself in the middle of an extremely competitive and murky endeavor. To get the vaccine out as soon as possible, vaccine developers say they need Serum’s mammoth assembly lines — each year, it churns out 1.5 billion doses of other vaccines, mostly for poor countries, more than any other company…
But right now it’s not entirely clear how much of the coronavirus vaccine that Serum will mass-produce will be kept by India or who will fund its production, leaving the Poonawallas to navigate a torrent of cross-pressures, political, financial, external and domestic.
India has been walloped by the coronavirus, and with 1.3 billion people, it needs vaccine doses as much as anywhere. It’s also led by a highly nationalistic prime minister, Narendra Modi, whose government has already blocked exports of drugs that were believed to help treat Covid-19, the disease caused by the coronavirus.
Adar Poonawalla, 39, says that he will split the hundreds of millions of vaccine doses he produces 50-50 between India and the rest of the world, with a focus on poorer countries, and that Mr. Modi’s government has not objected to this.” (J)
“First we have to look at the global level. The private sector is really driving the vaccine development process, rather than government or academic labs. Major efforts are underway to figure out how private industrial developers can make vaccines available at an affordable price to all countries, particularly low and middle-income countries. It’s a bit like the ventilator supply situation we’ve all faced, but on steroids. Initially there will be scarce supply of the vaccine, governments will be scrambling to procure it, and, unless these efforts work, the winners will be fairly predictable: countries that have the resources.
On the next level, some wealthy countries will likely end up with substantial amounts of vaccine. Over time, if all goes well, these countries will have to decide how much product they’re going to keep and how much, if any, they’re willing to share with other countries where the vaccine may be in very short supply. These are complex questions of ethics, and they’re wrapped up in geopolitics, and also national politics.
There’s a term called vaccine nationalism—where countries understand their obligations to be primarily, if not exclusively, to their own residents. Although there is an expectation that countries with the resources and production capacity will meet their own health needs first, should they ignore the needs of people living in other countries with severe economic constraints? From an ethics perspective, a balance must be struck.” (K)
“As soon as the first COVID-19 vaccines get approved, a staggering global need will confront limited supplies. Many health experts say it’s clear who should get the first shots: health care workers around the world, then people at a higher risk of severe disease, then those in areas where the disease is spreading rapidly, and finally, the rest of us. Such a strategy “saves the most lives and slows transmission the fastest,” says Christopher Elias, who heads the Bill & Melinda Gates Foundation’s Global Development Division. “It would be ludicrous if low-risk people in rich countries get the vaccine when health care workers in South Africa don’t,” adds Ellen ‘t Hoen, a Dutch lawyer and public health activist.
Yet money and national interest may win out. The United States and Europe are placing advance orders for hundreds of millions of doses of successful vaccines, potentially leaving little for poorer parts of the world. “I’m very concerned,” says John Nkengasong, director of the Africa Centres for Disease Control and Prevention.
To avoid such a scenario, the World Health Organization and other international organizations have set up a system to accelerate and equitably distribute vaccines, the COVID-19 Vaccines Global Access (COVAX) Facility, which seeks to entice rich countries to sign on by reducing their own risk that they’re betting on the wrong vaccine candidates. But the idea has been put together on the fly, and it’s unclear how many rich countries will join.” (L)
“As scientists and pharmaceutical companies work at breakneck speed to develop a vaccine for the novel coronavirus, public health officials and senior U.S. lawmakers are sounding alarms about the Trump administration’s lack of planning for its nationwide distribution.
The federal government traditionally plays a principal role in funding and overseeing the manufacturing and distribution of new vaccines, which often draw on scarce ingredients and need to be made, stored and transported carefully.
There won’t be enough vaccine for all 330 million Americans right away, so the government also has a role in deciding who gets it first, and in educating a vaccine-wary here public about its potential life saving merits.
Right now, it is unclear who in Washington is in charge of oversight, much less any critical details, some state health officials and members of Congress told Reuters…
Health officials and lawmakers say they worry that without thorough planning and coordination with states, the vaccine distribution could be saddled with the same sort of disruptions that led to chronic shortages of coronavirus diagnostic tests and other medical supplies…
Some state public health officials, meanwhile, say their entreaties to the Trump administration have been unanswered.
“We have not heard anything from the federal government since April 23,” Danielle Koenig, health promotion supervisor for the Washington State Department of Health, said in an email.
That is when her agency received preliminary guidance on vaccine planning from the CDC.
Immunization experts along with state and local public health officials sent a letter here to Operation Warp Speed on June 23 pleading for fresh guidance.
States need to know promptly if the federal government will pay for the vaccines, as it did during the H1N1 outbreak in 2009, the letter says. Will alcohol swabs, syringes and personal protective equipment be included? What about record-keeping and refrigeration to store the vaccine and who will deliver it?
So far, there’s been no official response, said Claire Hannan, executive director of the Association of Immunization Managers, one of four organizations that signed the letter.
“We urgently await federal, state and local collaborative discussions to identify challenges and plan solutions. A vaccination campaign of this magnitude is unprecedented and it’s going to take more than an army,” Hannan said on Tuesday, referring to Trump’s repeated statements that the U.S. military stands ready to deliver vaccines.
Trump insists everything is in place.
“We’re all set to march when it comes to the vaccine,” Trump said at a White House briefing on Thursday. “… And the delivery system is all set. Logistically we have a general that’s all he does is deliver things whether it is soldiers or other items.
“We are way ahead on vaccines, way ahead on therapeutics and when we have it we are all set with our platforms to deliver them very, very quickly,” Trump said. (M)
“Someone will have to decide which of the world’s 7.8 billion people gets first crack at returning to a more normal life. Infectious disease experts and medical ethicists say this exceptionally complex decision must weigh not only who is most at risk from the virus and who is most likely to spread it, but also who is most important for maintaining the medical and financial health of a nation as well as its safety…
Arthur Caplan, a bioethicist at New York University, said the rush to bring vaccines to market likely will leave many questions unanswered at first about how well they work in different groups. He sees the first public doses as an extension of clinical trials. That will require careful tracking of recipients. “We keep acting as if the race to get FDA approval is the end of things,” he said. “I would say it’s just the start.”..
Traditionally, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends who should get vaccines, and it has been discussing since April how to divvy up a new coronavirus shot. It is unclear whether officials from the Trump administration’s Operation Warp Speed on vaccine development will want in on the decision as well. “It’s a black box,” said Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. He thinks Warp Speed will probably focus on distribution. The National Academy of Medicine, at the behest of the National Institutes of Health, has also created an expert panel to study the issue.
At the panel’s first meeting on Friday, Victor Dzau, the academy’s president, said he expected final recommendations by late September to early October. CDC Director Robert Redfield stressed that it was important for Americans to see vaccine allocation as “equitable, fair, and transparent.”
National Institutes of Health Director Francis Collins, who has faced some criticism for potentially adding to decision-making confusion, said this issue is so thorny, we can benefit from extra “deep thinkers.”
“This is going to be controversial,” he said. “Not everybody is going to like the answer.”
Caplan favors an independent commission that includes both scientists and representatives of affected communities, such as people with disabilities and children. Whoever makes the decisions, he said, “it’s got to be trustworthy.”..
Who goes first?
Priorities need to consider the multiple public health roles vaccines can play, said William Schaffner, an infectious diseases specialist at Vanderbilt University Medical Center. Typically, younger people mount the strongest immune response, said Schaffner, who represents the National Foundation for Infectious Diseases as a liaison to ACIP. They are currently catching COVID-19 at higher rates and spreading it to other, more vulnerable populations. Vaccinating them could weaken the chain of transmission.
Older people and those with chronic health problems are clearly getting sickest, but vaccines tend to be less effective in these groups. A third group are “the people in society that are responsible for its most essential functions,” Schaffner said: medical workers, police and firefighters, those who make, sell and distribute food.
Schaffner said it’s important not to create such narrow categories that vaccine sits unused in refrigerators. “Vaccine does not prevent disease,” he said. “Immunization prevents disease.”” (A)
“Last month, National Institutes of Health Director Francis Collins called the National Academy of Medicine asking for help: Would the esteemed group be interested in developing guidelines for who should get the first doses of a coronavirus vaccine?
“It will allow the public to know it’s transparent, it’s not political,” said Dr. Victor Dzau, the academy’s president who told Collins that his organization was up to the task. “The American public will want to know how are you making that decision? Why am I not getting it first?”
After months of missteps and criticism across the political spectrum on everything from testing to personal protective equipment, the Trump administration is aiming to prove it can roll out a coronavirus vaccine quickly and fairly to millions of Americans as soon as one is ready. That means tackling thorny challenges like deciding who is first in line for vaccination, securing millions of glass vials and syringes and convincing Americans to get inoculated.
The administration is making moves that experts applaud like tapping top health officials and industry experts to lead vaccine plans rather than politicians, but they are still concerned that the overall effort — dubbed Operation Warp Speed — remains shrouded in secrecy. And the administration’s response to the rest of the pandemic has not inspired confidence.
“It’s sort of being handled like a secret weapon, which is never good,” said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “Transparency is always good.”
Once a vaccine is approved, every American won’t be able to get it at once. That sets up the unenviable task of deciding, amid a deadly pandemic, who is most vulnerable to the disease and who is most essential to inoculate quickly.
“People are a little uneasy about the government calling the shots here,” NIH’s Dr. Collins told a Senate panel earlier this month.
Experts will have to consider vulnerable populations like those in assisted-living facilities or prisons, people working in close quarters like meat packing plants and how to assess Americans with preexisting conditions.
The National Academy of Medicine hopes to have its recommendations publicly available in August or September.
A second panel of vaccine advisers for the Centers for Disease Control and Prevention — the Advisory Committee on Immunization Practices (ACIP) — is also coming up with a set of guidelines. It’s still unclear whether the administration will select one set of recommendations over the other or take both into account when making its final decisions.
Last month, the ACIP convened electronically in a little-noticed meeting to discuss who counts as an essential worker, where teachers should fall in the priority list, vaccinations for pregnant women and whether race and ethnicity should factor into priority considerations.
“If we fail to address this issue of racial and ethnic groups as a high risk in prioritization, whatever comes out of our group will be looked at very suspiciously and with a lot of reservation,” Dr. José Romero, the panel’s chairman, said….
Once a vaccine is available, it could still take six months to a year to vaccinate enough of the population to slow the spread…
The CDC and Pentagon are working in tandem to deliver the vaccine across America, though they haven’t offered many details about how they plan to do so….
Convincing minority communities that have experienced higher rates of hospitalization and fatality to get vaccinated is a top concern. Experts said that will have to involve community outreach through organizations people already trust, such as faith-based organizations.
“There’s a lot of work that needs to be done in terms of making sure we that engage them earlier to gain their trust,” Dzau of the National Academy of Medicine said. “There are two ways that people can look at it. One is, are we the guinea pig? Or, two, we should get it first because we are more at risk.”” (B)
Why do we need more than one vaccine?
We’ll benefit from several vaccines, said Pulendran, because no single company could meet demand. In addition, the vaccines may differ, working better in some people than others.
“If we’ve got three acceptable vaccines, we’ll get the vaccine to more people,” said Ernst. “Maybe not everybody will get the best vaccine for somebody in their demographic. But assuming they’re equally safe and differ in efficacy only a modest amount, you’re better off being vaccinated than having no vaccine at all.”
Why first isn’t always best
Remember the Salk vs.Sabin polio vaccine debate? We started with Salk’s version, then shifted to Sabin’s. Now, with more information, we’re back to Salk’s.
Imagine that our first vaccine is only 50% effective. (The U.S. Food and Drug Administration, in an apparent effort to encourage vaccine companies, says that’s good enough for licensing, for now.) That will still leave some people, such as the elderly and those with high-risk medical conditions, perilously exposed.
If we’re lucky, vaccines will get better over time.
“It may not be the ultimate vaccine, but it’s the first iteration that can be improved upon,” said Pulendran.
“50% effective” sounds like more mask-wearing. Why can’t we do better?..
Who’s first in line?
If you’re an average healthy adult, you’ll likely be last in line. Health care workers and people at high medical risk would likely be first, Dr. Francis Collins, director of the National Institutes of Health, said Friday.
But there are other considerations. The military, students, underrepresented minorities, “essential workers” or people who volunteered for research may get priority too. If there’s an explosive local outbreak, vaccinating everyone nearby would limit the spread…
How will it be distributed?
Companies have said they’ll defer to the federal government. But experts, noting the disastrous distribution of PPE and tests, say we should look to the multi-channel distribution model of flu vaccines. They say it should be available from governments and doctors — but also directly from the companies, via CVS, Walgreens and other local pharmacies.
“It’s still inconceivable that we’ll be able to get vaccines to 330 million in three to six months,” Dr. Robert Wachter, chair of the Department of Medicine at UC San Francisco, tweeted this past week. During the 2009 swine flu epidemic, he noted, we vaccinated about one-quarter of all Americans — and that took six months.
Vaccinating 80 to 100 million of the nation’s most vulnerable people, including healthcare workers, “might be do-able by mid-’21,” he said.
Not everybody wants one.
Even people who believe in vaccines are showing reluctance to get the COVID-19 vaccine. They worry that politics are creating undue pressure, and corners will be cut in the rush to produce. Only about half of Americans say they would get a COVID-19 vaccine, according to a May poll from The Associated Press-NORC Center for Public Affairs Research. One-third weren’t sure and one-fifth would refuse, citing safety concerns.
If a vaccine is 50% effective, and 50% of the population gets vaccinated, then only 25% of the population is protected, said Ernst.
That’s far short of the 70% protection needed to stop this pandemic. The only solution is to make a better vaccine — and convince more people to take it.
“We’re not going to get this disease under control by just vaccinating health care workers and kindergarten teachers,” said Ernst.
“We need to be thinking about how are we going to convince people to comply with vaccinations,” he said, “so that we’ve got a sufficient amount of the population covered to actually get COVID-19 under control.” (C)
“Federal health officials are already trying to decide who will get the first doses of any effective coronavirus vaccines, which could be on the market this winter but could require many additional months to become widely available to Americans.
The Centers for Disease Control and Prevention and an advisory committee of outside health experts in April began working on a ranking system for what may be an extended rollout in the United States. According to a preliminary plan, any approved vaccines would be offered to vital medical and national security officials first, and then to other essential workers and those considered at high risk — the elderly instead of children, people with underlying conditions instead of the relatively healthy.
Agency officials and the advisers are also considering what has become a contentious option: putting Black and Latino people, who have disproportionately fallen victim to Covid-19, ahead of others in the population.
In private meetings and a recent public session, the issue has provoked calls for racial justice. But some medical experts are not convinced there is a scientific basis for such an option, foresee court challenges or worry that prioritizing minority groups would erode public trust in vaccines at a time when immunization is seen as crucial to ending the pandemic.
“Giving it to one race initially and not another race, I’m not sure how that would be perceived by the public, how that would affect how vaccines are viewed as a trusted public health measure,” said Claire Hannan, executive director of the Association of Immunization Managers, a group represented on the committee.
While there is a standard protocol for introducing vaccines — the C.D.C. typically makes recommendations and state and local public health departments decide whether to follow them — the White House has pressed the agency at times to revise or hold off on proposals it found objectionable. President Trump, who has been pushing to reopen schools, fill workplaces and hold large public events, has been acutely focused on the political consequences of public health guidance…
To speed distribution, the most promising vaccines will start being made even before they have cleared the final stages of clinical trials and been authorized for public use by the Food and Drug Administration.
But there will be a gap between the first doses coming off the manufacturing lines and a stockpile large enough to vaccinate the U.S. population. “I would say months,” Dr. José R. Romero, the chairman of the Advisory Committee on Immunization Practices, predicted.
The committee, which reports to the C.D.C. director, has long played a key role in determining how to implement new vaccines. The group includes 15 voting members selected by the health secretary who come from immunology, infectious disease and other medical specialties, 30 nonvoting representatives from across the health field, and eight federal officials focused on vaccines. Still, it operates largely out of sight.
Dr. Romero is among four committee members who have been deliberating on the plans since this spring alongside doctors at the C.D.C., representatives from the health field, ethicists and other outside consultants. In June, they briefed the full committee on their work, offering a glimpse of the questions being considered.
As they come up with a multitiered schedule for the first 1.2 million vaccine doses and then the next 110 million, they have focused on who should be considered essential workers, what underlying conditions should be taken into account and what kinds of living environments — nursing homes, homeless shelters — put people at high risk. Among the questions: What should be done about pregnant women? Should teachers go toward the front of the line? Should prisoners be in a top tier?
But for the broader committee, questions of whether to prioritize race and ethnicity sparked the most debate.
Black and Latino people have become infected with the virus at three times the rate of whites, and have died nearly twice as frequently. Many of them have jobs that keep them from working at home, rely on public transportation or live in cramped homes that increase their risk of exposure. They are more likely to suffer from underlying health problems, including diabetes and obesity, that raise the risk of hospitalization and death. Not only do the groups have less access to health services, they have a documented history of receiving unequal care.” (H)
“But let’s suppose that health care workers and people with underlying medical conditions use up the first doses of the available vaccine. Should some be held in reserve for Black and Latino people? What about bus drivers and train conductors? Perhaps teachers or schoolchildren should get it so they can return to classrooms with peace of mind.
If shortages happen, most of the nation will have no chance to get the initial lots of a vaccine under the C.D.C.’s plan. And as the United States combats a soaring number of coronavirus cases, rising demand for drugs and maybe ventilators is expected. They, too, will need a fair system of distribution.
One solution that is starting to attract the attention of public health experts is a so-called weighted lottery, which gives everyone a chance at access, although some get a better shot than others.
Doctors and ethicists rank patients, deciding which groups should be given preference and how much. First-responders, for example, may be weighted more heavily than, say, very sick patients who are unlikely to recover.
The goal is to prevent haphazard or inequitable distribution of a treatment or vaccine when there isn’t enough to go around. Such a system has already been used in allocations of remdesivir, the first drug shown to be effective against the coronavirus.
“This is all very new,” said Dr. Douglas White, an ethicist and vice chairman of the department of critical medicine at the University of Pittsburgh, which began using a weighted lottery last month to distribute remdesivir.
Patients have accepted the results, even when they lost in the lottery and ended up being denied the drug, he added.
“I speculate that is because we are very transparent about the reason and the ethical framework that applies to everyone who comes into hospital, whether that is the hospital president or someone who is homeless,” he said.
To allocate the drug, Pittsburgh doctors decided that the lottery would give preference to health care workers and emergency medical workers. The doctors also weighted the odds to favor people from economically disadvantaged areas, who tend to be mostly Black and Hispanic.
People with other illnesses and limited life spans, like end-stage cancer patients, had the odds weighted against them, giving them a smaller chance to win in the lottery. The system did not consider age, race, ethnicity, quality of life, ability to pay or whether a patient has a disability.
The lottery began in early June, Dr. White said: “We had 64 patients. We had to make the supply of remdesivir last at least two weeks. We only had enough to treat one in four patients.”
They had a brief respite from the lottery when cases began falling and supplies of remdesivir seemed adequate. But on Sunday, with cases rising again and enough remdesivir for only about half the patients who could be helped by taking it, the hospital system was forced to go back to a lottery….
Still, in principle, lottery data about a vaccine can be as useful as randomized clinical trial data, Dr. Pathak said.
“We would like to get people to think ahead about how vaccines are allocated,” he said. “There is no way we can vaccinate everybody, so we have to think about what’s fair and what’s just.”” (D)
“TA: Given that equitable distribution of vaccines is, at least in part, a question of ethics, how can computer models help us arrive at a solution?
Swann: It’s an interesting intersection, isn’t it? We can think of problems in terms of our objectives, which in this case might include efficiency (speed), effectiveness (avert deaths), and equity across the population. In public health, equity can be defined in different ways, including geographically (urban and rural) or by population (pro-rata). It can also be defined in terms of outcomes. For example, right now we know that communities of color, including African Americans, Hispanics, and Native Americans, are experiencing much higher rates of COVID-19 mortality than whites, and we know that people who are older or have high-risk medical conditions are also experiencing greater mortality than others.
Computer models can do many things to help with equitable distribution of vaccines. One really important role is to project the impact of different vaccination scenarios or strategies. For example, if there are limited vaccines, what is the impact of vaccinating essential workers, or ones who might interact with a vulnerable group (e.g., nursing home workers)? If there is a group at lower direct risk (e.g., children) who have significant contact with people at risk (parents or grandparents), what would be the impact of vaccinating them? If a vaccine requires two doses, or if immunity wanes after a time period, what strategies can avert the most hospitalizations and deaths? Which strategies would be most effective at reducing the disparities in COVID-19 outcomes associated with communities of color? These are just a few examples of many different decisions where humans could be aided by input from computer models.” (I)
“Nationwide distribution of any coronavirus vaccine will be a “joint venture” between the Centers for Disease Control and Prevention, which typically oversees vaccine allocation, and the Department of Defense, a senior administration official said today.
The Department of Defense “is handling all the logistics of getting the vaccines to the right place, at the right time, in the right condition,” the official said in a call with reporters, adding that CDC will remain in charge of tracking any side effects that emerge post-vaccination and “some of the communications through the state relationships [and] the state public health organizations.”
The plan breaks with the longstanding precedent that CDC distributes vaccines during major outbreaks — such as bad flu seasons — through a centralized ordering system for state and local health officials.
“We believe we’ve actually combined the best of both,” the official said. A second senior administration official stressed the agencies would be working as “one team” to distribute hundreds of millions of doses if any of the vaccines in development are approved in the coming months.
Private companies are also likely to join the effort. The first official said the government is bringing in people to integrate CDC IT capabilities with “some new applications that we’re going to need that the CDC never had.”
The background: The Pentagon will be guiding not just distribution logistics but also manufacturing and “kitting,” the process of safely packaging a vaccine with its necessary equipment such as syringes and needles.
“The DoD is handling all of those logistics — that is where their comparative advantage is,” said the first senior official. “And the CDC, some of their IT systems, relationships with the states following post-vaccination will belong to them.”…
State and local government groups have already raised concerns about Pentagon involvement and using new methods in coronavirus vaccine distribution. The CDC “already leads and maintains a highly effective system of vaccine ordering and distribution,” groups including the Association of State and Territorial Health Officials wrote in June. “With time of the essence we strongly recommend against designing new and untested systems of vaccine distribution.”
The state and local officials also questioned whether military involvement in vaccine administration would undermine already shaky public confidence in vaccines.” (G)
“Executives from four companies in the race to produce a coronavirus vaccine — AstraZeneca, Johnson & Johnson, Moderna Therapeutics and Pfizer — told lawmakers on Tuesday that they are optimistic their products could be ready by the end of 2020 or the beginning of 2021. All four companies are testing vaccines in human clinical trials.
Three of the firms — AstraZeneca, Johnson & Johnson and Moderna — are getting federal funds for their vaccine development efforts. AstraZeneca and Johnson & Johnson pledged to the lawmakers that they would produce hundreds of millions of doses of their vaccines at no profit to themselves. Moderna, however, which has been granted $483 million from the government to develop its product, made no such promise.
“We will not sell it at cost,” said Dr. Stephen Hoge, the president of Moderna.
Many Democratic lawmakers have argued that federal funding for vaccine development should include provisions to guarantee affordability and guard against profiteering.
At the Congressional hearing on Tuesday, some House members raised concerns about Pfizer’s decision to reject federal funds, suggesting it could lead to price-gouging and a lack of transparency… (E)
“On June 26, a small South San Francisco company called Vaxart made a surprise announcement: A coronavirus vaccine it was working on had been selected by the U.S. government to be part of Operation Warp Speed, the flagship federal initiative to quickly develop drugs to combat Covid-19.
Vaxart’s shares soared. Company insiders, who weeks earlier had received stock options worth a few million dollars, saw the value of those awards increase sixfold. And a hedge fund that partly controlled the company walked away with more than $200 million in instant profits.” (F)
“The Serum Institute, which is exclusively controlled by a small and fabulously rich Indian family and started out years ago as a horse farm, is doing what a few other companies in the race for a vaccine are doing: mass-producing hundreds of millions of doses of a vaccine candidate that is still in trials and might not even work.
But if it does, Adar Poonawalla, Serum’s chief executive and the only child of the company’s founder, will become one of the most tugged-at men in the world. He will have on hand what everyone wants, possibly in greater quantities before anyone else.
His company, which has teamed up with the Oxford scientists developing the vaccine, was one of the first to boldly announce, in April, that it was going to mass-produce a vaccine before clinical trials even ended. Now, Mr. Poonawalla’s fastest vaccine assembly lines are being readied to crank out 500 doses each minute, and his phone rings endlessly.
National health ministers, prime ministers and other heads of state (he wouldn’t say who) and friends he hasn’t heard from in years have been calling him, he said, begging for the first batches.
“I’ve had to explain to them that, ‘Look I can’t just give it to you like this,’” he said.
With the coronavirus pandemic turning the world upside down and all hopes pinned on a vaccine, the Serum Institute finds itself in the middle of an extremely competitive and murky endeavor. To get the vaccine out as soon as possible, vaccine developers say they need Serum’s mammoth assembly lines — each year, it churns out 1.5 billion doses of other vaccines, mostly for poor countries, more than any other company…
But right now it’s not entirely clear how much of the coronavirus vaccine that Serum will mass-produce will be kept by India or who will fund its production, leaving the Poonawallas to navigate a torrent of cross-pressures, political, financial, external and domestic.
India has been walloped by the coronavirus, and with 1.3 billion people, it needs vaccine doses as much as anywhere. It’s also led by a highly nationalistic prime minister, Narendra Modi, whose government has already blocked exports of drugs that were believed to help treat Covid-19, the disease caused by the coronavirus.
Adar Poonawalla, 39, says that he will split the hundreds of millions of vaccine doses he produces 50-50 between India and the rest of the world, with a focus on poorer countries, and that Mr. Modi’s government has not objected to this.” (J)
“First we have to look at the global level. The private sector is really driving the vaccine development process, rather than government or academic labs. Major efforts are underway to figure out how private industrial developers can make vaccines available at an affordable price to all countries, particularly low and middle-income countries. It’s a bit like the ventilator supply situation we’ve all faced, but on steroids. Initially there will be scarce supply of the vaccine, governments will be scrambling to procure it, and, unless these efforts work, the winners will be fairly predictable: countries that have the resources.
On the next level, some wealthy countries will likely end up with substantial amounts of vaccine. Over time, if all goes well, these countries will have to decide how much product they’re going to keep and how much, if any, they’re willing to share with other countries where the vaccine may be in very short supply. These are complex questions of ethics, and they’re wrapped up in geopolitics, and also national politics.
There’s a term called vaccine nationalism—where countries understand their obligations to be primarily, if not exclusively, to their own residents. Although there is an expectation that countries with the resources and production capacity will meet their own health needs first, should they ignore the needs of people living in other countries with severe economic constraints? From an ethics perspective, a balance must be struck.” (K)
“As soon as the first COVID-19 vaccines get approved, a staggering global need will confront limited supplies. Many health experts say it’s clear who should get the first shots: health care workers around the world, then people at a higher risk of severe disease, then those in areas where the disease is spreading rapidly, and finally, the rest of us. Such a strategy “saves the most lives and slows transmission the fastest,” says Christopher Elias, who heads the Bill & Melinda Gates Foundation’s Global Development Division. “It would be ludicrous if low-risk people in rich countries get the vaccine when health care workers in South Africa don’t,” adds Ellen ‘t Hoen, a Dutch lawyer and public health activist.
Yet money and national interest may win out. The United States and Europe are placing advance orders for hundreds of millions of doses of successful vaccines, potentially leaving little for poorer parts of the world. “I’m very concerned,” says John Nkengasong, director of the Africa Centres for Disease Control and Prevention.
To avoid such a scenario, the World Health Organization and other international organizations have set up a system to accelerate and equitably distribute vaccines, the COVID-19 Vaccines Global Access (COVAX) Facility, which seeks to entice rich countries to sign on by reducing their own risk that they’re betting on the wrong vaccine candidates. But the idea has been put together on the fly, and it’s unclear how many rich countries will join.” (L)
“As scientists and pharmaceutical companies work at breakneck speed to develop a vaccine for the novel coronavirus, public health officials and senior U.S. lawmakers are sounding alarms about the Trump administration’s lack of planning for its nationwide distribution.
The federal government traditionally plays a principal role in funding and overseeing the manufacturing and distribution of new vaccines, which often draw on scarce ingredients and need to be made, stored and transported carefully.
There won’t be enough vaccine for all 330 million Americans right away, so the government also has a role in deciding who gets it first, and in educating a vaccine-wary here public about its potential life saving merits.
Right now, it is unclear who in Washington is in charge of oversight, much less any critical details, some state health officials and members of Congress told Reuters…
Health officials and lawmakers say they worry that without thorough planning and coordination with states, the vaccine distribution could be saddled with the same sort of disruptions that led to chronic shortages of coronavirus diagnostic tests and other medical supplies…
Some state public health officials, meanwhile, say their entreaties to the Trump administration have been unanswered.
“We have not heard anything from the federal government since April 23,” Danielle Koenig, health promotion supervisor for the Washington State Department of Health, said in an email.
That is when her agency received preliminary guidance on vaccine planning from the CDC.
Immunization experts along with state and local public health officials sent a letter here to Operation Warp Speed on June 23 pleading for fresh guidance.
States need to know promptly if the federal government will pay for the vaccines, as it did during the H1N1 outbreak in 2009, the letter says. Will alcohol swabs, syringes and personal protective equipment be included? What about record-keeping and refrigeration to store the vaccine and who will deliver it?
So far, there’s been no official response, said Claire Hannan, executive director of the Association of Immunization Managers, one of four organizations that signed the letter.
“We urgently await federal, state and local collaborative discussions to identify challenges and plan solutions. A vaccination campaign of this magnitude is unprecedented and it’s going to take more than an army,” Hannan said on Tuesday, referring to Trump’s repeated statements that the U.S. military stands ready to deliver vaccines.
Trump insists everything is in place.
“We’re all set to march when it comes to the vaccine,” Trump said at a White House briefing on Thursday. “… And the delivery system is all set. Logistically we have a general that’s all he does is deliver things whether it is soldiers or other items.
“We are way ahead on vaccines, way ahead on therapeutics and when we have it we are all set with our platforms to deliver them very, very quickly,” Trump said. (M)
PART 1. January 21, 2020. CORONAVIRUS. “The Centers for Disease Control and Prevention on Tuesday confirmed the first U.S. case of a deadly new coronavirus that has killed six people in China.”
PART 2. January 29, 2020. CORONAVIRUS. “If it’s not contained shortly, I think we are looking at a pandemic..”….. “With isolated cases of the dangerous new coronavirus cropping up in a number of states, public health officials say it is only a matter of time before the virus appears in New York City.”
PART3. February 3, 2020. “The Wuhan coronavirus spreading from China is now likely to become a pandemic that circles the globe…”..Trump appeared to downplay concerns about the flu-like virus …We’re gonna see what happens, but we did shut it down..” (D)
PART 4. February 9, 2020. Coronavirus. “A study published Friday in JAMA found that 41% of the first 138 patients diagnosed at one hospital in Wuhan, China, were presumed to be infected in that hospital.….
PART 5. February 12, 2020. CORONAVIRUS. “In short, shoe-leather public health and basic medical care—not miracle drugs—are generally what stop outbreaks of emerging infections..”
POST 6. February 18, 2020. Coronovirus. “Amid assurances that the (ocean liner) Westerdam was disease free, hundreds of people disembarked in Cambodia…” “ One was later found to be infected”…. “Over 1,000… passengers were in…transit home”…. “This could be a turning point””
PART 7. February 20, 2020. CORONAVIRUS. With SARS preparedness underway in NJ LibertyHealth/ Jersey City Medical Center, where I was President, proposed that our 100 bed community hospital with all single-bedded rooms, be immediately transformed into an EMERGENCY SARS ISOLATION Hospital.
PART 8. February 24, 2020. CORONAVIRUS. “…every country’s top priority should be to protect its health care workers. This is partly to ensure that hospitals themselves do not become sites where the coronavirus is spread more than it is contained.”
PART 9. February 27, 2020. CORONAVIRUS. Responding to a question about the likelihood of a U.S. outbreak, President Trump said, “I don’t think it’s inevitable…”It probably will. It possibly will,” he continued. “It could be at a very small level, or it could be at a larger level.”
Part 10. March 1, 2020. CORONAVIRUS. Stop Surprise Medical Bills for Coronavirus care. (&) Lessons Learned (or not) In California and Washington State from community acquired cases.
PART 11. March 5, 2020. CORONAVIRUS. “Gov. Andrew Cuomo… would require employers to pay workers and protect their jobs if they are quarantined because of the coronavirus.”
Part 12. March 10, 2020. CORONAVIRUS. “Tom Bossert, Donald Trump’s former homeland security advisor…(said) that due to the coronavirus outbreak, “We are 10 days from the hospitals getting creamed.”
Part 13.. March 14, 2020. CORONAVIRUS. “If I’m buying real estate in New York, I’ll listen to the President….If I’m asking about infectious diseases, I’m going to listen to Tony Fauci,”
PART 14. March 17, 2020. CORONAVIRUS. “ “Most physicians have never seen this level of angst and anxiety in their careers”…. One said “I am sort of a pariah in my family.”
PART 15. March 22, 2020. CORONAVIRUS. “…Crimson Contagion” and imagining an influenza pandemic, was simulated by the Trump administration….in a series of exercises that ran from last January to August.
PART 16. March 27, 2020. CORONAVIRUS. I am not a clinician or a medical ethicist but articles on Coronavirus patient triage started me Googling………to learn about FUTILE TREATMENT
PART 17. April 2, 2020. CORONAVIRUS. Florida allows churches to continue holding services. Gun stores deemed “essential.” “New York’s private and public hospitals unite to manage patient load and share resources.
PART 18. April 9, 2020. CORONAVIRUS. “The federal government’s emergency stockpile of personal protective equipment (PPE) is depleted, and states will not be receiving any more shipments, administration staff told a House panel.
PART 19. April 13, 2020 CORONOAVIRUS. “…overlooked in the United States’ halting mobilization against the novel coronavirus: the personal aides, hospice attendants, nurses and occupational or physical therapists who deliver medical or support services to patients in their homes.”
POST 22. April 29, 2020. CORONAVIRUS. ..the “ACS released a list of 10 issues that should be addressed before a healthcare organization resumes elective surgeries[JM1] ….”
POST 23. May 3, 2020. CORONAVIRUS. … what Dr. Fauci really wants,…”is just to go to a baseball game. That will have to wait. The level of testing for the virus is not adequate enough to allow for such mass gatherings.’ (K)
POST 24. May 7, 2020. CORONAVIRUS. Former New Jersey governor Chris Christie said: “there are going to be deaths no matter what”… but that people needed to get back to work.
POST 25. May 10, 2020, CORONAVIRUS. “It is scary to go to work,” said Kevin Hassett, a top economic adviser to the president. “I think that I’d be a lot safer if I was sitting at home than I would be going to the West Wing.”
POST 26. May 14, 2020. CORONAVIRUS, “Deep cleaning is not a scientific concept”….”there is no universal protocol for a “deep clean” to eradicate the coronavirus”
POST 27. May 19, 2020. CORONAVIRUS. “Hospital…executives…are taking pay cuts…to help offset the financial fallout from COVID-19.” As “front line” layoffs and furloughs accelerate…
POST 28. May 23, 2020. CORONAVIRUS. ““You’ve got to be kidding me,”..”How could the CDC make that mistake? This is a mess.” CDC conflates viral and antibody tests numbers.
PART 29. May 22, 2020. CORONAVIRUS. “The economy did not close down. It closed down for people who, frankly, had the luxury of staying home,” (Governor Cuomo). But not so for frontline workers!
POST 30. June 3,202. CORONAVIRUS. “The wave of mass protests across the United States will almost certainly set off new chains of infection for the novel coronavirus, experts say….
Post 32. June 16, 2020. CORONAVIRUS. Could the Trump administration be pursuing herd immunity by “inaction”? “ If Fauci didn’t exist, we’d have to invent him.”
POST 34. June 26, 2020. CORONAVIRUS. CDC Director Redfield… “the number of coronavirus infections…could be 10 times higher than the confirmed case count — a total of more than 20 million.” As Florida, Texas and Arizona become eipicenters!
POST 35. June 29, 2020. CORONAVIRUS. Pence: “We slowed the spread. We flattened the curve. We saved lives..” While Dr. Fauci “warned that outbreaks in the South and West could engulf the country…”
POST 36. July 2, 2020. CORONAVIRUS. “There’s just a handful of interventions proven to curb the spread of the coronavirus. One of them is contact tracing, and “it’s not going well,” (Dr. Anthony Fauci)..
POST 37. June 8, 2020. CORONAVIRUS. When “crews arrive at a hospital with a patient suspected of having COVID-19, the hospital may have a physical bed open for them, but not enough nurses or doctors to staff it.”
POST 38. July 15, 2020. CORONAVIRUS. Some Lessons Learned, or not. AdventHealth CEO Terry Shaw: I wouldn’t hesitate to go to Disney as a healthcare CEO — based on the fact that they’re working extremely hard to keep people safe,” (M)
POST 39. July, 23,2020. CORONAVIRUS. A Tale of Two Cities. Seattle becomes New York (rolls back reopening) while New York becomes Seattle (moves to partial phase 4 reopening)
POST 40. July 27, 2020. CORONAVIRUS.” One canon of medical practice is that you order a test only if you can act on the result. And with a turnaround time of a week or two, you cannot. What we have now is often not testing — it’s testing theater.”
POST 41. August 2, 2020. CORONAVIRUS. “Whenever a vaccine for the coronavirus becomes available, one thing is virtually certain: There won’t be enough to go around. That means there will be rationing.”
“MLB and the NBA are getting coronavirus test results quickly and frequently. Some say that’s a problem in places where the results are sometimes so slow that they are worthless.”
to read POSTS 1-40 in chronological order, highlight and click on
“Any stimulus should be directed at the root cause of our recession: dealing with Covid. I know it isn’t popular to talk about in some Republican circles, but we still have a testing problem in this country. My son was tested recently; we had to wait 5 to 7 days for results. My daughter wanted to get tested before visiting her grandparents, but was told she didn’t qualify. That is simply inexcusable at this point in the pandemic.” Former White House Chief of Staff Mick Mulvaney. (P)
“President Trump has used increased coronavirus testing as an explanation for the surge in case counts across the U.S.
“If we didn’t test, you wouldn’t be able to show that chart,” Trump said in response to a question from Chris Wallace about rising U.S. Covid-19 cases in a Fox News interview that aired on July 19. “If we tested half as much, those numbers would be down.”
But a CNBC analysis of testing data found that even as the U.S. has increased its testing capacity, cases of the virus are being found at a higher rate, a pattern that contradicts what epidemiologists say should be happening as a country gets a pandemic under control.
“That claim is patently false,” said Dr. Yonatan Grad, a professor of immunology and infectious diseases at Harvard, in response to the idea that increased testing explains the recent outbreak. “It is at best misleading, and at worst intentionally subverting public health responses.”
In interviews with CNBC, epidemiologists pointed to the “percentage of positive tests” as a way to understand whether the growth in U.S. coronavirus cases is due solely to increased testing. When coronavirus tests are in short supply, only the sickest individuals are typically tested, causing the share of positive tests out of total tests to be high. But as more tests become available, those with mild or no symptoms — who are less likely to have Covid-19 — are able to get tests, which would lead to a lower positivity rate if the virus were not spreading.
The percentage of positive tests in the U.S. has increased from 5.4% on Memorial Day to 8.6% on July 23, according to a CNBC analysis of data from the Covid Tracking Project. Daily testing nationwide has nearly doubled over that period, from an average of 410,000 daily tests performed on May 25 to more than 775,000 daily tests as of July 23. To account for daily reporting fluctuations, CNBC’s analysis used a seven-day average of cases and tests to calculate percent positive rates…
“If the disease was not spreading and you were increasing testing, then the fraction positive should stay stable or go down,” Dr. Grad told CNBC. “But in fact we’re seeing that the fraction of tests that are positive is going up as testing is going up. That is a clear indication that there is increasing spread of the virus.” (R)
“Lines for coronavirus tests have stretched around city blocks and tests ran out altogether in at least one site on Monday, new evidence that the country is still struggling to create a sufficient testing system months into its battle with Covid-19.
At a testing site in New Orleans, a line formed at dawn. But city officials ran out of tests five minutes after the doors opened at 8 a.m., and many people had to be turned away.
In Phoenix, where temperatures have topped 100 degrees, residents have waited in cars for as long as eight hours to get tested.
And in San Antonio and other large cities with mounting caseloads of the virus, officials have reluctantly announced new limits to testing: The demand has grown too great, they say, so only people showing symptoms may now be tested — a return to restrictions that were in place in many parts of the country during earlier days of the virus.
“It’s terrifying, and clearly an evidence of a failure of the system,” said Dr. Morgan Katz, an infectious disease expert at Johns Hopkins Hospital.
In the early months of the nation’s outbreak, testing posed a significant problem, as supplies fell far short and officials raced to understand how to best handle the virus. Since then, the United States has vastly ramped up its testing capability, conducting nearly 15 million tests in June, about three times as many as it had in April. But in recent weeks, as cases have surged in many states, the demand for testing has soared, surpassing capacity and creating a new testing crisis.
In many cities, officials said a combination of factors was now fueling the problem: a shortage of certain supplies, backlogs at laboratories that process the tests, and skyrocketing growth of the virus as cases climb in almost 40 states and the nation approaches a grim new milestone of three million total cases.
Fast, widely available testing is crucial to controlling the virus over the long term in the United States, experts say, particularly as the country reopens. With a virus that can spread through asymptomatic people, screening large numbers of people is seen as essential to identifying those who are carrying the virus and helping stop them from spreading it to others….
Many places have been able to overcome some of the supply constraints that defined the earlier days of the outbreak, in part with their own resources. New York City, once faced with severe shortages as an epicenter of the virus, is now testing 30,000 people a day, officials say, an expansion that included the city building its own testing kits and partnering with private labs.
But even as Gov. Andrew M. Cuomo announced last week that anyone in New York State who wanted a test could get one, officials in other states have been left seeking a more robust testing system, and setting new limits on who can take one.
“We are too fragmented,” said Dr. Michael Mina, an assistant professor of epidemiology at Harvard’s T.H. Chan School of Public Health. “We don’t have a good way to load-balance the system.”” (A)
“The number of people infected with the coronavirus in different parts of the United States was anywhere from two to 13 times higher than the reported rates for those regions, according to data released Tuesday by the Centers for Disease Control and Prevention.
The findings suggest that large numbers of people who did not have symptoms or did not seek medical care may have kept the virus circulating in their communities.
The study indicates that even the hardest-hit area in the study — New York City, where nearly one in four people has been exposed to the virus — is nowhere near achieving herd immunity, the level of exposure at which the virus would stop spreading in a particular city or region. Experts believe 60 percent of people in an area would need to have been exposed to the coronavirus to reach herd immunity.
The analysis, based on antibody tests, is the largest of its kind to date; a study of a subset of cities and states was released last month.
“These data continue to show that the number of people who have been infected with the virus that causes Covid-19 far exceeds the number of reported cases,” said Dr. Fiona Havers, the C.D.C. researcher who led the study. “Many of these people likely had no symptoms or mild illness and may have had no idea that they were infected.”
About 40 percent of infected people do not develop symptoms, but they may still pass the virus on to others. The United States now tests roughly 700,000 people a day. The new results highlight the need for much more testing to detect infection levels and contain the viral spread in various parts of the country.” (B)
“The director of the National Institutes for Health said on Sunday that long delays Americans are seeing across the country in getting coronavirus test results is undercutting their usefulness.
“The average test delay is too long,” Dr. Francis Collins said Sunday on NBC’s “Meet the Press.” “And that really undercuts the value of the testing, because you do the testing to find out who’s carrying the virus and then quickly get them isolated so they don’t spread it around.”
As Covid-19 continues to surge in the US, some states, labs and public health departments are warning that turnaround times for diagnostic testing have slowed.
The challenges, which stem in part from persistent obstacles in the test supply chain, underscore that while overall US testing capacity has multiplied, the nation’s health system still struggles in some regions to rapidly detect the spread of the virus.
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Despite federal efforts to support testing in some cities and regions, major diagnostic companies said earlier this month that the growing demand for tests has in turn increased average wait times for delivering results. CNN previously reported results can now take an average of four to six days for the general population or in some states like Arizona up to three weeks.
Collins said Sunday that the government must invest in new technologies in order to keep up with the testing demand.” (C)
“Health workers typically advise their patients to quarantine at home while they await their test results, out of an abundance of caution. To the extent that one can, “The best thing to do is to act as if you’ve been infected” in this interim period, said Olivia Prosper, an infectious disease modeler at the University of Tennessee, Knoxville. But the longer people are forced to wait, the more difficult that advice is to follow — and the larger toll their absence from work or family responsibilities can take.
Additionally, negative results can be of little use if they are delivered after too long of a delay. Diagnostic testing, which searches for bits of the coronavirus’s genetic material, can only assess a person’s health status from the time the sample was taken, and can’t account for any subsequent exposures to the virus.
Some have held out hope that new, confirmed coronavirus cases could soon peak in certain states, after which parts of the nation might experience a much-needed respite in infections — as, perhaps, some regions did for much of May. But the duration of that apex, which might actually manifest more like a plateau, can’t be definitively forecast. With many laboratories stretched to or past their limits, a leveling-off in confirmed cases could indicate a slowing in the coronavirus’s spread. Or it could simply reflect a regional ceiling in testing capacity.” (D)
“Testing that takes five days or longer is of little use, researchers from the University of Utrecht in the Netherlands reported Thursday in the journal Lancet Public Health.
“In our model, minimizing testing delays had the largest impact on reducing transmission of the virus and testing infrastructure is therefore the most critical factor for the success of a contact tracing system,” Marc Bonten, who helped lead the study, said in a statement.
Contact tracing is considered the gold standard for fighting an epidemic of infectious disease, but it requires testing all people who may be infected, isolating those who are, and then tracking down other people they may have infected and testing and isolating or quarantining them.
For these efforts to actually reduce the spread of the virus, three things need to happen, the researchers said. First, testing must happen on the day a person develops symptoms. Second, contacts must be traced starting the day test results come back. And third, there needs to be 100% tracing coverage.
With a testing delay of more than three days, not even perfect contact tracing could keep the spread of the virus from accelerating.
The researchers considered both conventional and app-based contact tracing methods. Because of their speed, app-based tracing methods were more effective than conventional methods, even with lower contact coverage.
In fact, app technology could keep the viral spread from accelerating even with a delay of up to two days, as long as there was 80% testing and tracing coverage.
Once the testing delay goes over to five or more days, app tracing “adds little effectiveness to conventional contact tracing or just isolation of symptomatic cases,” the researchers wrote.
“This study reinforces findings from other modelling studies, showing that contact tracing can be an effective intervention to prevent spread of the SARS-CoV-2 virus, but only if the proportion of contacts traced is high and the process is fast. “ (E)
“Quest Diagnostics, one of the companies performing a significant amount of the coronavirus testing in the U.S., said Monday that its average turnaround time for test results is at least seven days for most patients.
The announcement illustrates how the spike in coronavirus cases is overwhelming the country’s testing capacity.
The company said Monday that its average time to get coronavirus test results back is now “7 or more days” for everyone except the highest-priority patients, meaning people who are hospitalized or symptomatic health care workers.
Quest said the lagging turnaround times are due to “soaring demand” for coronavirus testing that is overwhelming the company’s capacity.
The rise in demand comes as coronavirus cases are surging in many regions across the country.
“We attribute this demand primarily to the rapid, continuing spread of COVID-19 infections across the nation but particularly in the South, Southwest and West regions of the country,” the company said.
Such long turnaround times greatly hinder the country’s response to the virus by reducing the ability to do contact tracing to identify and warn people who have been in contact with an infected person to cut off further transmission.
With waits this long, someone could unknowingly continue to spread the virus for days after getting tested but before getting their results.
The long turnaround times are not limited to Quest. The American Clinical Laboratory Association, which represents a wide range of commercial labs, warned at the end of June that the “significant increase in demand could extend turnaround times for test results.”” (F)
“The U.S. is testing over 700,000 people per day, up from less than 100,000 in March. Trump administration officials point out that roughly half of U.S. tests are performed on rapid systems that give results in about 15 minutes or in hospitals, which typically process tests in about 24 hours. But last month, that still left some 9 million tests going through laboratories, which have been plagued by limited chemicals, machines and kits to develop COVID-19 tests.
There is no scientific consensus on the rate of testing needed to control the virus in the U.S., which has the most cases and deaths of any nation. But experts have recommended for months that the U.S. test at least 1 million to 3 million people daily.
Health experts assembled by the Rockefeller Foundation said last week that the U.S. should scale up to testing 30 million Americans per week by the fall, when school reopenings and flu season are expected to further exacerbate the virus’ spread. The group acknowledged that their figure will not be possible with the current laboratory-based testing system.
The National Institutes of Health has set up a “shark tank” competition to quickly identify promising rapid tests and has received more than 600 applications. The goal is to have new testing options in mass production by the fall.
Until then, the the backbone of U.S. testing remains at several hundred labs with high-capacity machines capable of processing thousands of samples per day. Many say they could be processing far more tests if not for global shortages of testing chemicals, pipettes and other materials.
Dr. Bobbi Pritt of the Mayo Clinic in Rochester, Minnesota, says the hospital’s machines are running at just 20% of capacity. Lab technicians run seven different COVID-19 testing formats, switching back and forth depending on the availability of supplies.
At Emory University Hospital in Atlanta, lab workers lobby testing manufacturers on a weekly basis to provide more kits, chemicals and other materials.
“There’s no planning ahead, we just do as many as we can and cross our fingers that we’ll get more,” said Dr. Colleen Kraft, who heads the hospital’s testing lab.” (G)
“Atrium Health is processing coronavirus tests at just 20% to 25% of its capacity due to a national shortage of the chemicals needed to run the test, the Charlotte-based company’s president told a U.S. Senate panel Tuesday.
Gene Woods, president and CEO of the not-for-profit system, said Atrium can handle 4,000 coronavirus tests per day with its in-house lab equipment. But they are processing far less than that, he said, “due to the national supply shortage in reagents.”
Reagents are chemicals used in a reaction to detect a substance and are needed in COVID-19 testing to get a positive or negative result.
“We could probably do four times the amount of tests and have close to same-day turnaround, the challenge is reagents and, still in some respects, swabs,” Woods said. “We really need to continue to beef up the supplies of reagents so that we can expedite the testing. That would be our request.”
Nearly five months after the first lab-confirmed coronavirus case in North Carolina, the state is again dealing with long wait times for test results.
The average turnaround time is now closer to six or seven days, said Dr. Mandy Cohen, the state’s top health official. That turnaround time was two or three days in June.
Mecklenburg County Public Health Director Gibbie Harris said the turnaround time in the county is five to 10 days.” (H)
“Minnesota health officials are worried the state’s robust coronavirus testing capacity could be hampered by an increasingly stressed international medical supply chain.
Just a few weeks ago, Minnesotans were able to get the results of their coronavirus tests within about 24 hours. But now, the wait can be three days or more, delaying when contact tracers can begin investigating new infections.
“Health officials worry the ongoing national spike in cases could further impact Minnesota’s ability to screen for COVID-19 infections and return results quickly. Minnesota has screened on average about 12,000 samples per day since June 1 and is steadily approaching administering 1 million tests since the outbreak began.
The state currently has about 50,000 laboratory-confirmed cases and more than 1,560 COVID-19 deaths.
In some of the hardest hit parts of the U.S., test results can take a week or more — leaving Minnesota officials concerned about what may be on the horizon if supply chains don’t improve. Quick and precise testing is a key way to fight the virus by isolating positive patients so they cannot infect others.
“The faster the turnaround the better,” said Jan Malcolm, Minnesota’s health commissioner. “We are concerned this does have the potential to interfere with our testing capacity.”
Much of Minnesota’s ability to screen for the virus is based on a partnership between the state Department of Health, the Mayo Clinic, the University of Minnesota and other health care providers. Both the Mayo Clinic and M Health Fairview are reporting wait times for results of about three days.
“Unfortunately, Mayo Clinic is not immune to the shortages we have been seeing nationwide,” said Dr. Bobbi Pritt, a professor of clinical microbiology at the Mayo Clinic. “Some of these big manufacturers, with commonly used tests, are not able to deliver what they had agreed to deliver.”…
Dr. Pritt says there already are worrisome national shortages on materials needed to process COVID-19 tests. Large medical suppliers like Roche, Abbott and Hologic rely on the same supply chains to manufacture products and they are swamped with rising demand as cases surge in the U.S. and parts of the world.” (S)
“A recent article by my colleague Keith Collins found that California is one of 34 states that are currently not testing enough and that the state is 34 percent of the level that researchers at the Harvard Global Health Institute deemed necessary to mitigate the spread of the virus. By comparison, Vermont and Connecticut are way above, testing over 400 percent of the level above the target set by researchers. Arizona, Florida and Texas make up the bottom three.
And now, backlogs are causing delays in getting test results, so state officials have released new, stricter testing guidelines that will make it much tougher for many Californians who don’t have symptoms to get tested.
To understand how California’s testing performance matches up against other states, I asked Keith, a graphics editor, some questions about his findings and what it means for the Golden State.
According to your article, California is one of 34 states that you found to be below the testing target. What exactly does that mean, and what are the implications?
So California is pretty tricky because it’s so big. It’s in the top 10 in terms of daily tests per 100,000 people, which is pretty good, especially for a state its size. Unfortunately with testing, there’s not a lot of data that’s more granular than the state level so it’s hard to say where in the state testing is the worst.
In terms of the number of people it’s testing every day, it’s doing pretty well. But in terms of the target that Harvard has set as the minimum that a place needs to be doing to mitigate the virus, it’s way behind. It’s only doing 34 percent of that target right now.
How did researchers come up with the target goals in this model?
It’s based on the idea that anyone who has symptoms should be tested and then for anyone who tests positive, 10 of their contacts should also be tested. The idea is that you can’t really have a safe reopening if you’re not able to keep everyone who is sick isolated and that includes people who are asymptomatic. And right now a lot of places are just not testing people who are asymptomatic, at least not in a very concerted way.
These targets try to estimate how many tests you would need to do every day if you were going to identify nearly everyone who has the virus. And that’s going to include a lot of people who are not currently being tested right now.
It looks like there are currently 11 states, including New York, Hawaii and Massachusetts, that are currently meeting their target and six others that are close.
In the article’s charts you can see that a lot of those states only got to that level recently and some of those are trending downward again. Those charts are relative to the target so it can also mean that the target is rising and testing is steady. But New York and New Jersey really ramped up testing because they were hit so hard in the beginning. Still, only in early to mid-June have they started really catching up to that target.
It is a hard target to hit, but it is a conservative estimate. The Harvard researchers say that this target is really just to mitigate the spread of the virus. They have another estimate to suppress the virus. Their suppression target is way higher than this.” (I)
“The U.S. Food and Drug Administration on Saturday gave emergency use authorization to a coronavirus testing method that could massively ramp up testing capabilities for the country.
The FDA is allowing Quest Diagnostics to test individual samples for coronavirus using a method known as batch testing, which mixes specimens from multiple people and tests the combined sample for coronavirus instead of testing samples one by one.” (J)
“Samples scraped from the back of patients’ noses and throats can now be bundled together and tested for the coronavirus in groups in one of the country’s biggest commercial labs. Quest Diagnostics, which handles tens of thousands of coronavirus tests each day, received authorization for the method, called pooled testing, from the Food and Drug Administration over the weekend.
The strategy helps conserve resources by running multiple tests using the materials usually required for one. It could also help Quest avoid backlogs and move testing along more quickly. Right now, demand for testing is so high that it takes an average of seven days for Quest labs to get results to patients.
However, the strategy can’t clear all testing roadblocks, and it may not work as well in the areas where it’s most needed: outbreak hotspots, where testing resources are stretched the thinnest. In those environments, where a high percentage of tests turn out to be positive, pools don’t end up saving materials — too many are positive, which means more retesting.
“When the positivity rate is high, pooling is not very effective, because you’re splitting apart way too many pools, and it’s just not worth your effort,” says Peter Iwen, director of the Nebraska Public Health Laboratory…
Pooling also doesn’t help once the rate of infections in a community starts ticking up. Iwen had to stop using pooled testing in the Nebraska lab a few weeks back because the percentage of tests that came back positive was too high — above 10 percent. In any random group of four or five tests, there was a high chance that one would be positive. If the positive rate is that high, pooling doesn’t tend to save a significant amount of chemicals or time.
The new instructions for the Quest pooled testing say that, if 13 percent of tests done at a lab are coming back positive, the lab should drop the pool size down to three. If 25 percent of a lab’s tests are coming back positive, they shouldn’t do pooled testing. Virginia and Massachusetts, home to the first Quest labs set to use pooled testing, positivity rate is about 6 and 2 percent, respectively. In Arizona, one of the hardest-hit states, it’s around 24 percent.” (K)
“But what should the Food and Drug Administration do with a rapid test that is comparatively cheap but much less accurate than the tests currently on the market? A test like that is ready to go up for FDA approval, and some scientists argue it could be valuable despite its shortcomings.
At first blush, you wouldn’t want a medical test to be pushing out untrustworthy results. And that’s certainly the case for a medical diagnosis. But rapid test could be valuable if used to screen large numbers of people for infection repeatedly and frequently.
For example, some of the rapid tests under development don’t detect the virus in a person who is in the early or late stages of infection — they only catch an infection at its peak. Dr. Michael Mina at the Harvard T.H. Chan School of Public Health says that’s OK, under certain circumstances.
“As long as you’re using the test on a pretty frequent basis,” Mina says, “you will be more likely than not to catch the person on the day they might go out and transmit. And they’ll know to stay home.”
To be useful, such tests need to be widely available and affordable, he says. “I envision a time when everyone can order a pack of 50 tests for $50 and have those and use them every other day for a couple of months.”
When it comes to controlling the epidemic, that could be an appealing alternative to the current laboratory-based system, an overburdened process that has become a serious bottleneck. These days, some people are waiting a week or more for results, and by then they have potentially spread the virus to others.
Highly accurate at-home tests are probably many months away. But Mina argues they could be here sooner if the FDA would not demand that tests for the coronavirus meet really high accuracy standards of 80 percent or better.” (L)
“The White House is trying to block billions of dollars for coronavirus testing and contact tracing in the upcoming stimulus relief bill, two Republican sources told NBC News, even as infections surge across the country and Americans face long wait times to receive test results amid high demand.
Senate GOP lawmakers, in a break with the administration, are pushing back and trying to keep the money for testing and tracing in the bill, the sources told NBC News. Some White House officials reportedly believe new money shouldn’t be allocated for testing because previous funds remain unspent.
The White House declined CNBC’s request for comment. The Washington Post first reported the news.
The Trump administration also wants to block billions of dollars that would go toward bolstering the Centers for Disease Control and Prevention, the Pentagon and the State Department to combat the pandemic, The Post reported Saturday, citing people familiar with the deliberations.
While moving to block testing assistance, the Trump administration is trying to use the legislation to fund priorities unrelated to the pandemic such as a new FBI building, according to the Post.
The White House effort to block funding for testing comes after the administration relied on overly optimistic models which suggested the U.S. moved past the peak of the outbreak in the spring, according to a report in The New York Times. As a result, the administration pushed to reopen the economy and shifted responsibility for responding to the pandemic from the federal government to the states with disastrous results, according to the Times.
President Trump has called coronavirus testing a “double-edged sword” and suggested at a campaign rally in Tulsa, Oklahoma that officials should slow testing down. White House officials later said Trump was joking.
The Times’ report portrayed a president who feels trapped politically because cases counts inevitably increase as more people are tested, jeopardizing the reopening of the economy and damaging his re-election chances.” (M)
“Nearly four months after the pandemic’s peak, New York City is facing such serious delays in returning coronavirus test results that public health experts are warning that the problems could hinder efforts to reopen the local economy and schools.
Despite repeated pledges from Gov. Andrew M. Cuomo and Mayor Bill de Blasio that testing would be both widely accessible and effective, thousands of New Yorkers have had to wait a week or more for results, and at some clinics the median wait time is nine days. One prominent local official has even proposed the drastic step of limiting testing.
The delays in New York City are caused in part by the outbreak’s spike in states like California, Florida and Texas, which has strained laboratories across the country and touched off a renewed national testing crisis.
But officials have also been unable to adequately expand the capacity of state and city government laboratories in New York to test rapidly at a time when they are asking more New Yorkers to get tested to guard against a second wave.
The delays limit the ability of public health officials to quickly identify — and isolate — people who are infected while also diminishing the usefulness of New York City’s contact-tracing program. They also can lead to growing blind spots that obscure the extent of the virus’s spread, which could spell trouble as the city tries to reopen.
As a result, some public officials and laboratory executives say New York’s strategy of allowing anyone and everyone who wants a test to get one is unsustainable.” (Q)
“Coronavirus testing in the United States has been bungled in every way imaginable. The latest fiasco is perhaps the most Kafka-esque: Tests are now widely available in many places, but results are often taking so long to come back that it is more or less pointless to get tested.
If it takes up to two weeks to get results, we can’t detect brewing outbreaks and respond with targeted shutdowns. We can’t do meaningful contact tracing. We can’t expect people to stay home from work or school for two weeks while they wait for the result of a screen. We have no way to render early treatment and attention to those who test positive, to try to prevent serious illness. It’s a disaster….
Connor Kelley feared he had been exposed to the coronavirus while playing miniature golf at a friend’s birthday party, so he visited a drive-through testing clinic near Orlando, Fla. He was told to expect results in a few days. It took 10 days.
A few miles and hundreds of millions of dollars away, professional athletes are being tested every day. Their results are coming back in less than 24 hours.” (O)
“Federal, state and local officials on Sunday appeared to agree on one thing: Test results are taking too long.
But they gave conflicting assessments of the U.S. response to recent spikes in coronavirus cases, which have severely strained testing nationwide and led to renewed shortages of supplies and weeklong backlogs at major labs.
Adm. Brett Giroir, the assistant health secretary overseeing the national coronavirus testing response, said the country was performing enough testing to “achieve the goals we need to achieve.”
Speaking on CNN’s “State of the Union,” Mr. Giroir acknowledged that turnaround times were too long. But he asserted that while testing was still not widely available to anyone who wanted it — despite past claims from Mr. Trump that it would be — it was available to those who needed it.
Testing is considered crucial to understanding and stopping the spread of the coronavirus. When turnaround times extend beyond several days, it can render the information useless since those tested may have spread the virus to other people by the time their results are back.
Mark Meadows, President Trump’s chief of staff, skirted questions about the administration’s early missteps by suggesting that medical advancements, not masks, would be the only way to end the pandemic. “Hopefully it is American ingenuity that will allow for therapies and vaccines to ultimately conquer this,” he said on the ABC program “This Week.”” (T)
PART 1. January 21, 2020. CORONAVIRUS. “The Centers for Disease Control and Prevention on Tuesday confirmed the first U.S. case of a deadly new coronavirus that has killed six people in China.”
PART 2. January 29, 2020. CORONAVIRUS. “If it’s not contained shortly, I think we are looking at a pandemic..”….. “With isolated cases of the dangerous new coronavirus cropping up in a number of states, public health officials say it is only a matter of time before the virus appears in New York City.”
PART3. February 3, 2020. “The Wuhan coronavirus spreading from China is now likely to become a pandemic that circles the globe…”..Trump appeared to downplay concerns about the flu-like virus …We’re gonna see what happens, but we did shut it down..” (D)
PART 4. February 9, 2020. Coronavirus. “A study published Friday in JAMA found that 41% of the first 138 patients diagnosed at one hospital in Wuhan, China, were presumed to be infected in that hospital.….
PART 5. February 12, 2020. CORONAVIRUS. “In short, shoe-leather public health and basic medical care—not miracle drugs—are generally what stop outbreaks of emerging infections..”
POST 6. February 18, 2020. Coronovirus. “Amid assurances that the (ocean liner) Westerdam was disease free, hundreds of people disembarked in Cambodia…” “ One was later found to be infected”…. “Over 1,000… passengers were in…transit home”…. “This could be a turning point””
PART 7. February 20, 2020. CORONAVIRUS. With SARS preparedness underway in NJ LibertyHealth/ Jersey City Medical Center, where I was President, proposed that our 100 bed community hospital with all single-bedded rooms, be immediately transformed into an EMERGENCY SARS ISOLATION Hospital.
PART 8. February 24, 2020. CORONAVIRUS. “…every country’s top priority should be to protect its health care workers. This is partly to ensure that hospitals themselves do not become sites where the coronavirus is spread more than it is contained.”
PART 9. February 27, 2020. CORONAVIRUS. Responding to a question about the likelihood of a U.S. outbreak, President Trump said, “I don’t think it’s inevitable…”It probably will. It possibly will,” he continued. “It could be at a very small level, or it could be at a larger level.”
Part 10. March 1, 2020. CORONAVIRUS. Stop Surprise Medical Bills for Coronavirus care. (&) Lessons Learned (or not) In California and Washington State from community acquired cases.
PART 11. March 5, 2020. CORONAVIRUS. “Gov. Andrew Cuomo… would require employers to pay workers and protect their jobs if they are quarantined because of the coronavirus.”
Part 12. March 10, 2020. CORONAVIRUS. “Tom Bossert, Donald Trump’s former homeland security advisor…(said) that due to the coronavirus outbreak, “We are 10 days from the hospitals getting creamed.”
Part 13.. March 14, 2020. CORONAVIRUS. “If I’m buying real estate in New York, I’ll listen to the President….If I’m asking about infectious diseases, I’m going to listen to Tony Fauci,”
PART 14. March 17, 2020. CORONAVIRUS. “ “Most physicians have never seen this level of angst and anxiety in their careers”…. One said “I am sort of a pariah in my family.”
PART 15. March 22, 2020. CORONAVIRUS. “…Crimson Contagion” and imagining an influenza pandemic, was simulated by the Trump administration….in a series of exercises that ran from last January to August.
PART 16. March 27, 2020. CORONAVIRUS. I am not a clinician or a medical ethicist but articles on Coronavirus patient triage started me Googling………to learn about FUTILE TREATMENT
PART 17. April 2, 2020. CORONAVIRUS. Florida allows churches to continue holding services. Gun stores deemed “essential.” “New York’s private and public hospitals unite to manage patient load and share resources.
PART 18. April 9, 2020. CORONAVIRUS. “The federal government’s emergency stockpile of personal protective equipment (PPE) is depleted, and states will not be receiving any more shipments, administration staff told a House panel.
PART 19. April 13, 2020 CORONOAVIRUS. “…overlooked in the United States’ halting mobilization against the novel coronavirus: the personal aides, hospice attendants, nurses and occupational or physical therapists who deliver medical or support services to patients in their homes.”
POST 22. April 29, 2020. CORONAVIRUS. ..the “ACS released a list of 10 issues that should be addressed before a healthcare organization resumes elective surgeries[JM1] ….”
POST 23. May 3, 2020. CORONAVIRUS. … what Dr. Fauci really wants,…”is just to go to a baseball game. That will have to wait. The level of testing for the virus is not adequate enough to allow for such mass gatherings.’ (K)
POST 24. May 7, 2020. CORONAVIRUS. Former New Jersey governor Chris Christie said: “there are going to be deaths no matter what”… but that people needed to get back to work.
POST 25. May 10, 2020, CORONAVIRUS. “It is scary to go to work,” said Kevin Hassett, a top economic adviser to the president. “I think that I’d be a lot safer if I was sitting at home than I would be going to the West Wing.”
POST 26. May 14, 2020. CORONAVIRUS, “Deep cleaning is not a scientific concept”….”there is no universal protocol for a “deep clean” to eradicate the coronavirus”
POST 27. May 19, 2020. CORONAVIRUS. “Hospital…executives…are taking pay cuts…to help offset the financial fallout from COVID-19.” As “front line” layoffs and furloughs accelerate…
POST 28. May 23, 2020. CORONAVIRUS. ““You’ve got to be kidding me,”..”How could the CDC make that mistake? This is a mess.” CDC conflates viral and antibody tests numbers.
PART 29. May 22, 2020. CORONAVIRUS. “The economy did not close down. It closed down for people who, frankly, had the luxury of staying home,” (Governor Cuomo). But not so for frontline workers!
POST 30. June 3,202. CORONAVIRUS. “The wave of mass protests across the United States will almost certainly set off new chains of infection for the novel coronavirus, experts say….
Post 32. June 16, 2020. CORONAVIRUS. Could the Trump administration be pursuing herd immunity by “inaction”? “ If Fauci didn’t exist, we’d have to invent him.”
POST 34. June 26, 2020. CORONAVIRUS. CDC Director Redfield… “the number of coronavirus infections…could be 10 times higher than the confirmed case count — a total of more than 20 million.” As Florida, Texas and Arizona become eipicenters!
POST 35. June 29, 2020. CORONAVIRUS. Pence: “We slowed the spread. We flattened the curve. We saved lives..” While Dr. Fauci “warned that outbreaks in the South and West could engulf the country…”
POST 36. July 2, 2020. CORONAVIRUS. “There’s just a handful of interventions proven to curb the spread of the coronavirus. One of them is contact tracing, and “it’s not going well,” (Dr. Anthony Fauci)..
POST 37. June 8, 2020. CORONAVIRUS. When “crews arrive at a hospital with a patient suspected of having COVID-19, the hospital may have a physical bed open for them, but not enough nurses or doctors to staff it.”
POST 38. July 15, 2020. CORONAVIRUS. Some Lessons Learned, or not. AdventHealth CEO Terry Shaw: I wouldn’t hesitate to go to Disney as a healthcare CEO — based on the fact that they’re working extremely hard to keep people safe,” (M)
POST 39. July, 23,2020. CORONAVIRUS. A Tale of Two Cities. Seattle becomes New York (rolls back reopening) while New York becomes Seattle (moves to partial phase 4 reopening)
POST 40. July 27, 2020. CORONAVIRUS.” One canon of medical practice is that you order a test only if you can act on the result. And with a turnaround time of a week or two, you cannot. What we have now is often not testing — it’s testing theater.”
