CME: to understand CDC/ FDA/White House discombobulation highlight and click on https://www.youtube.com/watch?v=2ve20PVNZ18
for links to POSTS 1-260 in chronological order highlight and click on
“Fauci says he’s taking 2nd course of Paxlovid after experiencing rebound with the antiviral treatment
Dr. Anthony Fauci, the chief medical adviser to President Joe Biden, was first diagnosed with the virus nearly two weeks ago.
After testing positive for COVID-19 earlier this month, Dr. Anthony Fauci said Tuesday that he has joined a growing group of people experiencing a Paxlovid rebound, following treatment with Pfizer’s antiviral.
Fauci, 81, said that when he first tested positive two weeks ago, he had very minimal symptoms. However, when he began to feel worse, “given [his] age,” he was prescribed Paxlovid.
Other than fatigue and a bit of congestion, Fauci reported that he felt “really quite well,” and after his five-day course of Paxlovid, he tested negative with a rapid test.
However, after testing negative for three consecutive days, Fauci said he decided to take one more test out of precaution and subsequently found himself positive again on the fourth day.
“It was sort of what people are referring to as a Paxlovid rebound,” Fauci said during a remote interview with the Foreign Policy Global Health Forum on Tuesday.
Over the course of the next day, he began to feel “really poorly,” and “much worse than in the first go around,” he added.
Paxlovid is authorized in the U.S. for people with mild-to-moderate symptoms of COVID-19, who are at significant risk of progressing to severe illness.
Last month, the Centers for Disease Control and Prevention asked doctors to be on the lookout for the seemingly rare, but increasingly reported phenomenon…
The Food and Drug Administration also says that “there is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.” (A)
“The phenomenon that Fauci mentioned — also known as COVID-19 rebound — has been acknowledged by the Centers for Disease Control and Prevention. In May, the CDC issued an advisory on the potential recurrence of symptoms and possibly a “new positive viral test after having tested negative” within two to eight days of finishing a five-day course of Paxlovid.
The agency noted, however, that the resurgence of symptoms “may be part of the natural history of SARS-CoV-2 … infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status.”
The CDC added that Paxlovid is still believed to be an effective treatment in the early stages of COVID-19 infection among those at higher risk for severe illness. Still, the agency has not found evidence that a second round of Paxlovid — like the one Fauci is taking — is necessary among those suffering from “COVID-19 rebound.”” (B)
“Dr. Anthony S. Fauci, President Biden’s top medical adviser for the coronavirus pandemic, sought on Wednesday to discourage doubts about the antiviral drug Paxlovid after disclosing that he had suffered what appeared to be a “rebound” of Covid-19 after taking a five-day course of the pills.
“Paxlovid did what it was supposed to do,” Dr. Fauci, 81, said in an interview, saying that he believed that the treatment, made by Pfizer, kept him out of the hospital when he first tested positive for the virus on June 15. He added that he thought the drug also reduced the severity of his initial symptoms…
Dr. Ashish K. Jha, the White House coronavirus coordinator, said on Thursday that the data generally showed that between 2 and 5 percent of patients using Paxlovid experienced a rebound, with some data suggesting a rate as high as 7 to 8 percent.
“We’re not seeing any evidence that rebound leads to people getting super sick and hospitalized,” Dr. Jha said in an interview. While the small minority who see symptoms return or test positive again “should isolate,” he said, “the primary purposes of this treatment is to keep people out of the hospital.” He said Paxlovid was doing a “fantastic job” at that.
The C.D.C. said that Paxlovid “continues to be recommended for early-stage treatment of mild to moderate Covid-19 among persons at high risk for progression to severe disease.” The Food and Drug Administration authorized Paxlovid for high-risk people age 12 and older who weigh at least 88 pounds…
The clinical trial that supported the F.D.A.’s authorization of Paxlovid was conducted in people who were unvaccinated, which has led some experts to say that more data on vaccinated people is needed. Among them is Dr. Carlos del Rio, an infectious disease expert at Emory University, who said in an interview that “we urgently need data to know, in people who are vaccinated and over the age of 65 like Tony, who needs it and for how long.”
Dr. Fauci said he would like to see a study comparing a five-day course of Paxlovid to a 10-day course, “to see if you can prevent the rebound by giving it for five extra days.”…
“I think there is understandable confusion when people hear about people rebounding,” he said. “Don’t confuse that with the original purpose of what Paxlovid is meant for. It’s not meant to prevent you from rebounding. It’s meant to prevent you from being hospitalized. I’m 81 years old, I was at risk for hospitalization and I didn’t even come close to being sick enough to be hospitalized.”” (C)
IT’S ABOUT TIME!
“The Food and Drug Administration added pharmacists on Wednesday to the list of health care professionals who are allowed to prescribe Pfizer’s pills for treating Covid-19. The move, aimed at making it easier for patients to get the drug, will significantly increase the number of prescribers who can order the treatment, known as Paxlovid.
There are more than 300,000 licensed pharmacists across the United States, according to the American Pharmacists Association, a professional group that has been lobbying for the change.
Previously, only doctors, nurses and physician assistants were allowed to prescribe the treatment. That restriction often forced patients to scramble to find a prescriber and then a location that would dispense the pills, which must be taken within five days of the start of symptoms.
The complexity of obtaining Paxlovid has contributed to inequities in who is getting it. Dispensing rates for Paxlovid and a similar treatment from Merck were lowest in the country’s poorest ZIP codes over the first five months when the treatments were available, according to a recent analysis from the Centers for Disease Control and Prevention.
The Biden administration moved earlier this year to expand access to the treatments by launching a “test to treat” program that was intended to allow patients to get a prescription for the pills immediately after testing positive for the virus, and at the same location, often a CVS MinuteClinic. But those clinics required an in-house nurse practitioner or physician assistant to be present to prescribe the drug, and those professionals are not available at many pharmacies…
On Wednesday, the F.D.A. said that Covid patients seeking a prescription for the pills from a pharmacist should bring records of their recent blood tests and a list of the other medications they take. The pharmacist should then review the records for potential kidney or liver problems or problematic interactions between Paxlovid and the patient’s other drugs, the agency said. A component of Pfizer’s treatment can interfere with certain medications, including common ones for cholesterol and cardiovascular issues, potentially causing serious side effects.
The agency said that pharmacists should refer patients to other prescribers if the records and information about other medications was not available.” (D)
“The United States is spending about $530 for each 5-day course of Pfizer’s COVID-19 pill, Paxlovid. But the contract for the first 10 million doses would allow the government to get a lower price if one of a handful of other wealthy countries gets a better deal on the drug.
It’s part of a purchase agreement that seems to be more favorable to the federal government overall compared to the COVID-19 vaccine contracts, says Robin Feldman, a professor at the University of California Hastings College of the Law, who focuses on the pharmaceutical industry and drug policy.
“I think this contract reflects a change in the national mood across time,” she says. “So with vaccines and some treatments on the shelves, the nation is less panicked. U.S. government officials feel less backed into a corner, more able to negotiate. “
The contract includes a buyback clause, meaning that in the event that Paxlovid’s emergency use authorization needs to be withdrawn, Pfizer would buy back unexpired treatment courses from the federal government…
The original contract, dated Nov. 17, 2021, lays out a product release schedule with most of the doses coming in the spring and summer of 2022. Indeed more than half are expected in the last two months of the 10-month contract period.
It shows how Pfizer is still scaling up production of Paxlovid. In December, it only expected to release 50,000 courses. But in March, it expected 400,000. And in September, it expected to release 3.25 million courses.
Since this contract was signed, Pfizer and the government have moved up the production targets and doubled the order to 20 million treatment courses. So the 10 million treatments that were slated for delivery by September are supposed to arrive by the end of June. The additional 10 million treatments are due by the end of September.
The Biden administration did not respond to NPR’s questions around how this will impact the original release schedule.
Pfizer declined to comment on the specifics in the contract, but said it started getting its Paxlovid supply chain and manufacturing preparation underway in early 2021.
“We’re constantly looking to improve our processes, timelines and expand the supply chain – including scaling up our internal and external network, raw material production and tableting capacity,” Pfizer spokesperson Steven Danehy told NPR in an email. “Through this work we have already increased our 2022 [global] projection from 50 million courses to 120 million – of course, our work is never done. But, we have never and will never sacrifice product quality or patient safety to ensure expediency. We are confident in our supply capacity for Paxlovid.”
According to federal data, Pfizer appears to be roughly on track to meet its goals. The government has been able to distribute 265,000 Paxlovid courses so far.” (E)
“Paxlovid scored a recent boost from the feds, which bought 20 million courses of the treatment in April and pledged to work with Pfizer to increase production and supply of the antiviral.
Two years into the pandemic, COVID-19’s potential to fuel domestic drug manufacturing hasn’t faded.
Take Pfizer’s new $120 million investment, for example. The company on Monday said it’s plugging the cash into its Kalamazoo, Michigan, plant—the Big Pharma’s largest manufacturing facility—to bolster production of its oral COVID-19 antiviral Paxlovid, also known as nirmatrelvir and ritonavir tablets.
The move is set to create more than 250 jobs at the Kalamazoo campus, which marks “another major step” in Pfizer’s bid to “bring more key biopharmaceutical manufacturing to the U.S.,” the company said in a release.” (F)
“The U.S. threw out 82.1 million COVID-19 vaccine doses between December 2020 and mid-May 2022, tossing about 11% of the doses distributed.
Pharmacies, states, territories, and federal agencies got rid of doses that expired on shelves before they could be used, that spoiled when the power went out or freezers broke, and that were tossed at the end of the day when no one used the remaining doses in an opened vial, according to NBC News.
The overall number of discarded doses falls in line with public health estimates for large vaccination campaigns using multidose vials, according to the World Health Organization’s vaccine wastage rates calculator. But public health experts have said the waste is still alarming when 53% of fully vaccinated Americans haven’t gotten a booster shot.
“It’s a tremendous loss to pandemic control, especially in the context of millions of people around the world who haven’t even been able to get a first dose,” Sheela Shenoi, MD, medical director of the infectious diseases program at the Yale School of Medicine, told NBC News.
Two retail pharmacy chains – CVS and Walmart – were responsible for more than 25% of the doses that were thrown away, partly due to the high number of doses they handled, the news outlet reported. CVS wasted nearly 11.8 million doses, or about 13% of the nearly 90 million doses it received. Walmart wasted about 10 million doses, or about 22% of the 44 million doses it received.
Five other major pharmacies and dialysis centers – Costco, DaVita, Health Mart, Publix, and Rite Aid – threw away fewer overall doses but a higher share. They wasted more than a quarter of the doses they received, which was much higher than the national average. DaVita, which runs dialysis centers across the U.S., threw out more than 39% of its doses.
What’s more, two states threw away more than a quarter of their doses. Oklahoma tossed 28% of the 4 million doses it received, and Alaska threw away nearly 27% of the 1 million doses it received.
Public health officials have noted that the coronavirus vaccine, unlike other shots, is packaged in multidose vials. That means the doses must be used within hours once a vial is opened; otherwise, the vial must be thrown away…
The CDC is working with manufacturers to create smaller, single-dose vials to reduce waste.
“Vaccine utilization was very high in the early months of the vaccination campaign and has decreased in recent months,” Kate Grusich, a CDC spokesperson, told NBC News.
“However, our commitment to providing vaccine, and now boosters, to anyone who wants one remains unchanged,” she said.” (G)
““It feels cautiously good right now,” said Dr. Dan Kaul, an infectious diseases specialist at the University of Michigan Medical Center in Ann Arbor. “For the first time that I can remember, pretty much since it started, we don’t have any (COVID-19) patients in the ICU.”..
Today, in the third year of the pandemic, it’s easy to feel confused by the mixed picture: Repeat infections are increasingly likely, and a sizeable share of those infected will face the lingering symptoms of long COVID-19.
Yet, the stark danger of death has diminished for many people.
“And that’s because we’re now at a point that everyone’s immune system has seen either the virus or the vaccine two or three times by now,” said Dr. David Dowdy, an infectious disease epidemiologist at Johns Hopkins Bloomberg School of Public Health. “Over time, the body learns not to overreact when it sees this virus.”..
The death rate for COVID-19 has been a moving target, but recently has fallen to within the range of an average flu season, according to data analyzed by Arizona State University health industry researcher Mara Aspinall…
Experts agree a new variant might arise capable of escaping the population’s built-up immunity. And the fast-spreading omicron subtypes BA.4 and BA.5 might also contribute to a change in the death numbers.
“We thought we understood it until these new subvariants emerged,” said Dr. Peter Hotez, an infectious disease specialist at the Baylor College of Medicine in Texas.
It would be wise, he said, to assume that a new variant will come along and hit the nation later this summer.
“And then another late fall-winter wave,” Hotez said.
In the next weeks, deaths could edge up in many states, but the U.S. as a whole is likely to see deaths decline slightly, said Nicholas Reich, who aggregates coronavirus projections for the COVID-19 Forecast Hub in collaboration with the Centers for Disease Control and Prevention.
“We’ve seen COVID hospitalizations increase to around 5,000 new admissions each day from just over 1,000 in early April. But deaths due to COVID have only increased slightly over the same time period,” said Reich, a professor of biostatistics at University of Massachusetts Amherst.
Unvaccinated people have a six times higher risk of dying from COVID-19 compared with people with at least a primary series of shots, the CDC estimated based on available data from April.
This summer, consider your own vulnerability and that of those around you, especially in large gatherings since the virus is spreading so rapidly, Dowdy said.
“There are still people who are very much at risk,” he said.” (H)
“At a glance, the pandemic picture in the United States may seem remarkably stable. The average number of new confirmed coronavirus cases per day has hardly budged for weeks, hovering between 95,000 and 115,000 a day each day in June.
A closer look shows that as public testing sites run by state and local governments have winnowed, more states have also stopped giving daily data updates, creating a foggier look at the state of virus across the country.
That comes as new federal estimates on Tuesday showed that the rapidly spreading Omicron subvariant known as BA.5 has become dominant among new coronavirus cases. As of the week ending Saturday, BA.5 made up about 54 percent of new cases in the United States, according to the Centers for Disease Control and Prevention. Just a week ago, the agency’s estimates had put BA.5 and BA.4, another Omicron subvariant, together as dominant, a trend experts had predicted. The new statistics, released Tuesday morning, are based on modeling and can be revised as more data comes in.
BA.4 and BA.5 are able to evade some of the antibodies produced after coronavirus vaccinations and infections, including infections caused by some other versions of Omicron. But researchers in South Africa recently reported that a spring surge driven by BA.4 and BA.5 did not appear to cause significantly more severe disease than the nation’s first Omicron wave.
The reduction in U.S. public testing means that lab-based P.C.R. testing capacity in July will be only half of what it was in March, according to a recent estimate by Health Catalysts Group, a research and consulting firm. Even a few testing companies announced layoffs and closures last week.” (I)
“New York City became the first to launch a “Test to Treat” program that provides COVID-19 antiviral treatments, including Paxlovid, for people who test positive for the novel coronavirus, according to city health officials and White House response coordinator Dr. Ashish Jha.
The treatments, which are provided free of cost, are available at three sites. The program will expand to a total of 30 sites by the end of July. The select testing sites are managed by the New York City Test & Trace Corps.
Clinicians will provide the treatment at the sites, which are currently located outside of local pharmacies to allow for the distribution of the medication.
The program launch comes as the city’s COVID test positivity rate is above 10% for the first time since January. The number of positive cases has also risen 10% from just two weeks ago, according to data from the city’s Department of Health and Mental Hygiene.
New York City Mayor Eric Adams speaks at a press conference about New York City’s new mobile COVID-19 “Test To Treat” program, June 30, 2022, in New York.
Experts previously suggested the true test positivity rate could even be higher due to the number of people testing positive with at-home rapid tests.
This is a trend seen on the national level as well. According to data from the Centers of Disease Control and Prevention, as of June 26, the seven-day average for the COVID test positivity rate in the United States was 15.65%, the highest figure recorded since Feb. 3.
The average number of daily COVID-19 related deaths has risen to over 300. The U.S. was reporting just over 2,700 deaths every day at one point in February.
“COVID is a formidable opponent,” New York City Mayor Eric Adams said at a press conference Thursday. “It pivots and shifts and we are clear that we are going to pivot and shift with it and we are leading the way in the country on how we utilize all of our assets to address this serious crisis that we have faced and that we cycle out of.”
The city has already been offering home delivery for city residents who receive a prescription for antiviral medication.
“We were the epicenter of the COVID pandemic at the start, but we’re leading the way [with] prevention and mitigation,” Adams said. “We are now leading the way again by having this mobile unit. This new public health service will help all New York to get access to life saving treatments.”..
“This is about equity, this is about making sure that everybody who … can benefit from treatments gets it,” Jha told reporters. “This is about meeting people where they are. Literally going into neighborhoods, going into communities and making sure that we’re not asking people to come to us. That we are going to them and that is the ultimate public health.”” (J)
“New York City suddenly removed its color-coded coronavirus alert system on Thursday just as newer Omicron subvariants are fueling another rise in cases and hospitalizations.
Mayor Eric Adams and health officials quietly took down the city’s high profile alert system that warned New Yorkers when they were at a greater risk of catching the virus and should consider taking more precautions.
Now the city’s website reads: “We are re-evaluating the city’s Covid Alert system. Check back here for updates in the coming weeks.”..
The city’s health commissioner, Dr. Ashwin Vasan, defended his decision to remove the alert system on Thursday and said that the city was “re-evaluating” its approach, though he did not offer details about what the city might do instead.
“While we continue to see a lot of transmission here in New York, we’re also at a different phase of the pandemic that demands new analytical tools to match our assessments and communications about risk with reality,” Dr. Vasan said at a news conference in Manhattan to announce new mobile testing units that will provide antiviral treatments.
Fabien Levy, a spokesman for the mayor, said in a statement on Friday that the city always intended to periodically re-evaluate the alert system as conditions changed and that Dr. Vasan proactively mentioned the change at the news conference.
“What we have seen recently is bouncing between alert levels, which doesn’t provide clear or useful information to New Yorkers,” Mr. Levy said. “All of the Covid-19 indicators continue to be updated on the Health Department’s website and we will continue to communicate our recommendations clearly.”..
New York City’s “Alert Levels” website said on Friday that the city was facing high transmission levels and that residents should continue to wear masks in public indoor settings and around crowds outdoors and test before and after travel or gatherings.
Private companies and schools have relied on the city’s alert system to make decisions over requiring masks in offices and classrooms. Without guidance from the city about the growing risk level, organizations will have to monitor the data to make decisions on their own.
Under the color-coded alert system introduced by Mr. Adams in March, certain health policy measures were recommended at each level of risk. At the high risk level, the mayor was encouraged to require face masks in all public indoor settings and to bring back a vaccine mandate for restaurants and bars that was in place under the last mayor, Bill de Blasio.
When the city reached the high risk level in May, Mr. Adams chose not to reintroduce mask and vaccine mandates. Mr. Adams, a Democrat who took office in January, has focused on reopening the city and convincing workers to return to Manhattan, and he has argued that only a significant rise in hospitalizations would prompt more aggressive action.
Starting on Friday, Broadway theaters will be allowed to drop their mask mandates, and Mr. Adams recently removed a mask mandate for toddlers.
Dr. Jay Varma, an epidemiologist and former senior health adviser to Mr. de Blasio, said on Friday that he believed that a BA.5-driven wave was starting in the city and that health officials should provide more clear guidance to New Yorkers about how to change their behavior during regular news briefings.
“I worry that removing the alert system is a sign that the city prefers to wait until there is a marked increase in severe illness and death before any further actions will be considered,” Dr. Varma said…
The color-coded systems are based on parameters set by the C.D.C. that incorporate data on both new cases and hospitalizations. In Los Angeles, officials have indicated that indoor masking will be required should the county enter the “high” level.” (K)
“The government has greenlit new vaccines to defend against the latest Omicron variants. But the shots won’t arrive until the fall, and cases are rising now…
The Biden administration is betting that the new cocktails, the centerpiece of an effort to drastically speed up vaccine development, might appeal to the half of inoculated Americans who have so far spurned booster shots, a key constituency in the fight against future Covid waves.
Vaccine updates are becoming more urgent by the day, many scientists said. The most evasive forms of Omicron yet, known as BA.4 and BA.5, appear to be driving a fresh surge of cases across much of the United States. The same subvariants have sent hospital admissions climbing in Britain, France, Portugal, Belgium and Israel.
Covid deaths in the United States, which had been hovering for months near their lowest levels of the pandemic, are rising again. In the worst case, epidemiologists have predicted some 200,000 Covid deaths in the United States within the next year.
“We’re hoping that we can convince people to go get that booster,” said Dr. Peter Marks, who oversees the vaccines office at the Food and Drug Administration, “and help mature their immune response and help prevent another wave.”
Many scientists believe that updated boosters will be critical for diversifying people’s immune defenses as subvariants eat away at the protection offered by vaccines. Catching up with a virus that has been so rapidly mutating may be impossible, they said. But it was far better to be only a few months, rather than a couple of years, behind the pathogen.
“Omicron is so different that, to me, it seems pretty clear we’re starting to run out of ground in terms of how well these vaccines protect against symptomatic infections,” said Deepta Bhattacharya, an immunologist at the University of Arizona. “It’s very important that we update the shots.”
Now, the question is whether those modified boosters will arrive in time. In a bid to match the latest forms of the virus, the F.D.A. asked vaccine manufacturers to tailor their new shots to the BA.4 and BA.5 subvariants, rather than to the original version of Omicron from last winter.
Virologists said that a subvariant vaccine would generate not only the strongest immune defenses against current versions of the virus, but also the type of broad antibody response that will help protect against whatever form of the virus emerges in the months ahead.
But building a fall booster campaign around vaccines at the forefront of the virus’s evolution could also come at a cost. Pfizer and Moderna said that they could deliver subvariant vaccine doses no earlier than October. Some F.D.A. advisers warned in a public meeting last week that the timeline could be slowed even further by any number of routine delays.
In contrast, a vaccine targeting the original version of Omicron is closer at hand: Moderna and Pfizer have already started making doses tailored to the original form of Omicron, and Moderna said that it could start supplying them this summer. Whether the benefits of a newer subvariant vaccine outweigh the drawbacks of having to wait longer depends on when exactly it arrives and how much havoc the virus wreaks before then, scientists said.
They said that having some form of an updated vaccine by the fall was crucial.
“I would lean toward thinking BA.4, BA.5 is a good choice unless it dramatically extends the timeline,” said Jesse Bloom, a virologist at the Fred Hutchinson Cancer Center in Seattle, voicing support for the subvariant vaccine. “If using BA.4, BA.5 only modestly extends the timeline, I think it’s a good choice.”
The updated shots will test the public’s openness to an accelerated vaccine program that is reminiscent of the way annual flu shots are formulated, but that is entirely new when it comes to the coronavirus.
The original Covid vaccines had to withstand slow and laborious testing: Volunteers took the shots and then went about their lives while researchers tracked who got sick. But there is now ample evidence that the shots are safe. And any tweaks to the recipe could be wasted if scientists were to spend the better part of a year testing them.
Instead, vaccine manufacturers have been studying volunteers’ blood samples in the lab to gauge their immune responses to a booster that is tailored to the first version of Omicron. The subvariant boosters have so far been through lighter testing: Pfizer has studied only how they have affected antibody responses in mice.
The F.D.A. said that it would not require clinical trial data for the subvariant boosters before authorization and would rely instead on studies of boosters targeting the original version of Omicron. Some scientists said that authorizing modified vaccines without time-consuming human studies was essential to keeping up…
Scientists said they were eager for a clearer picture of how updated vaccine candidates would be chosen in the future and how quickly they could be made. Some also pressed for closer cooperation between American regulators and the World Health Organization, which supports updating the vaccines but with the original version of Omicron, not its latest subvariants, as a different way of broadening immune responses.
The ultimate goal, many scientists said, was to compress the time between when the next immune-dodging variant emerges and when people can be vaccinated against it.
“We’re now seven months out from when we first detected Omicron,” said Dr. Michael Z. Lin, a professor of neurobiology at Stanford who has tracked the regulatory process. “We need a rapid way for strain selection, and it needs to be more rapid than what we’ve done so far.” (L)
“There is no right answer but variant chasing is a flawed approach. By the time a BA.5 vaccine booster is potentially available, who knows what will be the predominant strain? All of this gets back to the vital need for new generation of vaccines that are universal, that is variant-proof—either against all sarbecoviruses or against all β-coronaviruses. And the pivotal importance of nasal vaccines to promote mucosal immunity and help block the transmission chain. These goals are paramount, along with more and better antiviral drugs, but they are not getting adequate traction or priority.
My recent posts about our Covid capitulation and the risk of reinfection have tried to hammer home the imperative of next-generation vaccines (pan-coronaviruses, as described above, and nasal) but the frustration keeps mounting as we now confront unsatisfactory deliberations on variant chasing. Meanwhile, new versions of the virus (think: the time it took from Omicron BA.1 to get to BA.5) are accelerating and we’re not done yet, by any stretch. It’s frankly sickening to watch this virus continue to outrun us, knowing we are so damn capable of getting ahead of it.” (M)
ADDENDUM -July 10th
“Physicians usually understand the value pharmacists bring to the care team, given the latter profession’s proven expertise in managing medications. But the American Medical Association (AMA) apparently didn’t get the memo, judging by the contention that has broken out between the two groups over President Joe Biden’s “test-to-treat” initiative governing COVID-19 therapeutics.
Pharmacists are praising the initiative, which allows people to get tested for COVID-19 at pharmacy-based clinics and receive oral treatments immediately if they test positive, as a critical component of the national effort to protect Americans from the coronavirus. But in a March 4 statement, the AMA blasted the plan. “Establishing pharmacy-based clinics as one-stop shopping for COVID-19 testing and treatments is extremely risky,” the group noted. The clinics “typically treat simple illnesses such as strep throat. Yet, COVID-19 is a complex disease and there are many issues to consider when prescribing COVID-19 antiviral medications. Leaving prescribing decisions this complex in the hands of people without knowledge of a patient’s medical history is dangerous in practice and precedent.”
Michael Ganio, PharmD, the senior director for pharmacy practice and quality at ASHP, disagreed with that characterization. “Pharmacists are the most qualified healthcare professionals to review DDIs [drug-drug interactions], make dose adjustments and navigate a patient’s medical history,” Dr. Ganio said. “That is literally what we do all day, collaborating regularly with an interdisciplinary team. In fact, our members are frequently being consulted by physicians who are not comfortable with managing all the DDIs associated with these antivirals, and that predates the test-to-treat program.” (N)
- A.Fauci says he’s taking 2nd course of Paxlovid after experiencing rebound with the antiviral treatment, by Arielle Mitropoulos, https://abcnews.go.com/US/fauci-taking-2nd-paxlovid-experiencing-rebound-antiviral-treatment/story?id=85922417
- B.What is COVID-19 ‘rebound’? CDC explains phenomenon affecting Fauci, some Paxlovid users, BY MICHAEL BARTIROMO, https://thehill.com/homenews/nexstar_media_wire/3541510-what-is-covid-19-rebound-cdc-explains-phenomenon-affecting-fauci-some-paxlovid-users/
- C.Fauci says he believes Paxlovid kept him out of the hospital, even though he tested positive again., By Sheryl Gay Stolberg, https://www.nytimes.com/2022/06/29/us/politics/fauci-paxlovid-covid.html?referringSource=articleShare
- D.U.S. pharmacists receive permission from the F.D.A. to prescribe Pfizer’s Covid pills., By Rebecca Robbins, https://www.nytimes.com/live/2022/07/06/world/covid-19-mandates-vaccine-cases?referringSource=articleShare#fda-paxlovid-prescriptions-pharmacies
- E.Feds’ contract with Pfizer for Paxlovid has some surprises, by SYDNEY LUPKIN, https://www.npr.org/sections/health-shots/2022/02/01/1075876794/feds-contract-with-pfizer-for-paxlovid-has-some-surprises
- F.Pfizer makes $120M domestic manufacturing play to shore up COVID antiviral supply, By Fraiser Kansteiner, https://www.fiercepharma.com/manufacturing/pfizer-makes-120m-domestic-manufacturing-play-shore-covid-antiviral-supply
- G.More Than 82 Million COVID Vaccine Doses Wasted in U.S.: Report, By Carolyn Crist, https://www.webmd.com/vaccines/covid-19-vaccine/news/20220607/millions-covid-vaccine-doses-wasted-us-report
- H.For now, wary US treads water with transformed COVID-19, By CARLA K. JOHNSON, https://apnews.com/article/covid-science-health-infectious-diseases-fb25f987bab09a11be31a32e832dd9de
- I.As BA.5 becomes dominant among new U.S. cases, reduced state reporting is blurring the real-time look at the virus., https://www.nytimes.com/live/2022/07/05/world/covid-19-mandates-vaccine-cases?referringSource=articleShare#covid-testing-data
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