POST 265. August 4, 2022. Monkeypox. “The shortage of vaccines to combat a fast-growing monkeypox outbreak was caused in part because the Department of Health and Human Services failed early on to ask that bulk stocks of the vaccine it already owned be bottled for distribution…”

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When the monkeypox outbreak was first detected in the United States, it seemed, as far as infectious-disease epidemics go, like one this country should be able to handle. Tests and antivirals for the virus already existed; the government had stockpiled vaccines. Unlike SARS-CoV-2, monkeypox was a known entity, a relative softball on the pathogenic field. It wasn’t hypertransmissible, moving mainly through intimate contact during the disease’s symptomatic phase; previous epidemics had, with few interventions, rather quickly burned themselves out. The playbook was clear: Marshal U.S. resources and ensure they go to those most at risk, send aid abroad, and knock it out of the park. “If there was one virus that would lend itself to containment,” says Boghuma Kabisen Titanji, a virologist and infectious-disease physician at Emory University, this should have been it…

Through much of May and June, monkeypox tests remained siloed within the CDC and its network of public-health labs, already stretched by the pandemic response. Health-care providers had to shuttle specimens to these centers for diagnosis, leaving patients on tenterhooks for days, even weeks, and delaying treatment, vaccination, and contact tracing. Even now, after testing capacity has climbed with the help of commercial labs, typical result turnaround times are stretching long. In Missouri, for instance, “they’re still telling us three to four days” at best, Hilary Reno, the medical director of the St. Louis County Sexual Health Clinic, told me…

Experts have praised some of the CDC’s efforts to avoid stigmatizing at-risk groups, which, at this juncture, remains essential… At the same time, some people have been so fearful of casting monkeypox as an exclusively “gay disease” that sex has almost been censored from discussions, “giving people a misperception of the different risks that populations are facing right now,” Thrasher said. Especially while supplies remain so limited, we need to be “vaccinating people where the virus is moving.” Which means “we need to give both messages simultaneously,” Park said, “that this is not something that only affects gay men” while nodding to the fact that monkeypox is still “primarily affecting certain communities,” a trend that should influence the distribution of shots…”

The top priority now, experts told me, should be funneling funds toward distributing vaccines and scaling up testing. Health workers and patients need continued guidance on the disease’s often-subtle symptoms and the possibility of silent transmission, as well as the resources to administer speedy care. Paid sick leave and housing support would also help ease the burden of monkeypox isolation, which, given the lengthy course of symptoms, can last for weeks. Should such efforts fall short, as they clearly have with SARS-CoV-2, monkeypox could become the second virus to set up permanent residence in the U.S. in the span of three years—giving it all the more opportunity to find new ways to spread, shape-shift, and propagate disease. Preventing that means acting decisively now, to make up for the time we’ve already lost.” (A)

“Less than a decade ago, the United States had some 20 million doses of a new smallpox vaccine — also effective against monkeypox — sitting in freezers in a national stockpile.

Such vast quantities of the vaccine, known today as Jynneos, could have slowed the spread of monkeypox after it first emerged in the United States in mid-May. Instead, the supply, known as the Strategic National Stockpile, had only some 2,400 usable doses left at that point, enough to fully vaccinate just 1,200 people.

The rest of the doses had expired.

Now, some 10 weeks into the outbreak, many people at high risk who want to get vaccinated have been unable to find a dose and may not be able to find one for months.

The chain of events that led the stockpile of a now-critical vaccine to dwindle to near nothing in the United States is only now emerging…

At several points federal officials chose not to quickly replenish doses as they expired, instead pouring money into developing a freeze-dried version of the vaccine that would have substantially increased its three-year shelf life.

As the wait for a freeze-dried vaccine to be approved by the Food and Drug Administration dragged on over the last decade, the United States purchased vast quantities of raw vaccine product, which has yet to be filled into vials.

The raw, unfinished vaccine remains stored in large plastic bags outside Copenhagen, at the headquarters of the small Danish biotech company Bavarian Nordic, which developed Jynneos and remains its sole producer.

For nearly 20 years, the United States government has helped fund the company’s development of the vaccine, clinical trials and manufacturing process, at a cost that passed the $1 billion mark by 2014 and is hurtling toward $2 billion. Despite this, the United States now finds itself unable to procure enough doses to quickly launch a widespread vaccination campaign for those at highest risk: men who have sex with men, and in particular, those who have multiple partners.

One reason for the reduction in the U.S. stockpile of Jynneos is that the federal officials overseeing it had not viewed monkeypox as much of a problem, or at least as their problem. They were focused on the most dangerous and deadly scenarios, such as a bioterror attack involving smallpox or anthrax.” (B)

“There is growing concern that the United States may have lost its chance to contain the monkeypox virus, as the nation has been slow to vaccinate those most at risk on a broader scale.

“I think we’re going to have to live with it until they vaccinate every high-risk person,” Dr. Robert Murphy, executive director of the Havey Institute for Global Health at the Northwestern University Feinberg School of Medicine, said this week.

Vaccinating against monkeypox has been a part of the Biden administration’s response to the global outbreak since the nation identified its first case of the disease in May, but supplies have been limited, even as demand for protection from the virus surges.

At first, officials at the US Centers for Disease Control and Prevention announced that vaccines for monkeypox were being released from the Strategic National Stockpile and offered to the “high-risk” contacts of monkeypox patients, as well as the health-care workers treating them.

Vaccinating someone already exposed to monkeypox to help prevent illness is called post-exposure prophylaxis or a ring vaccination strategy. Vaccinating a patient’s close circle of contacts is like vaccinating a “ring” around them.

This approach has been used in response to sexually transmitted infections and prior monkeypox outbreaks.

“We can have a really effective strategy of containment and elimination by identifying all the cases and then providing the cases with treatment and the close contacts of those cases with post-exposure prophylaxis,” said a federal health adviser who requested anonymity because they’re not a government employee and don’t speak for any federal agency.

Testing is crucial to getting monkeypox under control, but there’s a ‘shocking’ lack of demand

“We know that this works,” the adviser said. “We have data from other outbreaks to say that it is effective. And so in the beginning, when cases were low — in the tens, the dozens of cases — we were able to effectively work with jurisdictions to identify those cases and, through consultation, figure out how many doses of vaccines would they need to vaccinate as many contacts as they think existed.”

But toward late June, the monkeypox outbreak had spread.

The CDC’s initial strategy “was just doomed to failure,” Murphy said, referencing how a “ring” strategy requires swift and robust outreach to all known contacts of a monkeypox patient — which was becoming increasingly difficult to do as cases were growing, and in more places.

“A ring vaccination strategy was never going to work, frankly,” Murphy said. “I mean, look how fast this virus has spread.”..

Some local health officials saw the writing on the wall early in the outbreak and never implemented a ring vaccination of just close contacts. Instead, vaccines have been offered to a broader group of higher-risk people from the beginning…

With limited supply, cities prioritize first doses

On Monday, the DC Department of Health announced that due to the “very limited” supply of vaccines, only first doses will be provided to high-risk residents, even though Jynneos is a two-dose vaccine. Second doses will be provided at a later time.

“This decision is based on the available scientific evidence, the acceleration of the outbreak, the demand for vaccine from the high number of eligible people, and extreme shortages of the JYNNEOS Monkeypox vaccine nationally,” the announcement said. “DC Health is confident that additional vaccine doses will be available when needed for those who have received their first dose.”

In New York City, which also expanded eligibility for the monkeypox vaccine to any adult in a high-risk group, first doses have been prioritized.

“New York City is the epicenter of the monkeypox outbreak in the U.S. and yet does not have sufficient vaccine supply,” the city announced in mid-July. “Given the rapid increase in cases, the Health Department has decided that providing first doses to offer protection to more at-risk New Yorkers is the best strategy until we receive adequate vaccine supply. This single dose strategy is consistent with the monkeypox vaccine distribution strategy taken in the UK and Canada.” (C)

“When about 100 cases of ‌‌monkeypox had been confirmed or suspected in Europe‌ in May, it was clear the virus was spreading outside the areas where it was previously seen‌‌. Some on social media ‌‌suggested it might already be ‌spreading rapidly in communities in Europe and the ‌United States. These reports should have been a code red for federal infectious disease response.

But it wasn’t until late June that the C‌enters for Disease Control and Prevention expanded testing for monkeypox to large commercial labs like Quest Diagnostics and Labcorp for more capacity and access. The C.D.C. had gone through its standard playbook, ticking through its protracted checklist.

Compared with the agency’s botched rollout of a test for the coronavirus, the monkeypox test came at warp speed. But the virus spread even faster. If ‌American leaders wanted to quash the outbreak, ‌‌the United States should have been testing all people who presented with what was presumed to be atypical cases of diseases like genital herpes and zoster infection; both can cause rashes that sometimes resemble monkeypox. That might have required 15,000 tests a week, by my rough estimate. From mid-May to the end of June, the U‌‌nited States tested only about 2,000 samples.

Our country’s response to monkeypox ‌‌has been plagued by the same shortcomings we had with Covid-19. Now if monkeypox ‌gains a permanent foothold in the U‌nited States and becomes an endemic virus that joins our circulating repertoire of pathogens, it will be one of the worst public health failures in modern times not only because of the pain and peril of the disease but also because it was so avoidable. Our lapses extend beyond political decision making to the agencies tasked with protecting us from these threats. We don’t have a federal infrastructure capable of dealing with these emergencies.

The failures that got us here fit a now familiar pattern.

Early on, similar to the early days of Covid, testing access for monkeypox was limited, despite ample evidence that monkeypox was spreading in the United States. The Strategic National Stockpile was meant as a hedge against viral contingencies, but when the coronavirus struck, it lacked adequate supplies of testing equipment, ventilators and masks. With monkeypox, the government hadn’t stockpiled enough of the only vaccine, Jynneos, that was indicated for prevention of the disease and considered safe for use. The United States had on hand fewer than 2,400 doses in mid-May, mostly as a hedge against the risk of smallpox, which was the vaccine’s other indication.

There are more parallels between our failings ‌‌to combat Covid and monkeypox. Each time, the reflex has been to blame political leadership for poor planning, lack of urgency‌‌ and clumsy execution. It’s true that ‌‌both responses have been plagued by an absence of coordination among federal agencies like the Food and Drug Administration, which I led under the first two years of the Trump administration; the C.D.C.; and the components of the Health and Human Services Department that are responsible for different aspects of response. But systemic failings also rest with the bureaucracy charged with countering these threats.

The C.D.C. should lead America’s response to viral exigencies. But the agency isn’t a crisis organization. It lacks the infrastructure to mobilize a rapid response and is too hidebound and process driven to move quickly. Its cultural instinct is to take a deliberative approach, debating each decision. With Covid, the virus ‌‌gained ground quickly. With ‌‌monkeypox, which spreads more slowly, typically through very close contact, the shortcomings of C.D.C.’s cultural approach haven’t been as acute yet. But the shortfalls are the same….

The Biden administration needs to get the C.D.C. back to its disease control roots, by transferring some of its disease prevention work to other agencies. The F.D.A. can handle smoking cessation, leveraging its regulatory toolbox. The National Institutes of Health can tackle cancer and heart disease. Focus the C.D.C. more on its core mission of outbreak response. And imbue the agency with the national security mind-set that it had at its origins. If the C.D.C.’s mission were more tightly focused on the elements required for handling contagion, Congress might be more willing to invest it with the robust authority to do that targeted mission well. Congress would need to reprogram budget lines to get it done, but someone needs to start that conversation.

Time is running out. Diseases like Zika, Covid‌ and ‌‌monkeypox are a dire warning that dangerous pathogens are on the march. The next one could be worse — a deadly strain of flu or something more sinister like Marburg virus. We’ve now had ample notice that the nation continues to be unprepared and that our vulnerabilities are enormous.” (D)

“Critics fear a repeat of the catastrophic inequity problems seen during the coronavirus pandemic.

“The mistakes we saw during the COVID-19 pandemic are already being repeated,” said Dr. Boghuma Kabisen Titanji, an assistant professor of medicine at Emory University.

While rich countries have ordered millions of vaccines to stop monkeypox within their borders, none have announced plans to share doses with Africa, where a more lethal form of monkeypox is spreading than in the West.

To date, there have been more than 22,000 monkeypox cases reported in nearly 80 countries since May, with about 75 suspected deaths in Africa, mostly in Nigeria and Congo. On Friday, Brazil and Spain reported deaths linked to monkeypox, the first reported outside Africa. Spain reported a second monkeypox death Saturday.

“The African countries dealing with monkeypox outbreaks for decades have been relegated to a footnote in conversations about the global response,” Titanji said…

On Thursday, the Africa Centers for Disease Control and Prevention called for the continent to be prioritized for vaccines, saying it was again being left behind.

“If we’re not safe, the rest of the world is not safe,” said Africa CDC’s acting director, Ahmed Ogwell…

WHO is developing a vaccine-sharing mechanism for affected countries, but has released few details about how it might work. The U.N. health agency has made no guarantees about prioritizing poor countries in Africa, saying only that vaccines would be dispensed based on epidemiological need.

Some experts worry the mechanism could duplicate the problems seen with COVAX, created by WHO and partners in 2020 to try to ensure poorer countries would get COVID-19 shots. That missed repeated targets to share vaccines with poorer nations.

“Just asking countries to share is not going to be enough,” said Sharmila Shetty, a vaccines adviser for Medecins Sans Frontieres. “The longer monkeypox circulates, the greater chances it could get into new animal reservoirs or spread to” the human general population, she said.

At the moment, there’s only one producer of the most advanced monkeypox vaccine: the Danish company Bavarian Nordic. Its production capacity this year is about 30 million doses, with about 16 million vaccines available now.

In May, Bavarian Nordic asked the U.S. to release more than 215,000 doses it was due to receive “to assist with international requests the company was receiving,” and the U.S. complied, according to Bill Hall, a spokesman for the department of Health and Human Services. The U.S. will still receive the doses but at a later date.

Hall said the U.S. has not made any other promises to share vaccines. The U.S. has ordered by far the most number of doses, with 13 million reserved, although only about 1.4 million have been delivered.//

Dr. Ingrid Katz, a global health expert at Harvard University, said the monkeypox epidemics were “potentially manageable” if the limited vaccines were distributed appropriately. She believed it was still possible to prevent monkeypox from turning into a pandemic but “we need to be thoughtful in our prevention strategies and rapid in our response.”  (E)

“Scientists are racing to answer three questions in particular that will determine how quickly monkeypox can be stopped — if it can be stopped at all.

Exactly how is the virus spreading?

At the beginning of the outbreak, health officials asserted that the virus spread through respiratory droplets emitted when an infected person coughed or sneezed, and through close contact with pus-filled skin lesions or bedding and other contaminated materials.

All of that was true. But it may not be the whole picture.

More than 99 percent of the people infected so far are men who acquired the virus through intimate contact with other men, according to the Centers for Disease Control and Prevention. Only 13 women and two young children had been diagnosed with monkeypox as of July 25.

Researchers have found the virus in saliva, urine, feces and semen. It is unclear whether those fluids can be infectious and, in particular, whether the virus can be transmitted during sex by means other than close skin-to-skin contact. But the pattern of spread so far, along sexual networks, has left researchers wondering.

It is clear, however, that monkeypox does not spread easily and has not yet spilled into the rest of the population. The average person is not at risk from store-bought clothes, for example, or from a fleeting interaction with an infected person, as some social media posts have suggested.

According to the C.D.C., people without symptoms cannot spread monkeypox. But at least one study has detected the virus in men who did not experience any symptoms. The pattern of symptoms has also diverged from that observed in previous outbreaks…

Is one dose of the vaccine sufficient?

Jynneos, the safer of two vaccines for monkeypox, is made by Bavarian Nordic, a small company in Denmark. Supplies have been severely constrained, and the Biden administration moved slowly to acquire additional doses as the virus spread.

Now, federal officials have ordered nearly seven million doses, which will arrive in batches over the next months. So far, the administration has shipped about 320,000 doses to states. The Food and Drug Administration said on Wednesday that it had approved another 800,000 doses, but it was unclear when they would be distributed.

Jynneos is supposed to be administered in two doses 28 days apart. But some cities, including Washington and New York City, are holding back second doses until more become available, emulating a strategy adopted by Britain and Canada.

Federal health officials have advised against deferring second doses. But in studies, a single shot of Jynneos appears to be protective for up to two years. If that finding holds true in the real world, then postponing additional shots may help officials contain the outbreak by immunizing more Americans.

How well does drug treatment work?

In 2018, the F.D.A. approved a drug to treat smallpox called tecovirimat, or TPOXX, based on data from animal studies. There are only limited data on its use in people.

Supply is not an issue: The national stockpile holds about 1.7 million doses. Yet the drug has been difficult to acquire, and that has meant that ambiguities about how well and for whom the drug works have persisted even as case counts rise.

Because tecovirimat is not approved specifically to treat monkeypox, it can only be prescribed through a cumbersome “investigational drug protocol” that, until recently, required doctors to send the C.D.C. detailed reports, a journal maintained by the patients to record their progress and photographs of the lesions.

With so many hurdles, many clinics did not offer tecovirimat at all; even physicians at well-funded institutions were managing to treat only two or three patients per day…

Wider use should mean that scientists and health officials will gain a better understanding of the drug’s efficacy. The new requirements will help the C.D.C. “determine if and how well this drug works for monkeypox patients,” noted Kristen Nordlund, a spokeswoman for the agency.

The National Institute of Allergy and Infectious Diseases is planning a clinical trial of tecovirimat in adults with monkeypox infection, including people living with H.I.V., which may begin this fall. The agency is collaborating with Siga Technologies, which manufactures the drug, on another trial in the Democratic Republic of Congo, where the virus is a longtime scourge, also expected to begin this fall.” (F)

“Officials in New York City declared a public health emergency due to the spread of the monkeypox virus Saturday, calling the city “the epicenter” of the outbreak.

The announcement Saturday by Mayor Eric Adams and health Commissioner Ashwin Vasan said as many as 150,000 city residents could be at risk of infection. The declaration will allow officials to issue emergency orders under the city health code and amend code provisions to implement measures to help slow the spread.

In the last two days, New York Gov. Kathy Hochul declared a state disaster emergency declaration and the state health department called monkeypox an “imminent threat to public health.”

New York had recorded 1,345 cases as of Friday, according to data compiled by the Centers for Disease Control and Prevention. California had the second-most, with 799.

“We will continue to work with our federal partners to secure more doses as soon as they become available,” Adams and Vasan said in the statement. “This outbreak must be met with urgency, action, and resources, both nationally and globally, and this declaration of a public health emergency reflects the seriousness of the moment.”  (G)

“Illinois Gov. JB Pritzker on Monday declared the monkeypox virus a public health emergency, and declared Illinois a disaster area regarding the disease.

The declaration applies statewide, and will allow the Illinois Department of Public Health to coordinate logistics so as to aid in the distribution vaccines, and in treatment and prevention efforts. The declaration will also help coordinate the state response with the federal government.

“MPV is a rare, but potentially serious disease that requires the full mobilization of all available public health resources to prevent the spread,” Gov. Pritzker said in a news release. “That’s why I am declaring a state of emergency to ensure smooth coordination between state agencies and all levels of government, thereby increasing our ability to prevent and treat the disease quickly. We have seen this virus disproportionately impact the LGBTQ+ community in its initial spread. Here in Illinois we will ensure our LGBTQ+ community has the resources they need to stay safe while ensuring members are not stigmatized as they access critical health care.”

The proclamation takes effect immediately and will remain in place for 30 days. The World Health Organization declared monkeypox a Public Health Emergency of International Concern on July 23.

Mayor Lori Lightfoot and Chicago Department of Public Health Commissioner Dr. Allison Arwady released a statement endorsing the state Public Health Emergency declaration, and saying an additional declaration for the city is not necessary:

“This emergency declaration brings a necessary, increased focus to the Monkeypox (MPV) outbreak we’re seeing here in Chicago, across our state, and around the country. Since the beginning of this outbreak, the Chicago Department of Public Health has been working diligently with clinical and community partners to raise awareness and vaccinate residents at increased risk and will continue to do so. Ultimately, however, we need more support from the federal level to fully address the threat MPV presents to our city. It is our hope that this declaration joins a chorus of others across the nation and encourages the rapid increase and distribution of vaccines. This declaration will allow the state to use emergency procurement powers and to directly involve other state agencies, like Illinois Emergency Management Agency (IEMA), in the response statewide. Chicago does not need a separate emergency declaration as we are covered by the state one, and in addition, we already have a local emergency procurement process; a strong local distribution network; and a diverse group of clinical and community partners working to raise awareness and vaccinate Chicagoans at increased risk.

Since July 23, the number of monkeypox cases in the city of Chicago alone almost tripled in less than one week. Cases are also skyrocketing statewide.

As of Monday, a total of 520 cases of monkeypox have been reported in Illinois, according to the Illinois Department of Health. This total includes all probable and confirmed cases.”  (H)

“California on Monday evening became the latest state to declare a state of emergency due to its worsening monkeypox outbreak.

In a statement, California Gov. Gavin Newsom (D) said the proclamation is meant to help bolster the state’s efforts to combat the virus.

The state of emergency allows several measures, including the administering of Food and Drug Administration-approved monkeypox vaccines.

“California is working urgently across all levels of government to slow the spread of monkeypox, leveraging our robust testing, contact tracing and community partnerships strengthened during the pandemic to ensure that those most at risk are our focus for vaccines, treatment and outreach,” Newsom said.

He added, “We’ll continue to work with the federal government to secure more vaccines, raise awareness about reducing risk, and stand with the LGBTQ community fighting stigmatization.”

The proclamation comes as California has distributed more than 25,000 vaccine doses in addition to the separate vaccine allocation sent to Los Angeles County.

“The state allocates doses to local health departments based on a number of factors, including the number of reported monkeypox cases in an area and estimate of at-risk populations,” Newsom’s office noted.”  (I)

“President Joe Biden has appointed two top federal officials to coordinate his administration’s response to monkeypox, the White House said on Tuesday, as more states declared emergencies to help boost vaccines and other resources to combat the virus.

The top officials from the Federal Emergency Management Agency (FEMA) and the Centers for Disease Control and Prevention (CDC) will coordinate the U.S. response across the federal government even as Biden’s administration has stopped short of declaring a national emergency.

The appointments come as the United States aims to bolster vaccination efforts to slow the spread of a monkeypox outbreak that has infected more than 5,800 Americans.

“Over the coming weeks … the administration will advance and accelerate the United States’ monkeypox response to mitigate the spread of the virus, protect individuals most at risk of contracting the virus, and care for those who have been afflicted with it,” the White House said in a statement…

Robert Fenton, a FEMA regional administrator, will serve as the White House monkeypox coordinator and Demetre Daskalakis, CDC’s HIV prevention chief, will serve as deputy coordinator.

The pair will coordinate Biden’s response “including equitably increasing the availability of tests, vaccinations and treatments,” the White House said. The administration has estimated it may need nearly $7 billion to combat the outbreak, according to the Washington Post.” (J)

“The shortage of vaccines to combat a fast-growing monkeypox outbreak was caused in part because the Department of Health and Human Services failed early on to ask that bulk stocks of the vaccine it already owned be bottled for distribution, according to multiple administration officials familiar with the matter.

By the time the federal government placed its orders, the vaccine’s Denmark-based manufacturer, Bavarian Nordic, had booked other clients and was unable to do the work for months, officials said — even though the federal government had invested well over $1 billion in the vaccine’s development.

The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate are needed to fight the outbreak. It does not expect the next delivery, of half a million doses, until October. Most of the other 5.5 million doses the United States has ordered are not scheduled to be delivered until next year, according to the federal health agency.

To speed up deliveries, the government is scrambling to find another firm to take over some of the bottling, capping and labeling of frozen bulk vaccine that is being stored in large plastic bags at Bavarian Nordic’s headquarters outside Copenhagen. Because that final manufacturing phase, known as fill and finish, is highly specialized, experts estimate it will take another company at least three months to gear up. Negotiations are ongoing with Grand River Aseptic Manufacturing, a Michigan factory that has helped produce Covid-19 vaccines, to bottle 2.5 million of the doses now on order, hopefully shaving months off the timetable, according to people familiar with the situation.

Health and Human Services officials so miscalculated the need that on May 23, they allowed Bavarian Nordic to deliver about 215,000 fully finished doses that the federal government had already bought to European countries instead of holding them for the United States.

At the time, the nation had only eight confirmed monkeypox cases, agency officials said. And it could not have used those doses immediately because the Food and Drug Administration had not yet certified the plant where the vaccine, Jynneos, was poured into vials…

Lawrence O. Gostin, a former adviser to the Centers for Disease Control and Prevention who has consulted with the White House about monkeypox, said the government’s response has been hobbled by “the same kinds of bureaucratic delays and forgetfulness and dropping the ball that we did during the Covid pandemic.”

The obstacles to filling and finishing vials follow other missteps that have limited vaccine supply. The United States once had some 20 million doses in a national stockpile but failed to replenish them as they expired, letting the supply dwindle to almost nothing. It had 372,000 doses ready to go in Denmark but waited weeks after the first case was identified in mid-May before requesting the delivery of most of those doses. Another roughly 786,000 doses were held up by an F.D.A. inspection of the manufacturer’s new fill-and-finish plant but have now been shipped…

Mr. Gostin said the nation’s public health agencies have been “kind of asleep at the wheel on this,” and the new coordinators should help with “unblocking all of the obstacles to procuring and delivering vaccines and drugs, which has been deeply frustrating.”..

With too few doses, health officials apparently plan to rely heavily on the “test and trace” strategy that figured heavily in the early stages of the Covid pandemic. As the pandemic escalated, the sheer torrent of cases overwhelmed the ability of health officials to contact people who might have been infected by someone who had tested positive for the coronavirus. Once Covid vaccines became available, they became the cornerstone of the administration’s pandemic response.

Through early June, Health and Human Services officials appeared firmly convinced that the United States had more than enough supply of the monkeypox vaccine, called Jynneos, to handle what appeared to be a handful of cases.” (K)

“The White House today declared monkeypox a public health emergency.

“We are prepared to take our response to the next level in addressing this virus and we urge every American to take monkeypox seriously,” Health and Human Services Secretary Xavier Becerra said to reporters during a briefing on Thursday.

A public health emergency can trigger grant funding and open up more resources for various aspects of a federal response. It also allows the Secretary to enter into contracts for treatments and other necessary medical supplies and equipment, as well as support emergency hospital services, among other things. Public health emergencies last for 90 days but can be extended by the Secretary.

CDC Director Rochelle Walensky, said the declaration will provide resources and increase access to care. She also said it will expand the CDC’s ability to share data.

Some have been calling for a federal public health emergency saying it will signal to the country that this is a serious outbreak…

The focus of the Biden Administration’s response to the outbreak has been to vaccinate those at high risk of contracting the disease, but critics say vaccine availability has been limited and slow to come online.

The Administration says it has made more than one million doses of the JYNNEOS vaccine available to states and territories to order.” (L)

“As monkeypox continues its relentless spread around the globe, organizations in the U.S. are taking steps to safeguard the nation’s blood supply.

In addition to temperature checks that are part of standard health screens for prospective donors, the American Red Cross is now checking for the distinctive lesions that are a hallmark of the disease as part of routine arm examinations. And beginning in October, the Red Cross will require individuals who have been diagnosed with monkeypox or exposed to someone with a monkeypox infection to wait at least 21 days before giving blood.” (P)

“Health officials are considering changing the way monkeypox vaccine doses are administered because the country is “at a critical inflection point” with the virus’ spread, US Food and Drug Administration Commissioner Dr. Robert Califf told reporters on Thursday.

“In recent days, it’s become clear to all of us that given the continued spread of the virus, we’re at a critical inflection point, dictating the need for additional solutions to address the rise in infection rates,” Califf said. “The goal has always been to vaccinate as many people as possible.”

The commissioner said officials are considering allowing health care providers to be able to use a dose-sharing method where one vial of Jynneos vaccine — previously used as one dose — will be used to administer up to five separate doses.

This approach would change the way Jynneos is administered, Califf said. Instead of the vaccine being administered in the fat layer under the skin, it will be delivered underneath the skin layer.

“There are some advantages to intradermal administration including an improved immune response to the vaccine,” Califf said. “It’s important to note that overall safety and efficacy profile will not be sacrificed for this approach. Please know, we’ve been exploring all scientifically feasible options and we believe this could be a promising approach.”” (M)

“The CDC does list contact with respiratory secretions as a method of transmission, but notes “scientists are still searching” for “how often” it’s spread this way and when an infected, symptomatic person “might be more likely to spread the virus through respiratory secretions.” (Q)


“President Joe Biden removes his face mask as he arrives to speak during a meeting with CEOs in the White House complex Thursday, before he tested positive for Covid-19 again on Saturday, slightly more than three days after he was cleared to exit coronavirus isolation.” (N)

“As the wave of omicron coronavirus subvariant BA.5 continues to flood the US, daily COVID-19 hospitalizations are four times higher than four months ago, according to the latest data from the Centers for Disease Control and Prevention.

The data reflects the high ongoing transmission of coronavirus subvariants adept at evading fading immune responses in a population that is largely unboosted.

In early April, as the US fell into a brief pandemic lull in the wake of the towering BA.1 omicron wave, the seven-day rolling average for new hospitalizations sank to around 1,420 per day nationwide. Now, after waves of subvariants BA. 2, BA.2.12.1, and the current BA.5, hospitalizations have floated back up. The current seven-day rolling average is nearing 6,300. Overall, more than 37,000 people in the US are currently hospitalized with COVID-19.” (O)