Monkeypox

[reader]

From Bangkok Post

Thailand's 3rd monkeypox case found in Phuket

Thailand's third case of monkeypox has been found in Phuket, Department of Disease Control director-general Opas Karnkawinpong said on Wednesday.

Dr Opas said the latest monkeypox case is a 25-year-old German man who arrived in Phuket on July 18 as a tourist.

The man was believed to have caught the virus in another country because the incubation period  is 21 days. Officials were tracking down people who had been in close contact with him, for examination, he said.

Dr Opas said the patient was found to have a fever, with blisters and a rash that began in his groin area before spreading to other parts of his body. The symptoms coincided with information from the World Health Organisation, that blisters and rashes are found around the genitalia of 98% of those infected, and most of them are homosexual or bisexual.

Dr Kusak confirmed that the German patient arrived in Phuket with his Thai wife on July 18. He was not a homosexual or bisexual, he said.

While in Phuket, they had stayed with his wife's family in Muang district. The couple had gone out sightseeing but had not visited any entertainment venues.

Dr Kusak confirmed that the German patient arrived in Phuket with his Thai wife on July 18. He was not a homosexual or bisexual, he said.

While in Phuket, they had stayed with his wife's family in Muang district. The couple had gone out sightseeing but had not visited any entertainment venues.

[spoon]

21 days incubation is the high end. The range ive read froma quick google is 5-21 days, while it is usually within 6-13 days. 

[tassojunior]

DC has the highest % of monkeypox in the US so I got my shot yesterday. In DC you register online and my appointment choice was sent to me in 2 days. Tiny needle. They said ideally get a 2nd shot in 30 days. 

24 hrs and no reaction so I'll now schedule my 2nd covid booster.

 

[xpaulo]

An announcer on Canadian news was saying yesterday monkey pox is now known to be most associated with a specific sexual act. But it's Canada and its anglophone media is reluctant say or show anything that might disturb somebody. The francophone media seems to be better about telling people the truth. Anyway, does anybody know which sexual act is more associated with monkey pox. I live in a semi-rural area and there will be no monkey pox vaccinations in the near future.... I don't know how many people on here remember the sitcom Soap and the visiting relative.. "we don't have queers in Texas." That's what it feels like sometimes. I want to travel this winter and advising gay guys not to have sex when they're travelling is like well, telling them not to breathe. Can't wait to hear the officials tell single straight guys not to have sex. Also frustrating because guys are crossing over to Vancouver from Seattle to get the vaccinations, but in some other parts of the country only a relative handful of people are eligible for vaccinations.... ie they have had to had close contact with a confirmed case.

Edited August 4, 2022 by xpaulo
Typo

[tassojunior]

Just what we need after HIV and Covid. Another reason to not have sex. No wonder so few guys are getting into the business. If you thought the CDC was over the top on masks and covid, here's their "Don't Have Sex!" MonkeyPox advice:

https://www.cdc.gov/poxvirus/monkeypox/sexualhealth/index.html

 

[belkinDC]

46 minutes ago, tassojunior said:

Just what we need after HIV and Covid. Another reason to not have sex. No wonder so few guys are getting into the business. If you thought the CDC was over the top on masks and covid, here's their "Don't Have Sex!" MonkeyPox advice:

https://www.cdc.gov/poxvirus/monkeypox/sexualhealth/index.html

 

Hardly over the top to advise against having sex if one knows or suspects that oneself or one’s prospective partner has monkeypox?

[belkinDC]

https://www.nytimes.com/2022/08/03/us/politics/monkeypox-vaccine-doses-us.html

U.S. Could Have Had Many More Doses of Monkeypox Vaccine This Year

The Department of Health and Human Services delayed asking the manufacturer to process the bulk vaccine the government already owned into vials.
 

By Sharon LaFraniere, Noah Weiland and Joseph Goldstein

Aug. 3, 2022

WASHINGTON — 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.

But it could now. Some states are trying to stretch out doses by giving recipients only one shot of the two-dose vaccine. California, Illinois and New York have declared public health emergencies. In New York City, every available slot for a monkeypox shot is taken.

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.

The government also owns the equivalent of about 16.5 million doses of bulk vaccine produced and stored by Bavarian Nordic. But by the time the health agency ordered 500,000 doses worth to be vialed on June 10, other countries with outbreaks had submitted their own orders and the earliest delivery date was October.

Another order for 110,000 doses for European nations soon followed. When the United States came back with two more orders of 2.5 million doses each on July 1 and July 15, the bulk could only be delivered next year.

Mr. Gostin, who now directs the O’Neill Institute for National and Global Health Law at Georgetown University, predicted that President Biden’s decision to appoint two new monkeypox response coordinators would help “light a fire” under federal health agencies. The White House announced Tuesday that Robert Fenton, an administrator at the Federal Emergency Management Agency, and Dr. Demetre Daskalakis, a C.D.C. official, will lead the response.

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.”

Two senior federal officials, who requested anonymity in order to speak frankly, said Mr. Biden is upset by the vaccine shortage. His administration has often touted its success delivering hundreds of millions of coronavirus shots to Americans, and is stung by criticism that a lack of foresight and management has left gay men — the prime risk group for monkeypox — unprotected.

Some critics blame a failure of leadership at the Health and Human Services Department, saying the department’s secretary, Xavier Becerra, has taken a hands-off approach to an increasingly serious situation. His department not only oversees both the C.D.C. and the Food and Drug Administration, but also runs the Biomedical Advanced Research and Development Authority, or BARDA, which helps develop and buys vaccines, tests and treatments to protect against highly contagious viruses, bioterrorism and other hazards.

During a press call on monkeypox last week, Mr. Becerra said his department is doing all it can to ensure that “we not only stay ahead of this virus but that we end this outbreak.” He noted that he had recently elevated the agency’s Office of Strategic Preparedness and Response so it can respond more quickly to public health emergencies.

Sarah Lovenheim, the department’s chief spokeswoman, said in a statement: “Our response has accelerated to meet evolving needs on the ground, and it will keep accelerating. We will use every lever possible to continue allocating doses ahead of timelines, as possible.”

So far, according to the C.D.C., 6,326 cases of monkeypox have been reported. For now, the virus is spreading almost entirely among gay and bisexual men, and those with multiple or anonymous partners are considered especially at risk. Mr. Becerra noted that while more than a million Americans have died of Covid-19, no one in the United States has died of monkeypox.

The official case count is widely considered an underestimate. Not only is testing limited, but public health officials like Dr. Joseph Kanter, the top medical official in Louisiana, said that monkeypox can be hard to diagnose. “It can be one or two solitary lesions, so if it’s not on a clinician’s radar,” he said, it can be missed.

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.

Bavarian Nordic was able to develop the vaccine, which also works against smallpox, largely thanks to the federal government’s backing, which surpassed $1 billion in 2014 and is now edging toward $2 billion. Dawn O’Connell, the federal health agency’s assistant secretary for preparedness and response, told reporters in early June: “The world has Jynneos because we invested in it.”

The company opened a new $75 million fill-and-finish plant in 2021 that is now bottling as many as 200,000 to 300,000 doses a week. At the time, the United States was counting on Jynneos to protect against smallpox, not monkeypox, and the government had a large stockpile of another effective smallpox vaccine. No F.D.A. inspection was scheduled until after the monkeypox outbreak, and it did not conclude until July 27.

In early June, Health and Human Services officials agreed to essentially loan back about 215,000 finished doses of vaccine to Bavarian Nordic so the firm could supply them to European countries that were suffering outbreaks.

“It didn’t make sense while we were waiting for F.D.A. to get the inspection done — which is coming — that we sit on doses that our international colleagues in Europe could actually use,” Ms. O’Connell said on June 10. Now the government is trying to reschedule delivery of those doses for later this year, a company spokesman said.

The final stage of putting the liquid vaccine into vials accounts for a substantial share of the cost of vaccine production. Some federal officials say the health department was slow to submit its orders for that work because officials at BARDA argued they were short on funds.

When the demand for vaccines became an outcry, though, the agency found the money to pay for five million more doses to be vialed. Officials are now contemplating shifting half the work to another firm that may be able to finish and fill doses more than twice as fast.

Some experts say it can take as long as six to nine months for a plant to gear up to handle a vaccine like Jynneos, which contains a live virus in a weakened state. Carlo de Notaristefani, who oversaw coronavirus vaccine manufacturing for the federal government until last year, said that such factories must operate at a high “biological safety level,” including a fully enclosed, segregated manufacturing line.

But he and other experts said it should be possible to streamline the transfer of Bavarian Nordic’s process so another plant could be ready in about three months. A company spokesperson said Bavarian Nordic agreed to pay $10 million of the cost of such a transfer after federal officials said they did not have the budget for it.

Kitty Bennett contributed research.

[tassojunior]

1 hour ago, belkinDC said:

Hardly over the top to advise against having sex if one knows or suspects that oneself or one’s prospective partner has monkeypox?

Except in practice that leads to how you know someone does not have Monkeypox. Best course, no sex. 

[reader]

From Bangkok Post

Fourth monkeypox case found in Bangkok

Thailand's fourth case of monkeypox has been confirmed in Bangkok on Friday. The patient is a woman with a record of visiting entertainment venues popular with foreign tourists.

Department of Disease Control director-general Opas Karnkawinpong said on Friday that the latest case is a 22-year-old woman who regularly visited areas at risk of monkeypox transmission. 

He said the woman developed a fever on July 29 but still visited entertainment places in Bangkok with her Thai and foreign friends. On July 30, she started to have blisters on her arms and legs before they spread to her sexual organ and other body parts. 

On Wednesday, the woman sought treatment at a hospital in Samut Prakan. Results of laboratory tests conducted by the Medical Sciences Department and Chulalongkorn University’s Faculty of Medicine indicated that she had been infected with monkeypox on Thursday. 

Dr Opas said he had instructed the 6th Disease Control Office in Chon Buri to work closely with the Institute for Urban Disease Control and Prevention and the Bangkok Metropolitan Administration’s Health Department to trace down those who were in close contact with the woman, including two of her roommates.

The health official stressed that the monkeypox disease does not spread easily between people.

[Riobard]

São Paulo and Rio de Janeiro represent the majority of new MPXV cases in Brazil and they are certainly multiplying. It would be expected to at least quadruple within a month.

They can only launch infection treatment preparedness and containment measures at this time. About 30,000 and 20,000 vaccine doses are ordered with expected delivery, respectively, September and November. At those low supply numbers one wonders if it will be released for PEP only (& PrEP for health care workers) at that time, and what will be the uptake comfort level among GBMSM that may need to self-identify risk, already a factor that compromises HIV PrEP uptake. Hospitals will have limited capacity for a second disease this decade requiring structural patient isolation. 

Don’t be shocked if there is no choice but to shut down congregate sexual venues, in case you are planning to visit and utilize them.

———

https://agenciabrasil.ebc.com.br/saude/noticia/2022-08/sao-paulo-lanca-plano-de-enfrentamento-variola-dos-macacos?amp

——-

[Mavica]

10 hours ago, Riobard said:

Don’t be shocked if there is no choice but to shut down congregate sexual venues, in case you are planning to visit and utilize them.

I've been toying with a return visit to Rio.  However, probably not until the pox risk diminishes ... particularly so because I'd be spending time in the saunas.  I feel similarly about visiting (primarily for sex purposes) other destinations.

[belkinDC]

New York Times
Biden Administration to Allow New Injection Method for Monkeypox Vaccine

The approach — injecting one-fifth of the current dose into the skin instead of a full dose into underlying fat — would help stretch out the nation’s limited supply of vaccine.

By Sharon LaFraniere and Noah Weiland

Aug. 8, 2022, 9:43 p.m. ET

WASHINGTON — The Biden administration has decided to stretch out its limited supply of monkeypox vaccine by allowing a different method of injection that uses one-fifth as much per shot, according to senior administration officials familiar with the planning.

In order for the Food and Drug Administration to authorize so-called intradermal injection, which would involve injecting one-fifth of the current dose into the skin instead of a full dose into underlying fat, the Department of Health and Human Services will need to issue a new emergency declaration allowing regulators to invoke the F.D.A.’s emergency use powers. That declaration is expected as early as Tuesday afternoon.

The move would help alleviate a shortage of vaccine that has turned into a growing political and public health problem for the administration.

The administration has faced a barrage of criticism that it was too slow to ship vaccine that was ready for use to the United States from Denmark, where it was manufactured, and too slow to order that bulk vaccine stocks be processed into vials after the disease first surfaced here in mid-May.

In less than three months, more than 8,900 monkeypox cases have been reported. The disease spreads primarily through skin-to-skin contact during sex among gay and bisexual men. Federal officials are concerned about both the current infection rate and the risk that the disease could spread to other parts of the population.

Even though it invested more than $1 billion in developing the two-dose vaccine known as Jynneos that works against both monkeypox and smallpox, the government has only 1.1 million shots on hand. It needs about three times as many doses to cover the 1.6 million to 1.7 million Americans who, according to the Centers for Disease Control and Prevention, are at high risk of contracting monkeypox.

Federal health officials said last week that so far, they have distributed about 600,000 doses of the vaccine to state and local jurisdictions.

The Department of Health and Human Services last week issued a broader public emergency declaration that allowed the federal government to more easily allot money and other resources to fight the virus.

Research on intradermal injection of the monkeypox vaccine is essentially limited to one study. It showed that when the vaccine was injected between skin layers, it induced an immune response comparable to that from a standard injection into the fat underneath the skin. Federal officials have consulted with a variety of outside groups about switching to the intradermal injection approach, including the Infectious Diseases Society of America, according to people familiar with the talks.

Some outside experts have criticized the data backing up the method for monkeypox as too thin and narrowly focused. The government’s decision to go with it is heavily based on a 2015 study that was sponsored by the National Institutes of Health.

Dr. John Beigel, an N.I.H. associate director of clinical research who has briefed federal health officials and the World Health Organization, said that switching to the intradermal method was a better option for preserving vaccine than administering just one of the two recommended doses, as some jurisdictions now do. One shot does not prompt nearly as strong an immune response as two, he said.

“The upside is you can stretch out doses,” said John P. Moore, a virologist at Weill Cornell Medicine. “The downside is, if you cut it too far or take too many liberties, you reduce the efficacy. And how are you going to know that? It’s educated guesswork.”

The intradermal method can be complicated for vaccinators, who must guide a needle into a thin space. If a vaccinator goes too deep and inserts the dose into fat, the patient might not receive enough vaccine, experts say. But if the needle is not inserted far enough, some of the vaccine could leak back out.

Such shots typically induce more redness and swelling, but are less painful than a standard injection, the 2015 study showed.

They have previously been used in polio vaccination campaigns, for rabies and with tuberculosis skin tests.

The National Institutes of Health had planned further studies into how well such shots work with the monkeypox vaccine, but the results were not expected until the late fall or early winter. Over the weekend, top federal officials came to a consensus that the government needed to embrace the approach now.

[JKane]

For what it's worth I got the 1st shot from Los Angeles County this weekend.  Wait was a bit long, opted out of the 15 minutes more of observation after, no side effects.  It's a 2-shot vax, hoping they'll have their shit together a little more when it's time for the second.  

[reader]

From Thai News Service

5th Monkeypox Case

BANGKOK, Aug 15 (TNA) – Thailand has its fifth monkeypox case who is a Thai woman returning from Dubai, according to the Department of Disease Control.

Dr Opas Karnkawinpong, director-general of the department, said the Thai woman aged 25 years arrived at Suvarnabhumi airport on Aug 14.

She was sick and detected by disease control officials at the airport. The woman was cooperative with the officials.

Dr Opas said that she had blisters on her body and tested positive for monkeypox. She was sent to hospital for treatment.

No one was in close contact with her except two foreign passengers who sat next to her on the plane. Officials were following the foreigners in accordance with their surveillance measures, the director-general said.

Monkeypox was not easily transmitted through shared meals or breathing. Infection needed very close contact which was not limited to intercourse, he said.

There were more than 30,000 monkeypox cases worldwide and only about six of them died of the disease, Dr Opas said. (TNA)

 

[Guest]

On 8/5/2022 at 5:32 PM, Riobard said:

Don’t be shocked if there is no choice but to shut down congregate sexual venues, in case you are planning to visit and utilize them.

agree 

Additionally, European friends are saying Mpox more widespread than being counted/reported (Germany & Spain to be specific) and there is a belief it is more contagious than described in media. Comments from guys that travel for bear scene events is that people returned home w either syphilis, Covid or Monkeypox. 

Even w Jynneos vax, I would not go to sauna now or engage w sex-workers.  First superspreader site in Madrid (apart from the original superspreader event in Canary Islands) was at a sauna.

85% efficient means still possible to get it and in current risk/reward scenario, not worth it.  I’ve seen the pictures and read the stories.  It’s bad.

[reader]

The WHO is reporting a 20% increase in new infections in the past week. There are now over 35,000 cases worldwide.

Excerpted from CNBC

Though data on the vaccine’s effectiveness is limited, there are reports of breakthrough cases in which people who received the shots after exposure to the virus are still falling ill as well as individuals becoming infected after receiving the vaccine as a preventative measure, according to Dr. Rosamund Lewis, the WHO’s monkeypox technical lead.

“We have known from the beginning that this vaccine would not be a silver bullet, that it would not meet all the expectations that are being put on it, and that we don’t have firm efficacy data or effectiveness data in this context,” Lewis told reporters.

These reports are not surprising, Lewis said, but highlight the importance of individuals taking other precautions such as reducing their number of sexual partners and avoiding group or casual sex during the current outbreak. It’s also important for people to know that their immune system does not reach its peak response until two weeks after the second dose, she said.

“People do need to wait until the vaccine can generate a maximum immune response, but we don’t yet know what the effectiveness will be overall,” Lewis said. A small study from the 1980s found that the smallpox vaccines available at the time were 85% effective at preventing monkeypox. Jynneos was approved in the U.S. in 2019 to treat both smallpox and monkeypox, which are in the same virus family.

[Guest]

an excellent article in Washington Post about the American failure re: Monkeypox & where it’s headed.

Inside America’s monkeypox crisis — and the mistakes that made it worse

Early mistakes by the Biden administration left hundreds of thousands of gay men facing the threat of an agonizing illness and the potential for broader circulation of monkeypox.

By Dan Diamond, Fenit Nirappil and Lena H. Sun

 

https://www.washingtonpost.com/health/2022/08/17/monkeypox-biden-vaccine-testing-mistakes/

 

Download The Washington Post app.

[reader]

From Politico

CDC vows a revamp after backlash to pandemic response

The Centers for Disease Control and Prevention is undergoing an overhaul following criticism of how it handled the coronavirus pandemic and, more recently, a growing monkeypox outbreak, reports your Pulse co-author, Krista.

Federal regulators conducted reviews of the agency and determined that the “traditional scientific and communication processes were not adequate to effectively respond to a crisis the size and scope of the COVID-19 pandemic,” according to an agency statement.

As a result, CDC Director Rochelle Walensky wants to “transform” the agency and its work culture by improving how the agency shares information, develops public health guidance and communicates with the American public. The CDC didn’t provide a timeline for the revamp.

Walensky appointed HHS Deputy Secretary Mary Wakefield to oversee a team charged with ensuring the changes are made. Wakefield is also tasked with setting up a new executive council that will “determine agency priorities, track progress and align budget decisions, with a bias toward public health impact.”

• An equity office will be established to improve the agency’s diversity across the organization, from hiring to policy.
• The CDC website will be revamped and streamlined to simplify its public health guidance.
• The agency will give staff incentives to gear their data and research toward public health policy action instead of scientific publications. In addition, measures to speed up the publication of data and research findings are being considered.
• Additional staff will be trained to quickly respond to public health emergencies. Emergency staffing will be set up to ensure there are no personnel gaps during a crisis.

[Mavica]

20 hours ago, Slvkguy said:

an excellent article in Washington Post about the American failure re: Monkeypox & where it’s headed.

Inside America’s monkeypox crisis — and the mistakes that made it worse

Early mistakes by the Biden administration left hundreds of thousands of gay men facing the threat of an agonizing illness and the potential for broader circulation of monkeypox.

By Dan Diamond, Fenit Nirappil and Lena H. Sun

 

https://www.washingtonpost.com/health/2022/08/17/monkeypox-biden-vaccine-testing-mistakes/

 

Download The Washington Post app.

Just who is it, which government worldwide anticipated, the appearance of Monkeypox?  Biden?  Ignorant to suggest that, by anyone.  Listen, many gays aren't old enough to have lived through HIV/AIDS.  Stop the dangerous behavior and the infections will not spread as quickly.  We are responsible for our health, not the "government."

[Lonnie]

13 hours ago, reader said:

CDC vows a revamp

1 million dead...it's about time. Do better with monkey pox...please.

[belkinDC]

12 hours ago, Mavica said:

Just who is it, which government worldwide anticipated, the appearance of Monkeypox?  Biden?  Ignorant to suggest that, by anyone.  Listen, many gays aren't old enough to have lived through HIV/AIDS.  Stop the dangerous behavior and the infections will not spread as quickly.  We are responsible for our health, not the "government."

The re-emergence of an orthopoxvirus has in fact been contemplated and planned for by the US federal government for over a decade, which is why there is/was a stockpile of Jynneos and ACAM. At one point we had 20 million doses of Jynneos in the stockpile, which the government let expire without replacing them. That is indeed a failure and we would have been much better prepared for this outbreak if the stockpile had been maintained at those levels.

[belkinDC]

43 minutes ago, belkinDC said:

The re-emergence of an orthopoxvirus has in fact been contemplated and planned for by the US federal government for over a decade, which is why there is/was a stockpile of Jynneos and ACAM. At one point we had 20 million doses of Jynneos in the stockpile, which the government let expire without replacing them. That is indeed a failure and we would have been much better prepared for this outbreak if the stockpile had been maintained at those levels.

More on this point from Politico:

https://www.politico.com/news/2022/08/18/u-s-officials-knew-for-years-they-did-not-have-enough-jynneos-vaccine-00052694

Before monkeypox outbreak, U.S. officials knew for years they didn't have enough of key shot

 

The Strategic National Stockpile was supposed to have about 120 million Jynneos doses, enough for 60 million people, | Mario Tama/Getty Images

By ERIN BANCO and HELEN COLLIS

08/18/2022 03:31 PM EDT

Updated: 08/18/2022 06:26 PM EDT

Officials said the Strategic National Stockpile did not have enough Jynneos doses for a potential smallpox outbreak because of a lack of resources.

Top U.S. health officials have known for years that the country’s Strategic National Stockpile did not have enough doses of a smallpox vaccine that is now key to the monkeypox fight, according to three former senior officials and a current official working on the monkeypox response.

The U.S. has stockpiled Jynneos, the vaccine by Bavarian Nordic, which is also being used to combat monkeypox.

The U.S. never had the money to purchase the millions of doses that experts felt were necessary, the officials said. Now, that shortfall is hampering efforts to contain the growing monkeypox outbreak, one in which the Biden administration has come under fire for failing to deliver enough vaccine for the millions of people at risk.

“Every time I meet a member of Congress, I let them know what the need is,” said Dawn O’Connell, head of the Administration for Strategic Preparedness and Response, in an interview. “The SNS … has been chronically underfunded. We need to get this SNS fully funded and stocked against what we think the next threats are.”

The Strategic National Stockpile was supposed to have about 120 million Jynneos doses, enough for 60 million people, said the officials who were granted anonymity to discuss sensitive government matters. Jynneos was stockpiled as an alternative to ACAM 2000, a different vaccine that is not suitable for people who are immunocompromised. Prior to 2019, the U.S. had just 20 million doses. In 2020, the U.S. purchased just over 1 million doses to replenish expired vaccine.

Paul Chaplin, CEO of Bavarian Nordic, told POLITICO on Thursday that after the vaccine received approval from the Food and Drug Administration in 2019, the U.S. stockpile requirement called for the protection of 66 million at-risk Americans. That meant about 132 million doses of the Jynneos shot were needed for people who cannot receive ACAM 2000 in the event of a smallpox outbreak.

“That’s people [who] are vulnerable who shouldn’t really receive first and second generation vaccines,” Chaplin said.

An official at the Department of Health and Human Services suggested the 120 million dose figure was higher than the government threshold but did not dispute that the Jynneos stockpile level was below what it should have been, and declined to provide what the SNS requirements actually say.

The senior officials who spoke to POLITICO said the requirements for the stockpile — levels set in part by HHS — often shift and are, at times, outdated. For example, one former senior official said the department kept two numbers on hand — the number of doses the stockpile could afford to purchase and the number of doses that were actually needed to distribute to a certain population. The number of Jynneos doses the government could afford as of 2019, that official said, was around 40 million. But money for Jynneos shots competed with funding for more pressing priorities and threats the administration perceived as more likely.

“That’s not preparedness,” said the former senior health official. “It’s like telling the military … you have a requirement for 100 airplanes, but we’re only gonna give you 10 because that’s all we can afford. And then we have to fight. Good luck.”

Since the Biden administration assumed office, there have been ongoing discussions within the ASPR about adjusting the requirement levels and about how to get additional funding to help ramp up supply of critical medicines and shots.

In November 2021, senior officials from HHS and the Centers for Disease Control and Prevention held a meeting to discuss responses to a potential smallpox outbreak. Officials there spoke about the Jynneos shot and noted many doses had previously expired. They planned to ask Congress for additional funding to shore up supply, according to one of the former officials who attended the meeting.

“There was a push after that to get hard, concrete numbers and budget numbers because they didn’t want to report … this huge gap [in supply] back to the White House,” one of the officials said.

In May of 2021, POLITICO reported that the Biden administration rerouted $2 billion from the SNS to help handle the surge of unaccompanied migrants at the border. In its most recent budget request, ASPR asked for $975 million in funds for the stockpile, about $130 million more than was enacted in 2022.

“We all saw what happened in 2020 when the PPE we expected to be there wasn’t there. I think Congress felt that acutely as well when their constituents were searching for things,” O’Connell said. “So it is really important for me to use that as a critical example of why we need to move forward and make sure the SNS is well funded against the current material threats.”

[Mavica]

9 hours ago, belkinDC said:

The re-emergence of an orthopoxvirus has in fact been contemplated and planned for by the US federal government for over a decade, which is why there is/was a stockpile of Jynneos and ACAM. At one point we had 20 million doses of Jynneos in the stockpile, which the government let expire without replacing them. That is indeed a failure and we would have been much better prepared for this outbreak if the stockpile had been maintained at those levels.

Thank you for the comments, and the link to the Politico article in another posting. 

Strategic supplies of Smallpox vaccines and the relatively recent Jynneos vaccine (with a cross use for Monkeypox) have been underfunded for decades.  Jynneos was not approved for use in the USA until late-September 2019 - about 3 years ago.  Recently published reports say first confirmed cases of Monkeypox in the USA occurred in July and November 2021, though it was presented in certain areas of Africa long before then.  Remember, too, that Smallpox was not considered a health threat in the USA, Monkeypox was not considered a real threat yet and the funding for certain stockpiles was redirected to other emerging priorities.

Though certain specialized segments / teams in a couple of US Federal health agencies knew of Monkeypox in Africa (maybe elsewhere), I think it's an exaggeration to say the "US federal government" knew of the risk to the USA "for over a decade."  Were concerns passed along to the senior officials in the Executive Branch, or the U.S. Congress?  I read many news sources daily and I don't recall reading or hearing the name "Monkeypox" before a couple or several months ago.  And given the focus on COVID the past couple of years I'll suggest there was an understandable preoccupation with responding to that pandemic ... by national leaders.

President Biden has been in office less than 2 years, so placing blame at his feet for a shortage of Smallpox or the additional vaccine which was approved 9 months after his ascent to the Presidency, is misplaced.

Segments of the gay community can help to substantially slow the spread of Monkeypox.  For that to happen requires a change in behavior, and there are gay men who I sense will refuse to make that change.  A change of behavior is what led to, but was not solely responsible for, the proliferation of HIV and the tragic deaths of so many gay men ... and others.  We read comments on these forums from gay men who engage in high risk behavior.  And those who do that endanger many more of us.

Thank you for your comments and further information.

 

[belkinDC]

1 hour ago, Mavica said:

Strategic supplies of Smallpox vaccines and the relatively recent Jynneos vaccine (with a cross use for Monkeypox) have been underfunded for decades.

That's precisely my point. Yes - nobody knew that Monkeypox would emerge in late Spring 2022 and failed to prepare for that precise eventuality. But the risk of a smallpox attack - or some other orthopoxvirus emergence -- has long been a known risk. As the Politico articles notes, I should rather have said over two decades rather than over a decade that the need to stockpile smallpox vaccines has been a known need. 

I am not blaming Biden or his Administration exclusively but also and at least as much the US Congress for failing to properly fund our stockpile of medical countermeasures.

1 hour ago, Mavica said:

And given the focus on COVID the past couple of years I'll suggest there was an understandable preoccupation with responding to that pandemic ... by national leaders.

I would suggest that if anything Congress failed to learn the lessons of COVID and makes our lack of preparation for monkeypox even more frustrating... when the shit hit the fan and tons of the PPE and ventilators that we had in the Strategic National Stockpile were found to be unusable, due to years of underinvestment and failing to maintain the stockpile, it should have been a wakeup call.

Out of the 6 trillion or so spent on COVID-response writ large, they couldn't have found a few billion (or tens) here or there to beef up the procurement and R&D of biodefense medical countermeasures?
 

1 hour ago, Mavica said:

President Biden has been in office less than 2 years, so placing blame at his feet for a shortage of Smallpox or the additional vaccine which was approved 9 months after his ascent to the Presidency, is misplaced.

As I said, I place at least as much blame on Congress. And not to nitpick, but it was approved 16 months before his inauguration rather than 9 months after.

 

1 hour ago, Mavica said:

Segments of the gay community can help to substantially slow the spread of Monkeypox.

No argument from me on this point. Behavior modification should absolutely be part of the solution, and I think the decision of certain event/party planners to go through with big gatherings despite the risk and lack of vaccines was reprehensible.

[Guest]

49 minutes ago, belkinDC said:

I am not blaming Biden or his Administration exclusively but also and at least as much the US Congress for failing to properly fund our stockpile of medical countermeasures

The Biden Administration is clearly responsible for the American failure re: monkeypox.  We don’t get to excuse those we voted for and only blame the ones we didn’t.  

The richest country in the world and we can’t seem to get much right.