POST 264. July 28, 2022. Monkeypox. “The federal response to monkeypox, including the limited testing capacity, has echoes of how public health authorities initially mismanaged Covid-19.”

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“The Biden administration privately estimated to Congress this month that it may need nearly $7 billion to mount a response to the nation’s monkeypox outbreak that matches “the scope and urgency of the current situation.”…

The Biden administration also called for as much as $31.4 billion in new funds to combat the coronavirus pandemic, as it seeks to ensure the government has the resources necessary to purchase more treatments, testing and vaccines this year.

The private discussions have unfolded as public health experts warn that monkeypox, which can spread by skin-to-skin contact and cause fever, lesions and severe pain, is at risk of becoming permanently entrenched in the United States. Federal officials have identified about 3,500 cases, overwhelmingly among gay and bisexual men, and have warned that the virus is likely to spread to broader populations…

According to the memo obtained by The Post, officials estimate that $6.9 billion in new funding for the monkeypox response would allow the Department of Health and Human Services to support “domestic end-to-end vaccine manufacturing capacity and technology transfer” in the United States. The only vaccine specifically approved by the Food and Drug Administration for monkeypox, Jynneos, is produced in Denmark, which has caused significant complications in the U.S. response — for instance, hundreds of thousands of Jynneos doses were stranded overseas for weeks, awaiting U.S. inspection and transport.

With that much funding, officials further estimate that they would be able to secure 19 million new doses of vaccine for monkeypox and replenish about 4 million doses for paused smallpox preparedness efforts, as well as purchase more antiviral treatments, expand testing, improve vaccine distribution, and provide coverage of services for uninsured and underinsured Americans, among other goals.

Health officials also estimated the effects of a “medium” second option, seeking $2.2 billion in monkeypox funding to purchase some vaccine doses and treatments that would be targeted toward the gay and bisexual community, where the outbreak is currently concentrated. But the amount may only provide an effective response if the outbreak remains contained and does not spill into broader populations, “which is not guaranteed,” the memo cautions.

Officials also estimated a bare-bones fallback option of $500 million that would allow for purchasing some vaccine doses and continuing “minimal” operations.

Health officials have said they are funding the current monkeypox response by drawing on existing appropriations and a response fund maintained by the Centers for Disease Control and Prevention. The Biden administration has distributed 330,000 vaccine doses and contracted for a total of 6.9 million Jynneos doses by mid-2023, in addition to other investments in tests and treatments.”  (A)

“More than 3,800 monkeypox cases have been reported in the US, the most of any country around the globe, government health data shows.

The rising number of cases has reportedly prompted the Biden administration to mull declaring a national health emergency.

The virus has already been classified as a global health emergency by the World Health Organization (WHO).

To date, more than 18,000 cases have been reported in 75 countries.

According to data published online by the US Centers for Disease Control and Prevention (CDC), as of 25 July there were 3,846 confirmed or suspected monkeypox cases in the US…

With cases in the US rising, the Washington Post on 25 July reported that the Biden administration was considering declaring a public health emergency.

The measure would allow the government to use federal funds to combat the outbreak, raise public awareness and better collect relevant health data.

Additionally, the administration is reportedly preparing to name a coordinator to oversee the government’s response to monkeypox from the White House…

The US response to the virus has so far been plagued by vaccine shortages and a slow start to testing, leading some to compare the situation to the beginning of the Covid-19 pandemic in early 2020.

In Washington DC, for example, officials have warned that a “rapid increase in cases”, coupled with a “very limited” supply of vaccines, means that authorities must prioritise high-risk residents.”  (B)

“There are now more than 1,000 confirmed cases of monkeypox in New York City, which continues to be a hotspot for the virus, health officials said on Monday.

New York reached 1,040 cases as of Monday, said the most recent information released by the city. That accounts for about a quarter of all of the confirmed cases in the US…

The virus is spreading primarily among men who have sex with men, research has shown. Close sexual contact was responsible for transmission in 95% of cases, one recent study found.

There is a divide in New York City’s health department over whether the agency should advise gay men to change their sexual behavior amid the outbreak.

Even as cases in New York have surged, officials have struggled to respond with adequate vaccination and testing. At the end of June, as New Yorkers scrambled to get a limited supply of monkeypox vaccines, there were 300,000 doses sitting in a warehouse in Denmark, the New York Times reported on Monday. Then, once officials decided to send those doses to the US, they arrived slowly, missing a chance to slow the spread of the virus.

New York’s governor, Kathy Hochul, also announced on Monday that the state had reached an agreement with Quest Diagnostics to use a PCR test on people who have a rash consistent with monkeypox.

“The real challenge with testing is that it involves swabbing lesions, which must be present for the test to assess whether the virus is also present,” the New York state health commissioner, Mary Bassett, said in a statement. “Without lesions, testing is not currently possible. And we will continue working to make sure providers know when and how to test for monkeypox.” (C)

“On the Thursday before Pride Weekend last month, hundreds of men dropped what they were doing and raced to a city-run health clinic in Manhattan. Finally, more than a month after monkeypox appeared in New York City, a vaccine was being made available to sexually active gay and bisexual men, among whom the virus was rapidly spreading.

But there was a catch: There were only 1,000 doses available. Within two hours, the only clinic offering the shots began turning people away.

At that same moment, some 300,000 doses of a ready-to-use vaccine owned by the United States sat in a facility in Denmark. American officials had waited weeks as the virus spread in New York and beyond before deciding to ship those doses to the United States.

Even then, there was little apparent urgency: The doses were flown piecemeal, arriving over the span of two weeks. Many didn’t arrive until July, more than six weeks after the first case was identified in New York City.

By holding back the doses, an early opportunity to contain or slow the largest monkeypox outbreak in the country appears to have slipped by. On Saturday, the World Health Organization declared monkeypox a global health emergency. At least 16,000 cases have been reported around the world, with about 3,000 in the United States. Infections in New York City make up nearly a third of the national case count.

The federal response to monkeypox, including the limited testing capacity, has echoes of how public health authorities initially mismanaged Covid-19.

With monkeypox, however, the federal government had a powerful tool to slow the spread from the start: an effective vaccine.

Yet the government was slow to deploy the vaccine, which was originally developed and stockpiled for use against smallpox, activists say…

The United States also owned well over a million Jynneos doses in vials ready for use — and enough vaccine for millions of more doses that had yet to be filled into vials — in Denmark, where the producer of the vaccine, Bavarian Nordic, is headquartered.

Much of that supply was tied up in bureaucratic red tape because the Food and Drug Administration had yet to inspect and certify a new facility outside Copenhagen where the company now fills the vaccine into vials — an issue that has yet to be fully resolved.

But there were 372,000 doses owned by the United States that were ready to go. These doses, stored at the company’s headquarters, had been filled into vials earlier, at a different facility with the necessary F.D.A. approval.

Rather than quickly transfer those doses back to the United States and begin administering them, however, the federal government adopted a wait-and-see attitude. In the first few weeks after monkeypox was detected in the United States, the government requested only 72,000 of the 372,000 doses…

One reason that federal officials were reluctant to order all available doses early on involved cold storage and shelf life. The storage facilities in America where the doses would be kept weren’t as cold as the Denmark facility, said Dr. Disbrow, a senior official at the Department of Health and Human Services who runs BARDA.

“So if all the doses were not necessary for the outbreak,” he said, “their shelf life would be dramatically shortened.”

Joseph Osmundson, a microbiologist and queer activist, said that the monkeypox outbreak may not have been the emergency that the federal government had prepared for — weaponized smallpox — “but this is an emergency nevertheless.”

The first monkeypox case to be detected in the United States this year was identified in Massachusetts on May 18. New York City identified a case the next day. On May 20, BARDA requested that Bavarian Nordic send over 36,000 doses, a spokeswoman for the agency said. They arrived five days later.

On May 27, BARDA requested another 36,000 doses, which arrived two weeks later, Dr. Disbrow said. By then, 16 cases of monkeypox had been detected in New York City, along with cases in 14 other states and the District of Columbia.

Dr. Disbrow said that only so many doses could be transported per flight. In an email, a spokesman for Bavarian Nordic explained that each large order required some lead time. The company had to first receive a container, known as a cocoon, from the shippers and then “freeze them to temperature for five days” before packing it with vaccine.

As of June 10, the federal government had distributed just a few thousand doses of monkeypox vaccines to states, officials said in a call that day with reporters. A senior Health and Human Services official, Dawn O’Connell, said the United States would receive 300,000 doses of Jynneos “over the next several weeks.”  (D)

“Gov. Phil Murphy is asking President Joe Biden’s administration for more vaccines against monkeypox as the number of cases in New Jersey continues to climb and access to the vaccine has grown scarce.

The governor and the state’s top health official said in a letter to federal officials that New Jersey isn’t getting its fair share of vaccines given what they estimate the state will need to protect people and stop the spread of the disease.

New Jersey expects to receive nearly 2,700 additional doses this week, according to the state Department of Health. That — which is in addition to the 2,800 doses the state was already sent — accounts for 2.06% of the federal government’s 131,000 available doses being sent out, according to a letter they sent to the U.S. Department of Health & Human Services and Centers for Disease Control and Prevention.

“We do not believe that New Jersey has received an equitable percentage of available vaccine through this allocation strategy,” Murphy and state Health Commissioner Judith Persichilli wrote in their letter. “I would like to request that HHS and the CDC reconsider the allocation strategy and increase New Jersey’s vaccine allocation to account for our population size and considerations raised in this letter.”

It was sent as the number of confirmed monkeypox cases has climbed to 102 people. Neighboring New York has the highest number of cases in the nation — 900 people — according to the CDC.

“It’s a free-for-all across the state and across the country,” Perry Halkitis, dean of the Rutgers School of Public Health, said about getting a shot…

According to a study on monkeypox infections across 16 countries released last week by the New England Journal of Medicine, 98% of the people infected were gay or bisexual men.

“A lot of it is making the hair stand up on the back of my neck,” Halkitis said. “There’s got to be some bottom line homophobia here.”

And while the head of the World Health Organization said Wednesday that at-risk men should reduce their sexual partners “for the moment,” Halkitis was quick to say this is not a “gay disease” or a sexually transmitted disease.

“That’s where the stigma lies,” he said.

It spreads by direct skin contact and respiratory secretions during prolonged, face-to-face contact, or during intimate physical contact, according to the CDC. It can also spread by touching clothes and linens that came in contact with an infectious rash or body fluids.

“But it’s not a gay disease. Gay men are being unduly burdened by this disease and we’ve got to acknowledge that,” Halkitis said. “Let’s all pitch in so it doesn’t spread further. By helping gay men we’re helping ourselves.”…

Murphy was asked at a public event Wednesday if he would declare a public health emergency over monkeypox in New Jersey.

“I don’t know that we’re at the verge of a public health emergency, but everything’s on the table,” he told reporters in Camden.

Halkitis, meanwhile, predicted the disease won’t limit itself to only infecting gay and bisexual men within months if it isn’t stamped out.

“If we don’t stop it from spreading it will be in our population for the foreseeable future,” he said. “Do we want this thing to be another thing we live with for the rest of our lives?” (E)

“Health and Human Services Secretary Xavier Becerra said the federal government will announce allocations of the 786,000 vaccine doses to local authorities on Thursday.

The doses couldn’t be released until the Food and Drug Administration cleared them for use.

The FDA approved the two-dose Jynneos vaccine in 2019 for people ages 18 and older who are at high risk of exposure to monkeypox or smallpox.

Limited supply of the vaccine has led to long lines at clinics across the U.S.

The U.S. will make 786,000 additional monkeypox vaccine doses available to local health departments “as soon as possible” after the Food and Drug Administration approved the shots for distribution, the nation’s top health official said on Wednesday.” (F)

“Two months after the United States’ first monkeypox case was confirmed, the total has risen to about 2,900. But details about those cases and other epidemiological data aren’t spreading nearly as quickly as the virus itself, leaving holes in the response.

“It’s a new and really fast-moving outbreak, and I think there have been some challenges around having a smooth and efficient way for the data to be sent from jurisdictions” to the US Centers for Disease Control and Prevention, said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

The CDC only recently shared a first public look at monkeypox case demographics, which showed that the vast majority of cases have been among men who have sex with men, with a median age of 36.

But the agency has detailed information on only about half of the reported cases, CDC Director Dr. Rochelle Walensky said.

Monkeypox is now a reportable disease, which means public health departments work with local health care providers to collect information about people who are diagnosed and how they became ill. But it is still completely voluntary for states to share data on monkeypox with the CDC.

CNN reached out to the health departments of all 50 states; 29 responded, and they all said they are committed to sharing case data with the CDC. Some, however, said that they are collecting more information than they share.

As the US battles another public health challenge amid the ongoing Covid-19 pandemic, Walensky said she is “struck” by “how little authority we at CDC have to receive the data.”

“We very much want to get as much information and informed decisions out to the American public as possible. And yet again, like we were for Covid, we are again really challenged by the fact that we at the agency have no authority to receive those data. We’re working on that right now,” she said in a conversation with The Washington Post on Friday.

For example, Walensky said, the CDC has no data on who has been vaccinated for monkeypox and does not yet have the authority to collect that data.

The only data shared publicly on monkeypox vaccines is weekly updates from the US Department of Health and Human Services on how many doses have been distributed to each state…

Overall, the lack of data is hindering efforts to forecast the path the monkeypox outbreak might take.

“Right now we do not have enough detailed case data to develop robust estimates,” a CDC spokesperson said.

The CDC’s new Center for Forecasting and Outbreak Analytics, which formally launched this spring, “has been working to better understand the monkeypox outbreak,” including how to best optimize interventions such as vaccines.

“We anticipate that as the outbreak progresses we will be able to share forecasts,” the spokesperson said.

In the meantime, the vaccine supply is far from enough to meet demand — and covers just a fraction of the population that the CDC has recommended get it.

Walensky said she anticipates an increase in cases in the coming weeks, for three main reasons: a streamlined reporting form that makes it quicker and easier for states to report cases, a surge in testing as commercial laboratories have begun to offer tests, and recent exposures that will start to show symptoms.

“It is true that we have work to do — here and internationally — and are likely to see more monkeypox cases in the near term, but it is possible to significantly decrease the number of cases and contain the current monkeypox outbreak through education and increased testing and access to vaccines — all priorities we’ve made dramatic progress on,” the CDC said in a statement to CNN.” (G)

• A.U.S. may need $7 billion for monkeypox, Biden administration estimates, By Dan Diamond and Tony Room, https://www.washingtonpost.com/health/2022/07/26/monkeypox-aid-biden-administration-congress/
• B.Monkeypox: CDC says US leads globally in most known cases, By Bernd Debusmann Jr, https://www.bbc.com/news/world-us-canada-62308455
• C.More than 1,000 monkeypox cases confirmed in New York City, by Sam Levine, https://www.theguardian.com/us-news/2022/jul/26/more-than-1000-monkeypox-cases-confirmed-new-york-city
• D.As Monkeypox Spread in New York, 300,000 Vaccine Doses Sat in Denmark, By Joseph Goldstein and Sharon Otterman, https://www.nytimes.com/2022/07/25/nyregion/nyc-monkeypox-vaccine-doses-denmark.html?referringSource=articleShare
• E.N.J. makes ‘strong and urgent case’ for monkeypox vaccines as access remains limited, Murphy says, By Matt Arco, https://www.nj.com/politics/2022/07/nj-makes-strong-and-urgent-case-for-monkeypox-vaccines-as-access-remains-limited-murphy-says.html
• F.U.S. to release 786,000 additional monkeypox vaccine doses as outbreak spreads, by Spencer Kimball, https://www.cnbc.com/2022/07/27/us-to-release-786000-additional-monkeypox-vaccine-doses-as-outbreak-spreads.html
• G.Monkeypox is spreading faster than the data about it, hindering mitigation efforts, By Deidre McPhillips, https://www.cnn.com/2022/07/25/health/monkeypox-limited-data/index.html
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