On the Thursday before Pride Weekend last month, hundreds of men dropped what they were doing and ran to a city 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 spreading quickly
But there was a problem: there were only 1,000 doses available. Within two hours, the only clinic offering vaccinations began turning people away.
At the same time, about 300,000 doses of a ready-to-use vaccine owned by the United States were sitting in a facility in Denmark. US officials had waited weeks as the virus spread to New York and beyond before deciding to send those doses to the United States.
Even then, there was little apparent urgency: the doses were blown up gradually, arriving over the course of two weeks. Many did not arrive until July, more than six weeks after the first case was identified in New York City.
By curbing the doses, an early opportunity to contain or slow the nation’s largest smallpox outbreak appears to have been passed. On Saturday, the World Health Organization declared monkeypox a global health emergency. At least 16,000 cases have been reported worldwide, with about 3,000 in the United States. Infections in New York City account for nearly a third of the number of national cases.
Limited testing means these numbers are likely a significant undercount.
The federal response to monkeypox, including limited testing capacity, echoes how public health authorities initially mishandled Covid-19.
With monkeypox, however, the federal government had a powerful tool to stop the spread early: an effective vaccine.
However, the government was slow to roll out the vaccine, which was originally developed and stockpiled for use against smallpox, campaigners say.
“The US government intentionally deprioritized the health of gay men in the midst of an out-of-control outbreak due to a potential bioterrorism threat that does not currently exist,” said James Krellenstein, a Brooklyn-based gay health activist. who has been urging health officials to make the vaccine more widely available since June.
The federal official in charge of the agency that manages the US supply, Gary Disbrow, said the government “is moving very quickly because we take this very seriously.”
“We thought it prudent to get as many doses as we had available here, fully understanding that if the doses were not used there would be a potential impact on smallpox,” he added. “We moved very quickly based on the number of cases we saw.”
Called Jynneos, the vaccine is effective against both smallpox, which generally has a 30 percent fatality rate, and monkeypox, which can be serious but has a much lower fatality rate.
When monkeypox was first detected in the United States in mid-May, there were about 2,400 doses on American soil, in the federal government’s strategic national stockpile, used primarily to protect laboratory workers and the Centers for Disease Control and Prevention staff who were involved in the investigation, officials said. said
What you need to know about monkeypox virus
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What is monkey pox? Monkey pox is a virus similar to smallpox, but the symptoms are less severe. It was discovered in 1958, after outbreaks occurred in monkeys kept for research. The virus was found primarily in parts of central and western Africa, but in recent weeks it has spread to dozens of countries and infected tens of thousands of people, mostly men who have sex with men. On July 23, the World Health Organization declared monkeypox a global health emergency.
I’m afraid I might have monkey pox. What should I do? There is no way to test for monkeypox if you only have flu-like symptoms. But if you start to notice red lesions, you should contact an urgent care center or your primary care doctor, who may order a chickenpox test. Isolate at home as soon as you develop symptoms and wear high-quality masks if you must come into contact with others for medical care.
What is the treatment for monkey pox? If you do get sick, treating monkeypox usually involves managing your symptoms. Tecovirimat, an antiviral drug also known as TPOXX, may be used occasionally for severe cases. Jynneos vaccine, which protects against smallpox and monkeypox, can also help reduce symptoms, even if taken after exposure.
Can I get the vaccine? Two vaccines originally developed for smallpox can help prevent smallpox infections. Jynneos is the most commonly used, and consists of two doses administered four weeks apart. Because supply is limited, it has been offered primarily to healthcare workers and people who have had confirmed or suspected exposure to smallpox. Some states, including New York, have also made vaccines available to high-risk populations, including men who have sex with men.
The United States also possessed more than a million doses of Jynneos in ready-to-use vials, and enough vaccine for millions more that had yet to be filled into vials, in Denmark, where it is headquartered the producer of the vaccine, Bavarian Nordic.
Much of that supply was tied up in 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, a problem that has not yet has been completely resolved.
But there were 372,000 US-owned doses 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 FDA approval.
However, instead of quickly transferring these doses to the United States and beginning to administer them, the federal government took 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.
The task of managing the nation’s supply of Jynneos falls largely to the Biomedical Advanced Research and Development Authority, or BARDA, a federal agency that develops and purchases drugs and vaccines to protect against pandemics, bioterrorism and other dangers. The authority supported the development of the vaccine after the terrorist attacks of September 11, 2001, as the federal government was concerned about the use of weaponized smallpox.
One of the reasons 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 were not as cold as the facilities in Denmark, said Dr. Disbrow, a senior Department of Health and Human Services official who heads BARDA.
“So if all the doses weren’t needed for the outbreak,” he said, “their lifespan would be dramatically shortened.”
Joseph Osmundson, a microbiologist and queer activist, said the smallpox outbreak may not have been the emergency the federal government had been preparing for, weaponized smallpox, “but this is an emergency nonetheless.”
“There is no excuse for this level of bureaucratic inaction,” he said.
The first case of monkeypox 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 asked Bavarian Nordic to send more than 36,000 doses, an agency spokeswoman said. They arrived five days later.
On May 27, BARDA ordered 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 only so many doses could be carried per flight. In an email, a spokesman for Bavarian Nordic explained that each large order required a lead time. The company had to first receive a container, known as a cocoon, from the shippers and then “freeze them at room temperature for five days” before packing it with the vaccine.
As of June 10, the federal government had distributed only a few thousand doses of monkeypox vaccine to states, officials said on a call with reporters earlier today. A senior Health and Human Services official, Dawn O’Connell, said the United States would receive 300,000 doses of Jynneos “in the coming weeks.”
Except, the US government hadn’t asked them yet. “This order came at the end of June,” said a Nordic Bavarian spokesman.
Dr. Disbrow, the director of BARDA, gave a similar timeline in an interview, although an agency spokeswoman later said the government ordered those doses earlier, on June 14.
By all accounts, the first shipments of the remaining 300,000 doses did not begin arriving until June 29 or 30, several days after the New York Pride March and related festivities, and they arrived in several shipments , said Dr. Disbrow.
But many of the doses did not arrive until July. Bavarian Nordic said some were delayed in part because they had to be flown from Copenhagen to Germany, because airline pilots were on strike at SAS, the Scandinavian airline.
Asked about the delays, BARDA spokeswoman Elleen Kane said if only “working days” were counted the delay was shorter.
Mr. Krellenstein, the activist who leads a group, PrEP4ALL, which works to increase access to daily medication that prevents HIV infection, was one of the first to get vaccinated during the first window in New York City, on June 23. But he received a deluge. of text messages from friends who said they were lost.
That evening, Mr. Krellenstein called a health activist he knew in Boston: “We said, ‘Oh my God, the doses aren’t coming.’ What is happening?'”
He said he was surprised to learn that most of the doses were stuck in Denmark pending inspection of the FDA facility.
Along with several HIV/AIDS activists, including some from the ACT UP group, Mr. Krellenstein began demanding meetings with the White House and federal health officials to learn more about…