Relieving shortages that have plagued the monkeypox fight for weeks, the Food and Drug Administration announced Wednesday that it has authorized nearly 800,000 additional doses of the vaccine. The Biden administration said it would announce state and jurisdictional allocations on Thursday.
The new doses should greatly expand supply in the United States, but some experts question whether they will be enough to meet demand. Since May, the country has confirmed 3,600 cases, among the highest in the world, and the figure is almost certainly an underestimate.
Stores of Jynneos, the monkeypox vaccine, have been limited since the outbreak began. The vaccine is produced by Bavarian Nordic, a small company in Denmark.
Although federal agencies helped develop Jynneos, the strategic national stockpile contained only a few thousand doses when the outbreak began, and the Biden administration has moved slowly in acquiring more.
US officials have already ordered nearly seven million doses, which will arrive in batches over the coming months. So far, the administration has sent about 320,000 doses to the states.
The FDA said Wednesday that it completed an inspection of Bavarian Nordic’s manufacturing plant in Denmark earlier this month and found that the vaccine produced there met its standards.
Given the growing need, the agency said it had “facilitated the shipment of manufactured doses” to the United States, but declined to say whether the doses had arrived in the country.
“An aggressive response to the monkeypox outbreak is a critical priority,” Xavier Becerra, secretary of the Department of Health and Human Services, said in a statement.
“HHS is working to provide these doses to states and jurisdictions as soon as possible to meet their needs, and will announce the allocations tomorrow,” he added.
Assuming the doses are distributed quickly, they should alleviate at least some of the shortage. The supply now “is probably sufficient to meet the most urgent needs,” said Tinglong Dai, an expert on vaccine supply at Johns Hopkins University.
What you need to know about the monkeypox virus
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What is monkeypox? Monkeypox is a virus similar to smallpox, but the symptoms are milder. It was discovered in 1958 after an outbreak in monkeys kept for research. The virus was found mostly in parts of central and west 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 emergency.
I’m afraid I might have monkey pox. What should I do? There is no way to get tested 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 can order a monkeypox test. Isolate at home as soon as you develop symptoms and wear high-quality masks if you need to come into contact with others for medical care.
What is the treatment for monkeypox? If you do get sick, treating monkeypox usually involves controlling the symptoms. Tecovirimat, an antiviral drug also known as TPOXX, can sometimes be used in severe cases. The Jynneos vaccine, which protects against variola 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 monkeypox infections. Jynneos is the most commonly used and consists of two doses given every four weeks. Because supply is limited, it is primarily offered to healthcare workers and people who have had confirmed or suspected exposure to monkeypox. Several states, including New York, have also made vaccines available to higher-risk populations, including men who have sex with men.
“I hope it eases the burning anxiety that thousands of people have felt in recent weeks,” he added.
Bavarian Nordic has less than five million doses on hand, in addition to the two million it is shipping to the United States by the end of the year. A production facility that could have produced more has been closed for a planned expansion since last August.
But more doses of the vaccine will be needed because several cities have expanded their monkeypox immunization criteria to include sex workers, sexual health clinic patients, clinicians and other staff members who may be exposed to the virus during on work.
Men who have sex with men are 99% of the time so far. The United States has identified 13 women who were infected, including a pregnant woman who has since given birth to a healthy baby, and two young children.
But as awareness and access to testing grows, the number of people queuing up for the vaccine may also grow. “I’m afraid it’s too small” to meet that demand, Dr. Dye said of the new supply.
Activists said the FDA failed to move quickly to inspect manufacturing facilities in Denmark and that it was not doing enough to explore other manufacturing options in the United States.
The agency has denied these allegations.
“There was no delay in the inspection of the Bavarian Scandinavian plant,” FDA spokeswoman Abigail Capobianco said.
But James Krellenstein, co-founder and managing director of the advocacy group PrEP4All, noted that the European Medicines Agency inspected and approved the facility last year.
“We missed months of time where these doses could have been used to slow or stop this outbreak,” he said. “There was no scientific or medical justification for it.”
Jynneos is supposed to be administered in two doses delivered every 28 days. Working to protect residents with scarce supplies, some jurisdictions — including Colorado, San Francisco, Washington, D.C. and New York — have decided to delay second doses until supplies begin, a strategy also used in Britain and Canada.
Bavarian Nordic’s studies suggest that a single injection of Jynneos elicits an immune response comparable to that of the earlier smallpox vaccine and should be protected, although immunity appears to begin to wane after two years.
“Some people may not be fully protected, but overall the strategy makes sense when supplies are limited,” Dr Dye said. Britain also delayed second doses of Covid vaccines early in the pandemic, when supplies were low, and offered them after more doses became available, he noted.
So far, the FDA and the Centers for Disease Control and Prevention have been pushing for a two-dose regimen. “While the agency understands the desire to extract as many doses as possible, the FDA advises against deviating from product labeling,” Ms. Capobianco said.
The United States is among the few countries that have Jynneos shipping. An older vaccine developed to fight smallpox is available worldwide, but is too dangerous for people with weakened immune systems or certain skin conditions.
The United States has purchased bulk material from Jynneos that could be turned into about 15 million finished doses in the next few weeks to months. The administration should share some of that supply with the rest of the world, said Zain Rizvi, who studies access to medicines at Public Citizen, an advocacy group.
“A global epidemic requires a global response,” Mr Rizvi said. “The Biden administration must urgently convert its large vaccine stockpile and live up to its claim to be the world’s vaccine arsenal.”
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