Alleviating a deficit that has plagued the fight against monkeypox for weeks, the Food and Drug Administration announced on Wednesday that it had released nearly 800,000 additional vaccine doses for use. The Biden administration said it will announce state and jurisdiction allocations on Thursday.
The new cans were intended to greatly expand supply in the United States, but some experts questioned whether they would be enough to meet demand. Since May, the country has confirmed 3,600 cases, one of the highest tally in the world, and the number is almost certainly an underestimate.
Stocks of Jynneos, the monkeypox vaccine, have been limited since the outbreak began. The vaccine is made by Bavarian Nordic, a small company in Denmark.
Although federal agencies helped develop Jynneos, when the outbreak began, the strategic national stockpile contained only a few thousand doses, and the Biden administration has slowly scrambled to acquire more.
American officials have now ordered nearly seven million doses, which will arrive in batches over the next few months. So far, the government has shipped about 320,000 doses to states.
The FDA said on Wednesday that earlier this month it completed an inspection of Bavarian Nordic’s manufacturing facility in Denmark and found the vaccine manufactured there met its standards.
With the need increasing, the agency said it has “facilitated the shipping of manufactured cans‘ to the United States, but declined to say whether the cans had arrived in the country.
“An aggressive response to the monkeypox outbreak is a top priority,” Xavier Becerra, secretary of the Department of Health and Human Services, said in a statement.
“HHS is working to get these doses available 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 at least alleviate some of the bottlenecks. The supply now is “probably sufficient to meet most urgent needs,” said Tinglong Dai, a vaccine supply expert at Johns Hopkins University.
What you should know about Monkeypox virus
What is monkeypox? Monkeypox 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 has been 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 health emergency.
“I hope it eases the searing anxiety that thousands of people have been experiencing over the past few weeks,” he added.
Bavarian Nordic has fewer than five million cans on hand, on top of the two million it will ship to the United States by the end of the year. A manufacturing facility that could do better has been closed since last August for a planned expansion.
More vaccine doses are needed, however, as several cities have broadened their criteria for monkeypox vaccination to include sex workers, sexual health clinic patients, clinicians and other staff who may be exposed to the virus at work.
Men who have sex with men make up 99 percent of cases 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 increases, so may the number of people lining up for the vaccine. “I’m afraid it’s too little” to meet that demand, said Dr. Dai about the new offer.
Activists said the FDA has failed to inspect manufacturing facilities in Denmark quickly and is not doing enough to explore other manufacturing opportunities in the United States.
The agency denied these allegations.
“There was no delay in inspecting the Bavarian Nordic plant,” said Abigail Capobianco, a spokeswoman for the FDA
However, James Krellenstein, co-founder and chief executive of the PrEP4All advocacy group, noted that the European Medicines Agency had inspected and approved the facility for the past year.
“We missed months of time when these doses could have been used to slow or contain this outbreak,” he said. “There was no scientific or medical justification for this.”
Jynneos is to be given in two doses 28 days apart. To protect residents with tight supplies, some jurisdictions — including Colorado, San Francisco, Washington, DC and New York City — have decided to delay the second dose until supplies open, a strategy also used in the UK and Canada becomes.
Studies by Bavarian Nordic suggest that a single injection of Jynneos elicits an immune response comparable to that of the earlier smallpox vaccine and should be protective, although immunity appears to wane after two years.
“Some people may not be fully protected, but overall the strategy makes sense when care is limited,” said Dr. dai Britain also postponed second doses of the Covid vaccines early in the pandemic when supplies were low and offered them as more doses became available, he noted.
So far, the FDA and the Centers for Disease Control and Prevention insist on a two-dose regimen. “While the agency understands the desire to release 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 a supply of Jynneos. An older vaccine designed to fight smallpox is available worldwide but is too dangerous for people with compromised immune systems or certain skin conditions.
The United States has purchased bulk material from Jynneos that can be converted into about 15 million finished doses over 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 outbreak requires a global response,” Mr Rizvi said. “The Biden administration should urgently convert its bulk stockpile into vaccines and live up to its claim to be an arsenal of vaccines for the world.”