Mitigating a deficit that has plagued the fight against monkeypox for weeks, the Food and Drug Administration announcement Wednesday that he had authorized nearly 800,000 additional doses of vaccine for use. The Biden administration said it would announce allocations for states and jurisdictions on Thursday.
The new doses are expected to significantly increase supply in the United States, but some experts have questioned whether they will be enough to meet demand. Since May, the country has confirmed 3,600 cases, among the highest tallies in the world, and the figure is almost certainly an underestimate.
Supplies 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, the strategic national stockpile contained only a few thousand doses when the outbreak began, and the Biden administration has moved slowly by acquiring more.
US authorities have now ordered nearly seven million doses, which will arrive in batches over the next few months. So far, the administration has shipped about 320,000 doses to states.
The FDA said Wednesday it completed an inspection of Bavarian Nordic’s manufacturing plant in Denmark earlier this month and determined the vaccine produced there met its standards.
Given the growing needs, the agency said it had “facilitated the shipment of manufactured dosesin the United States, but declined to say whether the doses had arrived in the country.
“Aggressively responding to the monkeypox outbreak is a key priority,” said Xavier Becerra, secretary of the Department of Health and Human Services, said in a press release.
“HHS is working to make 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 alleviate at least some of the shortages. The supply is now “probably enough to meet the most pressing needs,” said Tinglong Dai, a vaccine supply expert at Johns Hopkins University.
What to know about the Monkeypox virus
What is monkey pox? 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 mainly been found in parts of West and Central Africa, but in recent weeks it has spread to dozens of countries and infected tens of thousands of people, overwhelmingly men with sex with men. July 23, the World Health Organization has declared monkeypox a global health emergency.
“I hope this will ease the searing anxiety that thousands of people have felt over the past few weeks,” he added.
The Bavarian Nordic has less than five million doses in hand, in addition to the two million it will supply to the United States by the end of the year. A manufacturing facility that could do more was close for an expansion planned since last August.
But more vaccine doses will be needed as several cities have expanded their monkeypox vaccination criteria to include sex workers, sexual health clinic patients, clinicians and other staff. likely to be exposed to the virus at work.
Men who have sex with men account for 99% of cases so far. The United States has identified 13 infected women, 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, the number of people lining up for the vaccine may also increase. “I’m afraid it’s too little” to meet that demand, Dr Dai said of the new supply.
The activists said that the FDA did not act 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 denied those charges.
“There were no delays in the inspection of the Nordic Bavarian factory,” said Abigail Capobianco, spokeswoman for the FDA.
But James Krellenstein, co-founder and chief executive of advocacy group PrEP4All, noted that the European Medicines Agency inspected and approved the facility last year.
“We missed months when these doses could have been used to slow or stem this outbreak,” he said. “There was no scientific or medical justification for doing so.”
Jynneos is meant to be given as two doses given 28 days apart. Working to protect residents with few suppliescertain jurisdictions – including Colorado, San Francisco, washington dc, and New York City — decided to delay second doses until supply opened, a strategy also employed in Britain and Canada.
Studies by Bavarian Nordic suggest that a single injection of Jynneos produces an immune response comparable to that of the earlier smallpox vaccine and should be protective, although immunity appears to begin to decline after two years.
“Some people may not be fully protected, but overall the strategy makes sense when supply is limited,” Dr. Dai said. Britain also postponed second doses of Covid vaccines at the start of the pandemic, when stocks were low, and offered them once new 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 with a supply of Jynneos. An older vaccine developed to fight smallpox is available worldwide but too dangerous for people who are immunocompromised or have certain skin conditions.
The United States has purchased bulk material from Jynneos that can be converted into some 15 million finished doses over the next few weeks or months. The administration should share some of that supply with the rest of the world, said Zain Rizvi, who studies access to medicine at Public Citizen, an advocacy group.
“A global epidemic requires a global response,” said Mr. Rizvi. “The Biden administration should urgently convert its bulk stockpile into vaccines and live up to its claim to be a vaccine arsenal for the world.”