U.S. to Distribute 800,000 Doses of Monkeypox Vaccine

The Food and Drug Administration downplaying the shortage, which has affected the fight against monkeypox for weeks announced On Wednesday it approved about 800,000 additional doses of the vaccine for use. The Biden administration said it would announce allocations for states and jurisdictions on Thursday.

The new doses should 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, the most in the world, and the figure is almost certainly lower.

The stores of Genios, monkeypox vaccines, have been constrained since the start of the outbreak. The vaccine is made by a small Danish company, Bavarian Nordic.

Although federal agencies helped develop Genios, the strategic national stockpile contained only a few thousand doses when the outbreak began, and the Biden administration has gradually moved on to acquiring more.

US officials have now ordered about seven million doses, which will arrive in batches over the next months. The administration has so far sent about 320,000 doses to the states.

The FDA said on Wednesday that it had completed an inspection of Bavarian Nordic’s manufacturing plant in Denmark earlier this month and determined that the vaccine produced there met its standards.

In view of the growing need, the agency stated that it has “Facilitated shipment of manufactured supplements“For the United States, but declined to say whether the dose has arrived in the country.

“An aggressive response to the monkeypox outbreak is an important priority,” Javier Becerra, Secretary of the Department of Health and Human Services, said in a statement.

“HHS is working to make these doses available to states and jurisdictions as quickly as possible to meet their needs and will announce allocations tomorrow,” he said.

Assuming that doses are delivered quickly, they should at least reduce some of the drawbacks. Now supplies are “enough to meet the most pressing need”, said Tinglong Dai, a specialist in vaccine supply at Johns Hopkins University.

“I hope this will ease the worry of irritation being experienced by thousands of people in recent weeks,” he said.

Bavarian Nordic has less than five million doses on hand, in addition to the two million it is supplying to the United States by the end of the year. A manufacturing facility that could have produced more has been closed since last August for a planned expansion.

But more vaccine doses will be needed, as many cities have expanded their criteria for vaccination against monkeypox to include sex workers, patients at sexual health clinics, physicians and other staff members who have been exposed to the virus at work. can come in contact.

By far 99 percent of cases are in men who have sex with men. The United States has identified 13 women 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 a vaccine may also increase. “I’m afraid it’s too low” to meet that demand, Dr Dai said of the new supply.

Activists said the FDA failed to move quickly to inspect manufacturing facilities in Denmark and was not doing enough to explore other manufacturing options in the United States.

The agency has denied those allegations.

“There was no delay in the inspection of the Bavarian Nordic plant,” said Abigail Capobianco, a spokeswoman for the FDA.

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 in which these doses could have been used to slow or stop this outbreak,” he said. “There was no scientific or medical justification for doing so.”

Jynneos should be given in two doses spaced 28 days apart. To protect residents with short supplies, some jurisdictions, including Labor, Colorado, San Francisco, Washington, DC and New York City, have decided to postpone second doses until supplies open up, a strategy also employed in the UK and Canada.

Studies by the Bavarian Nordic show that a shot of Genios produces an immune response comparable to an earlier smallpox vaccine and should be protective, although immunity begins to decline after two years.

“Some people may not be fully protected, but on balance, the strategy makes sense when supplies are disrupted,” Dr Dai said. He said Britain also deferred second doses of COVID vaccines at the start of the pandemic, when supplies were short, and introduced them once more doses were available.

So far the FDA and the Centers for Disease Control and Prevention are pushing a two-dose regimen. “While the agency understands the desire to achieve greater doses, the FDA recommends a departure from product labeling,” said Capobianco.

The United States is one of the few countries to which Genios is supplied. An older vaccine developed to combat smallpox is available around the world, but is very dangerous for people who are immunocompromised or who have certain skin conditions.

The United States has purchased Jynneos’ bulk ingredients that could 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 drugs at Public Citizen, an advocacy group.

“A global outbreak demands a global response,” Mr Rizvi said. “The Biden administration must immediately convert its bulk stockpile into vaccines, and live up to its claim of having an arsenal of vaccines for the world.”