US distributes 800,000 monkeypox vaccines

Alleviating the shortage that has plagued the fight against monkeypox for weeks, the Food and Drug Administration publication That on Wednesday it cleared nearly 800,000 additional doses of vaccine for use. The Biden administration said Thursday it would announce allocations to states and jurisdictions.

The new doses should significantly expand supply in the United States, but some experts wondered if they were sufficient to meet the demand. Since May, the country has identified 3,600 cases in the highest aggregate in the world, which is arguably underestimated.

Shops for the monkeypox vaccine Jynneos have been restricted since the outbreak began. The vaccine is made by a small Danish company, Bavarian Nordic.

Federal agencies supported the development of Jynneos, but strategic national stockpiles held doses of only a few thousand times when the outbreak began, and the Biden administration Moved slowly By getting more.

US officials are currently ordering nearly 7 million doses, which will arrive in batches in the coming months. So far, the government has shipped about 320,000 batches to the state.

The FDA said Wednesday that it completed inspections of its Bavarian Nordic manufacturing plant in Denmark earlier this month and determined that the vaccines produced there met the criteria.

In light of growing needs, the agency said:Facilitated shipping of manufactured dosesWas sent to the United States, but did not disclose whether the dose had arrived in the country.

“Actively responding to monkeypox outbreaks is an important priority,” said Xavier Becerra, Secretary-General 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 soon as possible to meet their needs and will announce quotas tomorrow,” he added.

Assuming the doses are distributed quickly, they should alleviate at least some deficiencies. Vaccine supply expert at Johns Hopkins University, Tinglong Dai, said the current supply is “probably sufficient to meet the most pressing needs.”

“We hope that the burning anxiety experienced by thousands of people in the last few weeks will be alleviated,” he added.

Bavarian Nordic Less than 5 million doses In addition to 2 million units, we will supply them to the United States by the end of the year.There are manufacturing facilities that can make more shut Expansion plan from August last year.

However, more because some cities have expanded the standard of immunity to monkeypox, including sexual workers, patients in sexual health clinics, clinicians, and other staff who may be exposed to the virus at work. Many vaccines will be required.

So far, 99% of men have sex with men. The United States has identified 13 infected women. 1 pregnant woman Since then, he has given birth to a healthy baby and two young children.

However, as awareness and access to testing increases, so does the number of people on the vaccine line. “I’m worried that it’s too little,” Dr. Dai said to meet that demand.

The activist said The FDA was unable to act swiftly to inspect the Danish manufacturing facility and did not do enough to investigate other manufacturing options in the United States.

The agency denied those accusations.

“There was no delay in inspecting the Bavarian Nordic plant,” said Abigail Capobianco, an FDA spokeswoman.

However, James Krellenstein, co-founder and managing director of the advocacy group PrEP4All, said the European Medicines Agency inspected and approved the facility last year.

“We missed a few months that these doses could have been used to delay or stop this outbreak,” he said. “There was no scientific or medical justification for doing so.”

Jynneos is to be given twice every 28 days.Efforts to protect the inhabitants Scarce suppliesSome jurisdictions — including Colorado, San Francisco, Washington DC, When New York City — We have decided to postpone the second dose until the supply is started. This strategy United Kingdom And Canada.

the study Bavarian Nordic suggests that a single shot of Jynneos produces an immune response Similar Immunity seems to begin to decline after two years, but it should be the same and defensive as that of previous smallpox vaccines.

“Some people may not be fully protected, but when balanced, the strategy makes sense when supply is limited,” said Dr. Dai. He said the UK also postponed a second dose of the Covid vaccine in the early stages of the pandemic when supply was low and provided them when another dose was available.

So far, the FDA and the Centers for Disease Control and Prevention have claimed a double-dose regimen. “The authorities understand the desire to take as many doses as possible, but the FDA advises not to deviate from the product label,” Capobianco said.

The United States is one of the few countries supplying Jynneos. Old vaccines developed to combat smallpox are available worldwide, but are too dangerous for people with immunodeficiency and certain skin conditions.

The United States has purchased Jynneos bulk material that can be converted to a final dose of approximately 15 million doses in the coming weeks and months. Zain Lizbi, an advocacy group studying access to medicines at Public Citizen, said the government needed to share some of its supply with other parts of the world.

“A global outbreak requires a global response,” Lizbi said. “The Biden administration must urgently convert its large stockpile into vaccines and respond to his claim that it is the weapon of vaccines in the world.”