USA distributes 800,000 doses of monkeypox vaccine

The Food and Drug Administration has been working for weeks to ease the monkeypox fight shortage. announced on Wednesday it cleared 800,000 additional doses of the vaccine for use. The Biden administration said Thursday it will release the allocations for states and jurisdictions.

The new doses should greatly expand supply in the United States, but some experts doubted whether they would be enough to meet demand. Since May, the country has confirmed 3,600 cases, one of the highest in the world, and the figure is hardly underestimated.

Ginneos, the monkeypox vaccine, has had limited availability since the outbreak began. The vaccine is made by a small company called Bavarian Nordic in Denmark.

Although the federal government helped develop Ginneos, the strategic national stockpile held only a few thousand doses when the outbreak began, and the Biden administration has been slow to get more agencies involved.

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

The FDA said on Wednesday that it completed an inspection of the Bavarian Nordic manufacturing facility in Denmark earlier this month and found that the vaccine produced there meets its standards.

Considering the growing need, the agency said:made it easier to send manufactured doses” sent to the United States, but refused to say whether the doses had arrived in the country.

“An aggressive response to monkeypox is an important priority,” Health and Human Services Secretary Xavier Becerra said in a statement.

“HHS is working to get these doses to states and jurisdictions as quickly as possible and will announce distributions tomorrow to meet their needs,” he added.

Assuming the doses are distributed rapidly, they should reduce at least some of the deficiency. Tinglong Dai, an expert on vaccine supplies at Johns Hopkins University, said the supply now is “sufficient to meet the most acute need.”

“I hope this eases the anxiety thousands of people have experienced in recent weeks,” he added.

Bavarian Nordic has just under five million doses on hand, with two million to be delivered to the United States by the end of the year. The manufacturing facility, which would have been overcrowded, has been closed since last August for a planned expansion.

But more doses of the vaccine are needed because several cities have expanded the criteria for rabies vaccination to include sex workers, patients at sexual health clinics, clinics and other workers who may be exposed to the virus on the job.

99 percent of men who have had sex with men before. The United States has identified 13 infected women, including a pregnant woman who gave birth to a healthy baby and two young children.

But as awareness and access to testing increases, so will the number of people on the vaccine waiting list. “I’m afraid it’s too little to satisfy this demand,” said Dr. Dai said about the new equipment.

Activists say the FDA has not moved quickly enough to inspect manufacturing facilities in Denmark, and it is not doing enough to explore other manufacturing options in the United States.

The agency denied the allegations.

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

But James Krellenstein, co-founder and managing director 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 stop the outbreak,” he said. “There was no scientific or medical basis for doing so.”

Jynneos should be given in two doses delivered 28 days apart. In an effort to protect low-income residents, some jurisdictions, including Colorado, San Francisco, Washington, D.C., and New York, have decided to delay the second dose until delivery opens, a strategy also used in Britain and Canada.

Research by Bavarian Nordic suggests that a single shot of Jyneos produces an immune response comparable to earlier smallpox vaccines and that immunity appears to wane after two years, but should be protective.

“Some people may not be completely protected, but when the balance is limited, the strategy makes sense,” said Dr. Say it. Britain also delayed the second dose of Covid vaccines at the start of the pandemic, when they were in short supply and offered them after more doses became available, he noted.

For now, the FDA and the Centers for Disease Control and Prevention are recommending a two-dose regimen. “While the agency understands the desire to get as many doses as possible, the FDA advises against labeling the product,” Ms. Capobianco said.

The United States is among the few countries that supply Jynneos. An older vaccine designed 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 converted into about 15 million ready-made doses over the next few weeks to months. The administration needs to share some of that supply with the rest of the world, said Zain Rizvi, who studies drug access at the advocacy group Public Citizen.

“A global epidemic requires a global response,” said G. said Rizvi. “The Biden administration must urgently transform its core stockpile of vaccines and fulfill its claim to have an arsenal of vaccines for the world.”

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