U.S. health regulators on Wednesday confirmed that 800,000 doses of the much-needed monkeypox vaccine will soon be available for distribution.
The announcement comes nearly two weeks after the Food and Drug Administration said it had finished the necessary inspections at Bavarian Nordic's facility in Denmark, where the company fills vials of the vaccine.
FILE - A health care worker prepares a monkeypox vaccine in Montreal, July 23, 2022. (Graham Hughes/The Canadian Press via AP, File)
"Given the emerging public health need, FDA previously facilitated the shipment of manufactured doses to the U.S. so they would be ready to be distributed once the manufacturing changes were approved," the FDA said on Twitter after confirming that the certification had been finalized.
The United States has already sent more than 310,000 doses of the two-shot Jynneos vaccine to state and local health departments. But clinics in San Francisco, New York and other major cities say they still don't have enough shots to meet demand.
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The head of the U.S. Department of Health and Human Services said Wednesday that officials would announce more allocations on Thursday.
The monkeypox virus mainly spreads through skin-on-skin contact, but it can also transmit through touching linens used by someone with the infection. The vast majority of cases reported have been in men who have sex with men.
People wait to receive the monkeypox vaccine at a mass vaccination site in Manhattan, July 26, 2022, in New York City. (Photo by Liao Pan/China News Service via Getty Images)
People with monkeypox might experience fever, body aches, chills and fatigue. Many people have developed zit-like bumps on their body.
The doses previously shipped came from a separate facility in Denmark that already had FDA clearance. Another 786,000 doses made at a newly opened Bavarian Nordic facility were awaiting the U.S. certification announced Wednesday.
The FDA requires inspections of all vaccine manufacturing plants to assure safety, sterility and consistency of production.
U.S. officials announced orders this month for 5 million more doses, though most of those are not expected to arrive until next year.
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Officials have recommended that the shots be given to people who know or suspect they were exposed to monkeypox in the previous two weeks.
The Associated Press contributed to this report.