FDA approves nearly 800,000 monkeypox vaccine doses

Monkeypox Vaccine
New York City and New York State have declared emergencies due to the monkeypox outbreak.
Graham Hughes/The Canadian Press via AP, File

The Food and Drug Administration (FDA) has authorized the distribution of nearly 800,000 doses of the JYNNEOS monkeypox vaccine, paving the way for a much-needed increase in supply at a time when the monkeypox outbreak has fueled significant demand for jabs among men who have sex with men.

In a series of tweets posted on July 27, the FDA announced the approval of “a supplement to the biologics” for the JYNNEOS vaccine after completing an inspection of a plant earlier this month and finishing a subsequent evaluation of product quality.

The influx of doses comes after news reports indicated that hundreds of thousands of doses from Denmark were held up by inspection and regulatory hurdles. According to the FDA, additional doses have already arrived after getting shipped to the United States.

“With this supplement approval, those manufactured doses may now be further distributed and administered,” the FDA tweeted. “Additional doses manufactured at this plant can help address the need for this vaccine moving forward.

Monkeypox cases have continued to spread across the globe and within the United States. As of July 27, the CDC registered 4,639 monkeypox cases across the country — and the New York City Department of Health and Mental Hygiene has tallied 1,148 total cases alone as of July 27.

“This action by the FDA is a critical step forward in our plans to strengthen and accelerate our monkeypox response, which includes distributing a safe and effective vaccine to those at highest risk of exposure to monkeypox,” US Health and Human Services Secretary Xavier Becerra said in a written statement. “The expedited inspection and approval by FDA of Bavarian Nordic’s fill-and-finish capabilities means that an additional 786,000 doses of vaccine are now available for use in the U.S.”

The World Health Organization declared monkeypox a global emergency on July 23 and out gay Congressmember Ritchie Torres of the Bronx led a resolution on July 26 calling on HHS to declare a public health emergency in the United States due to monkeypox. Twenty-two additional members of Congress co-sponsored the resolution, including out gay lawmakers Mondaire Jones of New York, Mark Takano of California, and Mark Pocan of Wisconsin.

Those eligible for the monkeypox vaccine in New York City include men who have sex with men and transgender, gender non-conforming, and non-binary individuals who are at least 18 years of age and have had multiple or anonymous sex partners in the last two weeks. The Health Department also recommends vaccination for anyone who has been a close contact of someone with monkeypox.

The vaccine shortage has prompted some cities — including New York, San Francisco, and now Washington, DC — to focus, for now, on providing first doses of the two-dose Jynneos regimen, which is typically administered 28 days apart.

Monkeypox has been primarily spreading among men who have sex with men. As of July 19, men accounted for 97.7% of monkeypox cases in New York City, while transgender, gender non-conforming, and non-binary folks represented 1.4% of cases. Just one woman tested positive for monkeypox.

Those between 30 and 39 years of age made up the largest share of cases, with 50%. More than half of the New York City-based cases (54%) came out of Manhattan, followed by Brooklyn (21.6%). Queens (12.4%), the Bronx (11.4%), and Staten Island (0.5%). White people led the way with 31% of cases, while Hispanic/Latino folks made up 21.4% of cases and Black/African-American folks represented 17.2%. Just 3.4% of cases were among Asian/Pacific Islander individuals and 26.6% were unknown.

There will be further announcements on July 28 regarding the allocation of vaccine doses around the country, Becerra added.

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