HomeTechnologyUS Regulators Clear Way for More Monkeypox Vaccine Shipments

US Regulators Clear Way for More Monkeypox Vaccine Shipments


By MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — Thousands more doses of monkeypox vaccine are expected to begin shipping to the United States soon after federal health officials said they had completed an inspection of the overseas plant where it was made.

The update from the Food and Drug Administration comes amid growing demand for the two-dose vaccine, as thousands of people in New York City, California and other parts of the US await the opportunity to get vaccinated

More than 1.1 million doses of the vaccine purchased by the US government are currently at the Bavarian Nordic facility in Denmark. The company said earlier this week that it needed clearance from an FDA on-site inspection before it could ship them to the US.

An FDA spokeswoman said late Wednesday that regulators had “expedited and completed an inspection of the company’s plant.”

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“We do not expect any delay in vaccine availability due to this process,” he said in an emailed statement.

Bavarian Nordic has already shipped 300,000 doses of vaccines that were manufactured in a third-party facility that had been previously authorized by the FDA.

The FDA requires prior inspections of all vaccine plants to ensure their safety, sterility, and consistency in production. A company spokesman said Bavarian Nordic accelerated its plans to undergo inspection after monkeypox began to spread in Europe in May. The company initially planned to submit its documentation to the FDA in August for inspection later in the fall.

Bavarian Nordic’s two-dose Jynneos is one of two vaccines that can be given in the US to prevent monkeypox. The government has many more doses of an older smallpox vaccine, ACAM2000, that can also be used, but is considered to have a higher risk of side effects and is not recommended for people who have HIV. So it is the Jynneos vaccine that officials have been using as the main weapon against the outbreak.

Most monkeypox patients only experience fever, body aches, chills, and fatigue. People with more severe illnesses may develop rashes and lesions on the face and hands that can spread to other parts of the body.

Most of the roughly 1,000 reported cases in the US have been among men who have sex with men, but health officials stress that anyone can get the disease. The current number of reported cases in the US is likely an undercount because testing is still ramping up.

White House officials promised more supplies, mainly from more than 1 million doses of Bavarian Nordic stockpiles. The United States has ordered another 2.5 million doses for delivery later this year or early next.

Last month, New York-based activists criticized the FDA for not moving more quickly to inspect the company’s plant and begin shipping the vaccines to the US. In a letter to the White House, the organization without non-profit dedicated to HIV, PrEP4All, noted that those at the plant last year.

While the FDA relies on inspections by foreign regulators to review some facilities, the FDA said it conducts its own vaccine inspections “to ensure consistency in the inspection process.”

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Copyright 2022 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.



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