US regulators clear way for more monkeypox vaccine shipments

This 2003 electron microscope image made available by the Centers for Disease Control and...
This 2003 electron microscope image made available by the Centers for Disease Control and Prevention shows mature, oval-shaped monkeypox virions, left, and spherical immature virions, right, obtained from a sample of human skin associated with the 2003 prairie dog outbreak. The World Health Organization will convene an emergency committee of experts to determine if the expanding monkeypox outbreak that has mysteriously spread outside its usual zones should be considered an international public health emergency.(Cynthia S. Goldsmith, Russell Regner/CDC via AP, file)
Published: Jul. 14, 2022 at 10:56 AM EDT
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WASHINGTON (AP) — Thousands more doses of monkeypox vaccine are expected to soon begin shipping to the U.S. after federal health officials said they had completed an inspection of the overseas plant where they were manufactured.

The update from the Food and Drug Administration comes amid soaring demand for the two-dose vaccine as thousands of people in New York City, California and other parts of the U.S. await a chance to get the shot.

On Wednesday, the Marion County Public Health Department reported the first two probable cases of the disease there. WPTA affiliate WTHR reported that the first probable case of monkeypox in Indiana was identified in mid-June. They say a total of 10 monkeypox cases have been confirmed in Indiana, not counting these two cases since they are still considered probable cases at this time.

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

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

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

Bavarian Nordic has already shipped 300,000 vaccine doses that were made at a third-party facility that had previously been authorized by the FDA.

The FDA requires prior inspections of all vaccine plants to assure their safety, sterility and consistency of production. A company spokesman said Bavarian Nordic sped up its plans to undergo the inspection after monkeypox began spreading in Europe in May. Initially, the company planned to submit its paperwork to the FDA in August for an inspection later in the fall.

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

White House officials have promised more supplies, chiefly from the more than 1 million-dose Bavarian Nordic stockpile.

Last month, New York-based activists blasted the FDA in a letter to the White House for not moving more swiftly to inspect the company’s plant and begin shipping the vaccines to the U.S. The letter from the HIV non-profit, PrEP4All, noted that European regulators had signed off on the plant last year.

While the FDA relies on inspections by foreign regulators to review some facilities, the FDA conducts its own inspections for vaccines “to ensure consistency in the inspection process,” the FDA spokeswoman noted.


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