U.S. regulators clear way for more monkeypox vaccine shipments

Earlier this week, New York city’s system for scheduling vaccination appointments crashed due to online traffic.

The U.S. government has shipped 132,000 doses of the vaccine to health departments, including more than 21,000 to New York City and 44,000 to California. Federal officials are distributing the vaccines based on each area’s case numbers and the portion of the population that is at higher risk from the virus.

Most of the roughly 1,000 cases reported in the U.S. 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 is likely an undercount because testing is still ramping up. U.S. officials are partnering with several large commercial testing laboratories and say they expect to be able to process 70,000 tests per week by the end of the month.

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

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 Jynneos is one of two vaccines that can be given in the U.S. to prevent monkeypox. The government has many more doses of the other vaccine — an older smallpox vaccine called ACAM2000 that 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 using as a primary weapon against the outbreak.

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The Centers for Disease Control and Prevention recommends the vaccine for people who have already been exposed to the virus and their presumed contacts. That includes men who have recently had sex with men at parties or in other gatherings in cities where monkeypox cases have been identified.

The CDC estimates that about 1.5 million American men are eligible for the vaccine based on their HIV status and other risk factors.

Eventually health experts want to see a broader vaccination campaign to preemptively protect people at high risk.

“There is not enough vaccine to vaccinate the entire population, but definitely categorizing higher-risk groups and prioritizing them will be essential to use our resources wisely,” said Dr. Lilian Abbo, an infectious diseases expert at the University of Miami.

White House officials have promised more supplies, chiefly from the Bavarian Nordic stockpile. The U.S. recently ordered 2.5 million more doses for delivery later this year or early next. And the company says it has enough bulk ingredient to make roughly 15 million more doses for the U.S.

Last month, New York-based activists blasted the FDA for not moving more swiftly to inspect the company’s plant and begin shipping the vaccines to the U.S. In a letter to the White House, 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 for some facilities, the FDA said it conducts its own inspections for vaccines “to ensure consistency in the inspection process.”



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