U.S. Regulators Clear Way for More Monkeypox Vaccine Shipments – JEMS: EMS, Emergency Medical Services

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People line up to receive the monkeypox vaccine at San Francisco General Hospital in San Francisco on Tuesday, July 12, 2022. (Jessica Christian/San Francisco Chronicle via AP)

By MATTHEW PERRONE AP Health Writer

WASHINGTON (AP) — Thousands of additional 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 factory where they were made.

The Food and Drug Administration’s update comes amid growing frustration over limited access to the two-dose vaccine as thousands of people in New York, California and other parts of the United States are waiting for a chance to get vaccinated.

The US government has purchased more than 1.1 million full doses of the vaccine produced by Bavarian Nordic in Denmark. But the company said earlier this week that it needed clearance for an on-site inspection from the FDA before it could start shipping most of them to the United States.

JEMS: What you need to know about Monkeypox

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 doses that were manufactured in a third-party facility that had already been inspected by the FDA.

State and local authorities in the United States say the limited supply of vaccines is not keeping up with the growing number of people asking for appointments, a gap that is fueling anxiety about the virus.

“The demand has been very, very high – overwhelming, at this point,” said Dr. Mary Foote, of the New York Department of Health. “We just want to clarify: if we have the vaccine, we can administer it. The critical issue here right now is supply.

Earlier this week, New York City’s immunization appointment scheduling system crashed due to online traffic.

The US government has shipped 132,000 doses of the vaccine to health departments, including more than 21,000 in New York and 44,000 in California. Federal authorities distribute the vaccines based on the number of cases in each region and the part of the population that is most at risk of contracting the virus.

Most of the roughly 1,000 reported cases in the United States have been in 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 as testing continues to ramp up. US officials are partnering with several large commercial testing labs and say they expect to be able to process 70,000 tests a week by the end of the month.

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

The FDA requires prior inspections of all vaccine factories to ensure their safety, sterility and consistency of production. A company spokesperson said Bavarian Nordic had accelerated its plans to undergo inspection after monkeypox began spreading in Europe in May. Initially, the company planned to submit its documents to the FDA in August for inspection later in the fall.

Bavarian Nordic’s Jynneos is one of two vaccines that can be given in the United States to prevent monkeypox. The government has many more doses of the other vaccine – an older smallpox vaccine called ACAM2000 which is considered to have a greater risk of side effects and is not recommended for people living with HIV. It is therefore the Jynneos vaccine that officials are using as their main weapon against the epidemic.

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

“There are not enough vaccines to immunize the entire population, but definitively categorizing high-risk groups and prioritizing them will be key to using our resources wisely,” said health expert Dr Lilian Abbo. infectious diseases at the University of Miami.

White House officials have promised more supplies, mostly from the northern Bavarian stockpile. The United States recently ordered an additional 2.5 million doses for delivery later this year or early next year. And the company says it has enough bulk ingredients to manufacture about 15 million more doses for the United States.

Last month, New York-based activists criticized the FDA for not moving faster to inspect the company’s factory and begin shipping vaccines to the United States. In a letter to the White House, the nonprofit organization PrEP4All noted that European regulators 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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AP Medical Writer Mike Stobbe contributed to this story from New York

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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.

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