FDA clears way for more monkeypox vaccine shipments to US – NBC Chicago

Thousands of more doses of monkeypox vaccine are expected to start 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 demand for the two-dose vaccine as thousands of people in New York, California and other parts of the United States wait for a chance to to get vaccinated.

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

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 manufactured in a third-party facility that had already been cleared by the FDA.

Symptoms take 7-14 days to appear, but can take up to 21 days to appear

The FDA requires pre-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 two-shot Jynneos is one of two vaccines that can be given in the United States to prevent monkeypox. The government has many more doses of an older smallpox vaccine – ACAM2000 – which can also be used, but 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.

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.

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 U.S. cases is likely an undercount as testing continues to ramp up.

Monkeypox is not classified as a sexually transmitted disease

White House officials have pledged more supplies, mostly from the Northern Bavarian stockpile of more than a million doses. The United States has ordered an additional 2.5 million doses for delivery later this year or early next year.

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 to review certain facilities, the FDA said it conducts its own inspections for vaccines “to ensure consistency in the inspection process.”

NBC Chicago

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