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US Regulators Clarify How to Increase Shipments of Monkeypox Vaccine | WGN Radio 720

Washington (AP) — Thousands of monkeypox vaccines are expected to be shipped to the United States shortly after federal health officials have announced that they have completed inspections of manufactured overseas factories.

The latest information from the Food and Drug Administration is that demand for double-dose vaccines is skyrocketing as thousands of people in New York City, California, and other parts of the United States are waiting for a chance to get an injection. It will be done in.

Over 1.1 million doses of vaccine purchased by the US government are currently located at the Bavarian Nordic facility in Denmark. Earlier this week, the company said it needed approval from an onsite FDA inspection before shipping to the United States.

An FDA spokeswoman said late Wednesday that regulators “quickly completed inspections of the company’s factories.”

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

Bavarian Nordic has already shipped 300,000 doses of vaccine from a third-party facility previously approved by the FDA.

The FDA requires prior testing to ensure the safety, infertility, and production consistency of all vaccine factories. A spokesman for one company said that after monkeypox began to spread in Europe in May, Bavarian Scandinavia hastened plans to be tested. Initially, the company submitted documents to the FDA in August and was scheduled to be inspected in the second half of the fall.

Bavarian Nordic two-shot Jynneos is one of two vaccines that can be given in the United States to prevent monkeypox. The government can use more old smallpox vaccines (ACAM2000), but it is considered at high risk of side effects and is not recommended for people infected with HIV. Therefore, the Jynneos vaccine is used by authorities as the primary weapon against outbreaks.

Most monkeypox patients experience only fever, body aches, chills, and malaise. People with more serious illnesses have rashes and lesions on their faces and hands that can spread to other parts of the body.

Most of the approximately 1,000 cases reported in the United States were between men having sex with men, but health officials have emphasized that anyone can get the disease. The number of US cases currently reported may be underestimated as testing is still increasing.

White House officials have promised more supplies, primarily from more than a million Bavarian Nordic stockpiles. The United States ordered an additional 2.5 million doses later this year or earlier next year.

Last month, a New York-based activist inspected the company’s factory and blew up the FDA for not moving faster to begin shipping vaccines to the United States. In a letter to the White House, the HIV nonprofit PrEP4All said it was approved by European regulators at the factory last year.

The FDA relies on testing by foreign regulatory agencies to review some facilities, but says the FDA is conducting its own testing of vaccines “to ensure consistency in the testing process.” I did.

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

US Regulators Clarify How to Increase Shipments of Monkeypox Vaccine | WGN Radio 720

Source link US Regulators Clarify How to Increase Shipments of Monkeypox Vaccine | WGN Radio 720

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