WASHINGTON (AP) – Thousands more doses of monkeypox vaccine are expected to begin shipping to the US soon after federal health officials said they have completed an inspection of the overseas plant where they were manufactured.
The Food and Drug Administration’s update comes amid rising demand for the two-dose vaccine as thousands in New York CityA chance awaits to take the shot in California and other parts of the US.
More than 1.1 million doses of the vaccine purchased by the US government are currently in a Bavarian Nordic facility in Denmark. The company said earlier this week that it needed authorization from an on-site FDA inspection before shipping it to the US.
An FDA spokesperson 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 of the vaccine that were made in a third-party facility previously authorized by the FDA.
The FDA requires pre-inspection at all vaccine plants to ensure safety, sterility, and continuity of production. A spokesman for the company said the Bavarian Nordic intensified its plans to undergo inspections after the monkeypox outbreak in Europe in May. The company initially planned to submit its paperwork to the FDA in August for inspection later in the fall.
Bavarian Nordic’s two-shot Genios is one of two vaccines Which can be given to prevent monkeypox in America. The government has several more doses of the older smallpox vaccine – ACAM2000 – which can also be used, but is considered to have a higher risk of side effects and is not recommended for people with HIV. So This Is The Jynneos Vaccine That Officials Are Using as a primary weapon against outbreaks.
Most monkeypox patients only experience fever, body aches, chills, and fatigue. People with more severe disease may have a rash and sores on the face and hands that can spread to other parts of the body.
Most of the nearly 1,000 cases reported in the US are in men who have sex with men, but health officials say anyone can get the disease. The current number of reported US cases is likely to be low as testing is still ramping up.
White House officials have promised more supplies, mainly from the more than 1-million-dose Bavarian Nordic stockpile. The US has ordered another 2.5 million doses for delivery by the end of this year or early next year.
Last month, New York-based activists rebuked the FDA for not moving more quickly to inspect the company’s plant and begin shipping the vaccines to the US. Last year at the plant.
While the FDA relies on inspections by foreign regulators to review some facilities, the FDA said it conducts its own inspections for vaccines “to ensure consistency in the inspection process.”
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