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Drugmaker Bavarian Nordic said U.S. and European regulators have approved the use of Jynneos vaccine doses made at the company’s Danish plant as global efforts to tackle the monkeypox outbreak gather pace.
The US Food and Drug Administration’s approval of the filling and finishing plant will make an additional 786,000 doses of the vaccine available in the United States, Health and Human Services Secretary Xavier Becerra said in a statement. (
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Filling and finishing facilities fill vials with bulk vaccine and then package them for distribution.
The vaccine is already approved for use in the United States and Europe to prevent smallpox and monkeypox in adults.
More than 18,000 cases of monkeypox have been reported worldwide from 78 countries, with the majority in Europe, according to the World Health Organization. The UN health agency has declared a state of emergency due to the epidemic.
In a tweet on Wednesday, the US FDA said it has already facilitated the shipment of manufactured doses to be prepared for distribution once manufacturing changes are approved.
“Additional doses produced at this facility may help address the need for this vaccine going forward,” the FDA said.
Bavarian has received orders for millions of doses from around the world, including nearly 7 million doses of vaccines this year and to the United States. (Reporting by Manas Mishra in Bengaluru; Additional reporting by Leroy Leo; Editing by Aditya Soni)
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