U.S., EU clear manufacturing plant for Bavarian Nordic’s monkeypox vaccine
July 27 (Reuters) – Drugmaker Bavarian Nordic (BAVA.CO) said U.S. and European regulators have approved the use of Jynneos vaccine doses made at the company’s plant in Denmark as global efforts to tackle the monkeypox outbreak pick up pace.
The vaccine is already approved for use in the United States and Europe for the prevention of smallpox and monkeypox disease among adults.
More than 18,000 cases of monkeypox have been reported globally from 78 countries, with the majority in Europe, according to the World Health Organization. The U.N. health agency has declared an emergency over the outbreak. read more
In a tweet on Wednesday, the U.S. Food and Drug Administration said it had already facilitated the shipment of manufactured doses to prepare for distribution once the production changes were approved.
“Additional doses manufactured at this plant can help address the need for this vaccine moving forward,” the FDA said.
Bavarian has received orders for millions of doses from across the globe, including nearly 7 million vaccine doses this year and next to the United States. read more
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