U.S., EU clear manufacturing plant for Bavarian Nordic’s monkeypox vaccine

(Reuters) -Drugmaker Bavarian Nordic 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 U.S. Food and Drug Administration’s approval for the fill-and-finish plant will lead to the availability of an additional 786,000 doses of vaccine in the United States, Health and Human Services Secretary Xavier Becerra said in a statement. (https://bit.ly/3PGKZRj)

The fill-and-finish plants fill vials with vaccine produced in bulk and then package those for distribution.

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.

In a tweet on Wednesday, the U.S. FDA 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.

(Reporting by Manas Mishra in Bengaluru; additional reporting by Leroy Leo; Editing by Aditya Soni)