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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 plant in Denmark as global efforts to deal with the smallpox outbreak in monkey increase the pace.
The US Food and Drug Administration’s approval of the filling and finishing plant will make 786,000 additional doses of vaccine available in the United States, Health and Human Services Secretary Xavier Becerra said in a statement (
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Filling and finishing plants fill the vials with the vaccine produced in bulk and then package them 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.
According to the World Health Organization, more than 18,000 cases of monkeypox have been reported worldwide in 78 countries, most of them in Europe. The UN health agency has declared an emergency over the outbreak.
In a tweet on Wednesday, the US FDA said it had already facilitated the shipment of manufactured doses to prepare for distribution once production changes are approved.
“Additional doses manufactured at this plant may help address the need for this vaccine moving forward,” the FDA said.
Bavaria has received orders for millions of doses from around the world, including almost 7 million doses of vaccines this year and next to the United States. (Reporting by Manas Mishra in Bangalore; Additional reporting by Leroy Leo; Editing by Aditya Soni)