FDA OKs Bavarian Nordic’s manufacturing facility, increasing monkeypox vaccine supply
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Bavarian Nordic announced today that it has received approval from the FDA to manufacture its monkeypox vaccine Jynneos at the company’s fill and finish facility in Denmark.
“The expedited inspection and approval by FDA of Bavarian Nordic’s fill and finish capabilities means that an additional 786,000 doses of vaccine are now available for use in the U.S.,” HHS Secretary Xavier Becerra said in a press release. “This action by the FDA is a critical step forward in our plans to strengthen and accelerate our monkeypox response, which includes distributing a safe and effective vaccine to those at highest risk of exposure to monkeypox.”
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The FDA announced on Twitter that it previously facilitated the shipment of the additional 786,000 vaccine doses “so they would be ready to be distributed once the manufacturing changes were approved.”
“With this supplement approval, those manufactured doses may now be further distributed and administered,” the agency wrote. “Additional doses manufactured at this plant can help address the need for this vaccine moving forward.”
The FDA conducted the expedited pre-approval inspection in the beginning of July, according to a press release from Bavarian Nordic. The inspection included the final drug production of Jynneos, which was previously done at a contract manufacturer.
The European Medicines Agency also granted approval to Bavarian Nordic’s fill and finish manufacturing facility, according to the company.
“We are thankful to both FDA and EMA for accelerating their review during this monkeypox outbreak, which now has been named a public health emergency of international concern by the WHO,” Paul Chaplin, president and CEO of Bavarian Nordic, said in a press release. “We look forward to continuing our work with health authorities around the globe to ensure supply of vaccines against monkeypox.”
References:
Bavarian Nordic receives U.S. and EU approvals of its fill and finish vaccine manufacturing facility. https://www.bavarian-nordic.com/investor/news/news.aspx?news=6596. Published July 27, 2022. Accessed July 27, 2022.
Statement by HHS Secretary Becerra on FDA approval of additional Bavarian Nordic monkeypox vaccine. https://www.hhs.gov/about/news/2022/07/27/statement-hhs-secretary-becerra-fda-approval-additional-bavarian-nordic-monkeypox-vaccine.html. Published July 27, 2022. Accessed July 27, 2022.
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