FDA Clears Way To Make 786,000 Monkeypox Shots Available Thursday
World Health Organization has declared monkeypox a public health emergency of international concern.
(Bloomberg) -- Another 786,000 doses of Bavarian Nordic’s monkeypox shot will be made available to US states on Thursday as the country grapples with strained vaccine supply amid a growing outbreak, federal regulators said Wednesday.
“HHS is working to make these doses available to states and jurisdictions as soon as possible to fulfill their needs and will announce allocations tomorrow,” Department of Health and Human Services Secretary Xavier Becerra said in a statement. “Aggressively responding to the monkeypox outbreak is a critical priority for HHS.”
The US Food and Drug Administration said Wednesday that it approved a supplement to Bavarian Nordic’s biologics license for Jynneos, meaning that doses manufactured at the Denmark-based company’s fill-and-finish facility can be distributed in the US. The 786,000 doses were shipped to the US ahead of final FDA approval so that they could be made immediately available once the quality inspection was completed and manufacturing changes were approved, the FDA said in a statement.
The company also announced it had received a similar approval for Jynneos manufacturing from European regulatory authorities.
Bavarian Nordic Chief Executive Officer Paul Chaplin in a statement thanked the FDA and the European Medicines Agency for accelerating their reviews, given that the World Health Organization has declared monkeypox a public health emergency of international concern. “We look forward to continuing our work with health authorities around the globe to ensure supply of vaccines against monkeypox,” Chaplin said.
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