On Wednesday, July 27, 2022, the US Food and Drug Administration (FDA) gave approval to the plans of Bavarian Nordic to ramp up production of its JYNNEOUS vaccine that is used in efforts to halt a global outbreak of monkeypox disease.
This move comes as monkeypox cases increase globally, which forced the World Health Organization (WHO) to designate it as a global Public Health Emergency. Previously, the World Health Organization (WHO) had declared the monkeypox virus spread as a global pandemic.
The US health agency said the US FDA is announcing that it has approved a supplement to the biologics licence for the JYNNEOUS Vaccine, which is approved to prevent people from smallpox and monkeypox, to provide access for to additional production capabilities at one of the plants where the vaccine is produced.
The US health agency said that inspection was a necessary task to help ensure the safety and quality of the vaccine. The US FDA further informed us that with this supplement approval, the manufactured doses of the vaccine may be further distributed and administered, and the additional manufactured doses at the plant can help address the need for the vaccine moving forward.
The US Department of Health and Human Services said hundreds of thousands of JYNNEOUS vaccine doses, from Bavarian Nordic will be made available under the new plan of the US government through a tiered-allocation system.