Monkeypox Vaccine Manufacturing Receives USA and Europe Approvals

Denmark-based Bavarian Nordic A/S announced today that U.S. and EU regulatory authorities issued approvals to manufacture JYNNEOS® (IMVANEX®) smallpox and monkeypox vaccines at the Company's fill and finish facility in Copenhagen.

And the U.S. FDA conducted an expedited pre-approval inspection at Bavarian Nordic's facility at the beginning of July 2022.

With these approvals, Bavarian Nordic can now deliver drug products to the U.S. and EU markets.

In the USA, there is overwhelming consumer demand for this monkeypox vaccine.

As of July 23, 2022, the HHS Office of the Assistant Secretary for Preparedness and Response had delivered 310,385 Jynneos vaccines. The U.S. government has ordered about 5.9 million Jynneos vaccines. 

Paul Chaplin, President and CEO of Bavarian Nordic, stated in a press release on July 27, 2022, "We are proud to announce the successful completion of the FDA's inspection and subsequent approval of our state-of-the-art fill and finish facility along with EMA's approval."

"This achievement, which underscores the excellence of our manufacturing site and our ability to deliver high-quality vaccines for improving and saving lives, was made possible through the dedication and commitment of our talented employees."

"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.

"And we look forward to continuing our work with health authorities around the globe to ensure supply of vaccines against monkeypox."

The approval by the European Medicines Agency was granted upon assessment by the Committee for Medicinal Products for Human use of a type II-variation application submitted in June 2022, which, similar to the FDA approval, acknowledges Bavarian Nordic as the new drug product manufacturer of the IMVANEX vaccine, in supplement to the inspection, and approval earlier granted, by the Danish Medicines Agency,

Additional monkeypox vaccine news is posted at PrecisionVaccinations.com/Monkeypox.

Note The Company's announcement was manually curated for mobile readership.