Bavarian Nordic’s Danish Manufacturing Plant FDA-Inspected for Jynneos Monkeypox Vaccines

The FDA has inspected a Bavarian Nordic manufacturing facility in Denmark which manufactures a monkeypox vaccine that’s now awaiting the agency’s green light to ship to the United States.

Upon approval of the facility, close to 800,000 doses of the Jynneos vaccine are expected to be distributed to the U.S. The distribution is expected to occur by the end of this month.

A separate vaccine manufactured by Emergent BioSolutions, ACAM2000, is also cleared by the FDA for monkeypox prevention, but is not recommended for use in pregnant women and in individuals with weakened immune system and atopic dermatitis.

Currently, the U.S. has an ample supply of the ACAM2000 vaccine, but only a limited supply of the Jynneos vaccine.

As of July 12, there were 929 confirmed cases of monkeypox infection in the U.S., according to the Centers for Disease Control and Prevention.