FDA Approve Smallpox/Monkeypox Vaccine

The FDA has approved the Jynneos vaccine by Bavarian Nordic for the prevention of Smallpox and Monkeypox in adults 18 years of age and older determined to be at high risk for these infections.

Jynneos is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus; this modified form of the vaccinia virus does not cause disease in humans and cannot reproduce in human cells. 

The effectiveness of the vaccine against smallpox was inferred by comparing the immunogenicity of Jynneos to the licensed smallpox vaccine ACAM2000 from Emergent Biosolutions. In the study, immune response with Jynneos (2 doses administered 28 days apart) was found to be noninferior to the comparator vaccine (1 dose) in healthy participants with no vaccination history for smallpox. 

The effectiveness of the vaccine against monkeypox was inferred from antibody responses in the smallpox clinical study as well as from studies of non-human primates who were exposed to the monkeypox virus following vaccination with Jynneos.

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