Bavarian Nordic’s Jynneos Vaccine Receives FDA’s Approval to Prevent Smallpox and Monkeypox Disease in Adults

Bavarian Nordic’s Jynneos Vaccine Receives FDA’s Approval to Prevent Smallpox and Monkeypox Disease in Adults

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  • The US FDA has approved Jynneos as the first non-replicating smallpox (in the US) & monkeypox vaccine to prevent smallpox and monkeypox disease in patients aged≥ 18yrs. determined to be at high risk for smallpox or monkeypox infection and has granted Priority Review Voucher to Bavarian which is transferrable
  • The approval for smallpox is based on development program assessing Jynneos vs ACAM2000 in 7871 individuals aged 18 to 80yrs., resulted in non-inferiority in terms of immunogenicity measured by plaque reduction neutralization test. The approval for monkeypox is based on survival data obtained in lethal monkeypox virus challenge sin non-human primates
  • Jynneos (SC,0.5ml) is a suspension based on a live, non-replicating attenuated vaccinia virus (Modified Vaccinia Ankara, MVA-BN), developed in partnership with US Department of Health and Human Services

Click here to­ read full press release/ article | Ref: Bavarian Nordic | Image: Twitter