Pfizer Reports the US FDA’s Acceptance and Priority Review of BLA for Ticovac (Tick-Borne Encephalitis Vaccine)

February 24, 2021 Auto Bot Acceptance, BLA, FDA, Pfizer, Priority Review, regulatory, reports 0

Shots:

  • The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in Aug 2021. If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas
  • The BLA is based on clinical trials that assess TicoVac across two age groups (aged 1-15yrs. and 16-65yrs.). The studies showed pooled seropositivity rates 99-100% and 94-99% following three doses respectively
  • The real-world studies demonstrated that the vaccine is 96-99% effective in people who have received at least 2 doses of the vaccine and 2-3 doses of the vaccine were shown to be sufficient to provide a long-lasting immune memory

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Pfizer

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