Pfizer and BioNTech Receive the US FDA’s EMA for COVID-19 Vaccine in Adolescents

May 11, 2021 Auto Bot Adolescents, BioNTech, Covid-19 Vaccine, EUA, FDA, Pfizer, regulatory 0

Shots:

  • The FDA has expanded the EUA for Pfizer’s COVID-19 vaccine in adolescents based on the data from the P- III trial in 2,260 participants aged 12-15yrs. which showed 100% efficacy and was well-tolerated. The submission of data in children aged 6mos.- 2yrs. are expected in Q4’21
  • The companies have submitted the data in adolescents for peer review and also submitted to EMA and other global regulators, expected in coming wks.
  • Additionally, the ongoing pediatric study evaluating the safety and efficacy of COVID-19 vaccine in children aged 6mos. to 11 yrs. The companies plan to submit for a EUA or conditional marketing authorizations in children aged 2-5 yrs. and 5-11yrs. in Sept’2021

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

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