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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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