Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

 Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Shots:

  • The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants
  • In P-I study, BNT162b2 (@7days after the second dose of 30μg) elicited SARS-CoV-2–neutralizing GMTs in younger adults (18-55yrs.) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age), it elicited a neutralizing GMT 1.6 times the GMT of the same panel
  • The companies anticipate commencing the global (Ex- China) P-II/III study of BNT162b2 in up to 30,000 participants that started in Jul’2020, which has to date enrolled 11,000+ patients including in areas with significant SARS-CoV-2 transmission

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

Related News: Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

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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