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

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