Pfizer and BioNTech’s COVID-19 Vaccine Receive the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

October 27, 2021 Auto Bot BioNTech, Covid-19 Vaccine, EUA, FDA, Pfizer, regulatory 0

Shots:

  • The US FDA’s VRBPAC voted 17 to 0 with 1 abstention in favor of recommending the EUA for COVID-19 vaccine in children aged 5 to <12yrs. with COVID-19
  • The committee reviewed the P-II/III trial for the COVID-19 vaccine which showed a 90.7% vaccine efficacy in patients without prior SARS-CoV-2 infection @7 Days after 2nd dose, favorable safety profile & robust immune responses. Additionally, patients have received a two-dose regimen of 10-µg doses which was given 21 days apart while ⅓ of the 30-µg dose was used for patients aged 12yrs.
  • If the US CDC’s ACIP grants EUA, Pfizer-BioNTech COVID-19 Vaccine will be the 1st vaccine to be authorized in the US for use in patients aged 5 to <12yrs.

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: The Wall Street Journal

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