Pfizer and BioNTech’s COVID-19 Vaccine Receive the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19
Pfizer Reports Interim Results of Paxlovid (COVID-19 Oral Antiviral Therapy) in P-II/III EPIC-HR Study for the Treatment of COVID-19
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