FDA Postpones Adcomm For Pfizer's COVID-19 Vaccine For Youngest Kids

The FDA has postponed the Advisory Committee meeting scheduled for Pfizer Inc PFE / BioNTech SE's BNTX COVID-19 vaccine in children six months through 4 years of age, initially scheduled for February 15.

• The decision comes after a preliminary assessment of data submitted by Pfizer / BioNTech to request emergency authorization, and the agency thinks it needed more data before weighing in on approval.
• The extension allows the FDA time to receive updated data on the two and three-dose regimen, Pfizer said, while thoroughly evaluating it.
• The Company said that it would test a third dose of its COVID-19 vaccine in the trial after announcing that non-inferiority was not met for children between the ages of two and five compared to older teenagers in the current trial. 
• But for the youngest group, from 6 months to 2-years-old, non-inferiority was met.
• The first rollout for the vaccine was anticipated on February 21.
• Pfizer said in a statement that in these children, data on the first two 3 µg doses in this age group are being shared with the FDA on an ongoing basis.
• The companies expect to have three-dose protection data available in early April.
• "The independent Data Monitoring Committee (DMC) for the study supports the continuation of the trial according to the protocol and believe that the data collected to date indicate the vaccine is well tolerated and supports a potential three-dose regimen," Pfizer added.
• Pfizer clocked in a whopping $81.3 billion sales in FY21, with nearly $37 million of that coming from the Company's COVID-19 vaccine sales.
• Price Action: PFE shares are trading 1.54% lower at $50.00, and BNTX stock is down 4.97% at $162.45 during the premarket session on Monday's last check.