Shots:

• The approval is based on the longer-term follow-up data from the P-III trial that showed high efficacy and favorable safety profile through 6mos. after the second dose
• The vaccine will now be marketed as Comirnaty and is fully approved for the prevention of COVID-19 in individuals aged ≥16 yrs. The companies also plan to license a third or booster dose of Comirnaty in the same age group through sBLA
• The vaccine continues to be available under a EUA for individuals aged 12-15 yrs. and for the administration of the third dose in immunocompromised patients. The companies plan to submit an sBLA to support full FDA approval of the vaccine in individuals aged 12-15 yrs.

Click here  | Ref: Pfizer | Image: Wall Street Journal