- The FDA has granted emergency use authorization (EUA) to Pfizer Inc (NYSE:PFE) and BioNTech SE's (NASDAQ:BNTX) COVID-19 Vaccine as a three 3-µg dose series for children six months through 4 years of age.
- Based on safety, tolerability, and immunogenicity data, the 3-µg dose was carefully selected as the preferred dose for children under five.
- The EUA is based on data from a Phase 2/3 trial that included 4,526 children six months through 4 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when omicron was the predominant variant.
- Following the third dose in this age group, the vaccine elicited a robust immune response, with a favorable safety profile similar to a placebo.
- No new safety signals were identified, and the frequency of adverse reactions observed in children six months through 4 years was generally lower than in children 5 through 11 years.
- Pfizer and BioNTech will begin shipping 3-µg pediatric doses as directed by the U.S. government.
- The companies plan to submit requests for authorization of their COVID-19 vaccine in this age group to other regulators worldwide, including the European Medicines Agency, in early July.
- Price Action: PFE shares are down 1.11% at $46.96, and BNTX stock is down 0.77% at $128.66 during the market session on the last check Friday.
- Image by x3 from Pixabay
