Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Nod For Kids As Young As Six Months

  • The FDA has granted emergency use authorization (EUA) to Pfizer Inc PFE and BioNTech SE's 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
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechLarge CapNewsHealth CareGeneralBriefsCOVID-19 CoronavirusCOVID-19 Vaccine
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!