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

Posted In: BriefsCOVID-19 CoronavirusCOVID-19 VaccineBiotechLarge CapNewsHealth CareGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.