Today Pfizer and BioNTech submitted an emergency use authorization (EUA) application to the Food and Drug Administration (FDA) for their mRNA COVID-19 vaccine for use in children 6 months to 4 years — the last age-group ineligible for COVID-19 vaccination in the United States.Anonymous sources told the Washington Post the FDA was eager to review the application and hoped shots could be in the arms of this cohort as soon as the end of the month.
Data on a third dose of vaccine in this age-group are expected in March.Late last year, Pfizer reported that the two-dose regimen of vaccine was safe in children 6 months to 5 years, but was not as effective at preventing infection compared to other cohorts.Three doses likely needed"Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants," said Albert Bourla, chairman and chief executive officer of Pfizer in a press release. "If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose."The EUA is based on results from a trial which saw participants get two doses of 3-microgram shots—a tenth of the dose given to adults—3 weeks apart.
Results from the trial should be released when the EUA application is submitted.In related news, Novavax said it had submitted an EUA application for its protein-based COVID-19 vaccine, to be used in adults."We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight