February 2, 2022 – The Washington Post reports that Pfizer and BioNTech have submitted an emergency-use authorization request to the FDA for the two-dose COVID vaccine for children ages 6 months to 5 years old. Both companies have begun to submit data on the “safety and efficacy” of the first two doses of COVID vaccine.
While the data has not yet been published or peer-reviewed, the FDA has requested the companies to move forward with an application because of the “urgent public health need in this population.”
Pfizer CEO Albert Bourla said in a statement, “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. 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.”
Outside advisors will form a committee to review the data in the next few weeks, which will likely influence the FDA’s decision. The CDC’s advisory committee will also look review the data. An EUA for the Pfizer-BioNTech vaccine could approved by the end of February.