In a significant update for parents, Pfizer announced today, September 28, that it has submitted preliminary data to the FDA regarding its COVID-19 vaccine trial involving children aged 5 to 11. This development brings us closer to the potential authorization of the vaccine for this age group, a long-awaited milestone for many families.
While this submission does not constitute a formal request for emergency use authorization (EUA), Pfizer indicated that such a request could follow in the upcoming weeks. This aligns with recent comments from former FDA Commissioner Scott Gottlieb, who suggested that if all goes well, the vaccine could receive authorization by the end of October.
The announcement follows promising results from Pfizer’s trial, which showed the vaccine had a “favorable safety profile and robust neutralizing antibody responses” in children. The doses used in the trial for this younger demographic were one-third the size of those administered to adults.
On September 10, FDA officials expressed their eagerness to see children vaccinated against COVID-19. They emphasized the importance of relying on scientific data to guide the process. The officials noted that the FDA is diligently working to expedite the availability of COVID-19 vaccines for children while ensuring safety is not compromised. They reassured the public that once a complete EUA application is submitted, the FDA would thoroughly and swiftly review the data to assess its benefits and risks.
Pfizer also mentioned that results for the next age group, children under 5, may be available by the fourth quarter of this year.
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In summary, Pfizer’s recent submission of COVID vaccine data for children ages 5-11 is a promising step toward potential authorization. The FDA is actively working to ensure a thorough review process, with hopes of making the vaccine available soon for younger populations.
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