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Pfizer Tries Again for “Emergency Use Authorization” of Its Triple-Dose COVID-19 Vaccine for Kids as Young as 6 Months

Pfizer and its partner BioNTech have resubmitted their application to have a three-dose COVID-19 vaccine for children aged 6 months to 4 years old gain “emergency use authorization” from the FDA.

The FDA reportedly accepted Pfizer’s application to look at the data on Wednesday (June 1).

Ahead of the expected submission, the FDA last week said its Vaccines and Related Biological Products Advisory Committee would meet on June 15 to discuss emergency use authorization requests for Pfizer and Moderna COVID-19 vaccines for children as young as 6 months old.

Pfizer had previously asked the FDA to authorize its vaccine for kids 6 months to 4 years in February but postponed its request pending more data.

Pfizer’s recent application to the FDA included clinical trial data that found three doses of the COVID-19 vaccine for children under 5 were safe and generated a “strong immune response,” even for the Omicron variant of SARS-CoV-2.

However, it is worth noting that this trial enrolled “children with or without prior evidence of SARS-CoV-2 infection,” which arises questions over the influence of natural acquired immunity in this age group over Pfizer’s reported vaccine efficacy results.

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