Pfizer and BioNTech Submit Data to FDA for COVID-19 Vaccine in Younger Children

As expected, Pfizer and BioNTech have announced the submission of data to the FDA from the Phase 2/3 trial of their COVID-19 vaccine in younger children.

Earlier this month, the two companies shared positive toppling results from a trial comprised of 2,268 participants between the ages of 5 and 11. In that group, the vaccine showed a strong safety profile and brought about “robust neutralizing antibody responses” by way of its two-dose regimen.

Notably, the results—broken down in greater detail in our previous coverage here—were on par with those seen in a prior study for older ages (i.e. 16 to 25). Younger children were given smaller doses than those used in vaccines administered to people 12 years of age and older.

The latest data has been sent to the FDA for an initial review, with Pfizer saying Tuesday that a formal request for Emergency Use Authorization for children ages 5 to 11 will be announced “in the coming weeks.” Similarly crucial submissions to other regulatory agencies, including the EMA, are also expected.

Speaking on the relevant trial results earlier this month, Pfizer CEO Albert Bourla pointed to a recent uptick in pediatric COVID-19 cases as one of the key reasons why extending the vaccine protection to younger children is so important.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S.—underscoring the public health need for vaccination,” Bourla said at the time. “These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”

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