Pfizer reports strong COVID vaccine protection in kids under 5, will file with FDA

In closely watched developments, especially among parents and healthcare providers, Pfizer and BioNTech today announced strong efficacy for a three-dose regimen of the child-sized dose of their mRNA vaccine in kids ages 6 months to 4 years old.Moving forward with 3-dose seriesThe new findings come more than 3 months after the two companies abruptly delayed submitting the emergency use authorization (EUA) application for the vaccine to allow them more time to evaluate whether a two- or three-dose primary series would be best.The 3-microgram dose for the smallest children is one-tenth of the adult dose and was selected for its safety, tolerability, and immunogenicity.

Earlier trials, however, found that the reduced dose didn't prompt a significant immune response in children 2 years and older, suggesting that a third dose may be needed.In a statement today, the companies said the third dose was well tolerated among 1,678 children under age 5, with a safety profile that was similar to placebo.

Vaccine efficacy was 80.3% at a time when the Omicron variant was dominant.Ugr Sahin, MD, BioNTech's chief executive officer and cofounder, said officials from the two companies are preparing documents and expect to submit the EUA application to the US Food and Drug Administration (FDA) later this week, with submission to the European Medicines Agency and other regulatory agencies in the coming weeks.Given the new timeline for expected submissions, the FDA today said its vaccine advisory group will meet on Jun 14 to discuss Moderna's EUA request for kids ages 6 through 17.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Jun 15 to talk about both Moderna's EUA request for kids age 6 months through