FDA Set to Rule on COVID Shots for Youngest Kids This Week

Leigha Tierney and Damian McNamara, MA

June 14, 2022

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The FDA is gearing up for a busy week — after a busy weekend releasing information about the effectiveness and safety of both the Pfizer/BioNTech COVID-19 vaccine in children under 5 years old and the Moderna vaccine in children 6 months to 17 years of age.

This data comes just before two FDA advisory panels are scheduled to meet Tuesday and Wednesday to recommend whether or not to authorize one or both vaccines in these youngest of Americans. The FDA does not have to follow its panels' recommendations but often does so.

Early briefing documents released Friday and Saturday by the FDA shows both two-dose vaccines safe and effective in these age groups.

The Pfizer data shows their vaccine to be 75.6% effective in preventing symptomatic COVID-19 in children 6 months to 23 months old, as well as 82.4% effective for children 2- 4- years-old.

The Moderna data shows the vaccine to be 51% effective in children 6 months to 2 years old and 37% effective in children 2 years to 5 years old.

FDA documents also show that the Moderna vaccine appears safe and effective in 6- to 17-year-old children and teens. The agency noted two doses of the Moderna vaccine trigger an immune response in this age similar to the effectiveness seen in adults.

Asked to comment on the early data on the Pfizer and Moderna vaccines and their authorizations, Matthew Harris, MD, medical director for the New Hyde Park based Northwell Health COVID-19 vaccination program said "I would certainly recommend the vaccine once it becomes available."

Nothing is certain until the FDA decides, though. And if the vote is yes for one or more of these vaccines/age groups, the CDC needs to sign off as well, which could come later this week after the agency hears from two of its own advisory panels..

Harris emphasized the significance of vaccinating children against COVID-19, and the ongoing challenge to convince parents to get the shots for both their younger and older children. "We still have a long way to go for primary vaccines and boosters for children 5 years and above," he says.

If one or more of these COVID-19 vaccines receives FDA authorization, it is expected that parents can start getting their children and/or teenagers vaccinated the week of June 20. According to Harris, healthcare professionals are expecting a "surge" of COVID-19 cases in the fall season, saying that the "timing of the vaccine is important."

Sources:

Matthew Harris, MD, Pediatric Emergency Medicine physician

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