FDA set to rule on COVID shots for youngest children this week

June 13, 2022 – FDA gears up for a busy week – after a busy weekend releasing information on the effectiveness and safety of both the Pfizer/BioNTech COVID-19 vaccine in children under 5 and the Moderna vaccine in children aged 6 months to 17 years.

This data comes just before two FDA advisory panels are scheduled to meet Tuesday and Wednesday to recommend whether or not one or both vaccines should be approved in these youngest Americans. The FDA is not required to follow the recommendations of its panels, but often does.

Early briefing papers released Friday and Saturday by the FDA show that two-dose vaccines are safe and effective in these age groups.

Pfizer’s data shows that their vaccine is 75.6% effective in preventing symptomatic COVID-19 in children 6 months to 23 months of age, as well as 82.4% effective in children 2 to 4 years of age.

The data from Moderna shows that the vaccine is 51% effective in children aged 6 months to 2 years and 37% in children aged 2 to 5 years.

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

Asked for comment on the early data on the Pfizer and Moderna vaccines and their authorizations, Matthew Harris, MD, medical director of the New Hyde Park-based Northwell Health COVID-19 Vaccination Program, said: “I would definitely recommend the vaccine as soon as it becomes available.”

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

Harris emphasized the importance of vaccinating children against COVID-19 and the ongoing challenge of convincing parents to get the injections for both their younger and older children. “We still have a long way to go for primary vaccines and boosters for children ages 5 and older,” he says.

If one or more of these COVID-19 vaccines are approved by the FDA, parents are expected to begin vaccinating their children and/or teens by the week of June 20. According to Harris, healthcare professionals are expecting a “wave” of COVID-19 19 cases in the fall season, saying “vaccine timing is important.”