FDA, Pfizer postpone review of vaccine for children under age 5

A meeting of the FDA’s COVID advisory panel set for next week has been canceled after Pfizer essentially paused its application to the FDA, saying it will now wait on additional data regarding a third dose of the vaccine for children under 5. The move means that vaccines for that age group will not be available in the coming weeks.

A meeting of the FDA’s COVID advisory panel set for next week has been canceled after Pfizer essentially paused its application to the FDA, saying it will now wait on additional data regarding a third dose of the vaccine for children under 5.

The move means that vaccines for that age group will not be available in the coming weeks.

It’s a major setback for parents anxious to vaccinate their younger children against COVID. Pfizer is postponing its rolling application to the FDA to expand the use of its two-dose vaccine for children 6 months to 4 years.

Pfizer said it will wait for its data on a three-dose series of the vaccine, because it believes three doses may provide a higher level of protection in that age group. Data on the third dose is expected in early April.

Pfizer said in December that two doses didn’t generate a strong enough immune response in its trial of children ages 2 to 4. For young children, Pfizer’s vaccine has a dosage of 3 micrograms. For children ages 5 to 11, the dosage is higher -- at 10 micrograms.

Still, the company asked the FDA this month to authorize these first two doses with a plan to submit additional data in the coming weeks on a third dose. The full vaccination series would be three doses.

The FDA was expected to publish an analysis of the Pfizer data Friday, ahead of an advisory committee meeting next week.

Read: Complete Michigan COVID coverage


About the Author:

Kimberly Gill joined the Local 4 News team in November 2014. She was named Personality of the Year in 2009 by the Ohio Broadcaster’s Hall of Fame. She’s also a two-time Emmy winner.