Pfizer postponing FDA request for COVID-19 vaccine for kids under five

Pfizer is postponing it’s rolling FDA request for emergency use of the COVID-19 vaccine for kids under 5 years of age. This means the vaccines for this age group will not be available in the near future.

According to NBC News, Pfizer said on Friday that it is waiting for its three-dose series data to come in. They believe three doses “may provide a higher level of protection in this age group.” This data is expected to arrive in early April. They reported that previous trials for two-doses did not generate a strong enough immune response in small children.

For young children, the current dosage in the Pfizer vaccine is 3 micrograms. In older children ages 5 to 11, the dosage is 10 micrograms. Pfizer had previously asked the FDA to authorize the two-dose vaccine, and planned on submitted data for the three-dose vaccine in the near future.

The FDA was also expected to publish an analysis of the data on Friday ahead of an advisory committee, but instead announced that the meeting was postponed. 

Supposedly there has been pushback from outside the agency saying that Pfizer’s data isn’t sufficient. Experts also feared their concerns were not being heard by the company. The FDA initially wanted to begin reviewing the data on the two dose vaccine as they believed it could provide just enough protection to be beneficial.

However, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that after reviewing the two-dose data, they decided they needed to see the three-dose before considering authorization.