Pfizer is postponing its request to the FDA to expand the use of its two-dose COVID-19 vaccine for children ages 6 months to 4 years.
Pfizer announced on Friday (Feb. 11) that it will instead wait for data on a three-dose series of its COVID-19 vaccine before asking for authorization.
Pfizer said in December that two doses didn’t generate a strong enough immune response in its trial of children ages 2 to 4. Still, the company decided to ask the FDA to authorize these first two doses anyway, with a plan to submit additional data on the third dose in April, the company said.
The FDA was expected to publish an analysis of Pfizer’s two-dose data today, ahead of an advisory committee meeting next week. The meeting has now been postponed.
Two people familiar with the FDA’s plans said there had already been a lot of pushback from vaccine experts with concerns that Pfizer’s data wasn’t sufficient.