The US Food and Drug Administration said on Friday that it would wait for more data on the Pfizer-BioNTech SARS-CoV-2 vaccine for young children before deciding whether to authorize it, the New York Times reports.
This, it notes, is a departure from what the agency previously signaled it would do. As the Washington Post reported earlier this month, studies from Pfizer and BioNTech had shown that while two vaccine doses led to an immune response among very young children between 6 months of age and 2 years, two doses did not generate the needed immune response in children between 2 years and 4 years old. According to the Post, the companies are testing whether a third dose might boost that response further, and the FDA encouraged them to submit the two-dose data so that vaccinations could begin quickly.
According to the Times, Pfizer and BioNTech asked for the delay following additional data indicating that the Omicron variant led to an even higher infection rate after two doses. This, NPR reports, led FDA's Peter Marks to decide to wait for the third dose data before making any decisions.