Wednesday, March 22

Children under 5 in the US, closer to Pfizer’s COVID vaccine; approval may come in February

Pfizer and its partner BioNTech have begun submitting data to EU regulators for authorization of their COVID vaccine. in children 6 months to 4 years, according to people familiar with the matter, speeding up an effort to vaccinate younger children after the omicron variant caused a spike in pediatric cases.

The companies have begun the process of seeking an emergency use authorization from the US Food and Drug Administration (FDA) for the vaccine in children under 5, according to the people, who asked not to be named. because the details are not public.

Washington Post reported for the first time on Monday about the possibility that companies could request an authorization earlier than expected. Sources told the newspaper that approval could come even this month.

The data filing paves the way for regulators to approve the shot as a two-dose vaccine, though it is expected that it will ultimately a regimen of three injections become the standard.

Representatives for Pfizer could not be immediately reached for comment. The White House declined to comment.

The ‘impact’ of omicron

The request came earlier than expected: data released by companies in December suggested that the ability of two doses to prevent infections was mixed and that companies would need to collect more data before applying for authorization

The companies then said they would study a third dose and, if successful, would seek emergency US authorization in the first half of 2022.

Parents have been pushing the Biden administration and companies to move faster to approve vaccines for younger children. With the rise in cases this winter, more girls and boys have been infected with the SARS-CoV-2 virus, complicating child care and parents’ efforts to stay in their jobs. At the same time, however, there are signs that families are more cautious about vaccinating younger children.

While vaccines have been available for children ages 5 to 11 for several months, vaccination rates in that group remain lower than in older demographics, even amid signs that omicron poses a higher disease risk to children. Virus cases among children have risen since omicron was first detected in the US in December, and pediatric hospitalizations hit a record late last year.

The FDA is expected to convene an expert advisory panel to consider the evidence on Pfizer’s injection for younger children, probably end of this month. The agency is not bound by the group’s advice, but generally adheres to it. An expert group advising the CDC on vaccine policy is also likely to meet.