FDA appears poised to OK vaccine for adolescents

WASHINGTON — The Food and Drug Administration is expected by next week to grant expanded emergency use authorization to allow children as young as 12 to receive the coronavirus vaccine developed by Pfizer and German firm BioNTech, according to three federal officials familiar with the situation.

The agency is working on the authorization, said the officials, who spoke on the condition of anonymity. Shortly after the FDA decision, a Centers for Disease Control and Prevention advisory committee is expected to meet to recommend how the vaccine should be used.

The New York Times first reported that the regulatory action was pending.

Families and pediatricians have been eager for a vaccine to become available for children, particularly in advance of the next school year.

Stephanie Caccomo, a spokeswoman for the FDA, declined to comment on whether the decision has been made.

“The FDA’s review of Pfizer’s request to amend its emergency use authorization (EUA) in order to expand the age range for its covid-19 vaccine to include individuals 12-15 years of age is ongoing. We can assure the public that we are working to review this request as quickly and transparently as possible,” Caccomo said.

The FDA in December authorized the Pfizer-BioNTech vaccine for use in people 16 and older.

Pfizer announced at the end of March that it had submitted data from a trial of nearly 2,300 adolescents between 12 and 15 years old, half of whom had received the same twoshot regimen that has been shown effective and safe in adults.

The shot triggered stronger immune responses in the teens than those found in young adults. There were 18 cases of COVID-19 in the trial, all of them among adolescents who received a placebo, suggesting the two-shot regimen offered similar protection to younger recipients as it does to adults.

Children are far less likely to suffer severe illness from COVID-19, the illness caused by the novel coronavirus. About 300 children have died in the United States, out of more than 576,000 total deaths.

Trials testing the PfizerBioNTech vaccine in younger children are ongoing.

The biotech company Moderna is conducing a similar trial of its vaccine in teens, with results expected in the summer. Moderna is also testing its vaccine in younger children. Johnson & Johnson is planning pediatric trials of its single-shot vaccine.