The US Food and Drug Administration (FDA) is set to authorize the Pfizer-BioNTech COVID-19 vaccine for adolescents ages 12 to 15 by early next week, according to a New York Times report.
The agency is expected to expand its emergency use authorization for Pfizer’s vaccine by early next week.
Following the authorization, the Centers for Disease Control and Prevention’s (CDC) vaccine advisory panel will discuss whether to recommend the vaccine for 12- to 15-year-olds, according to The Times report.
Pfizer announced in late March that a clinical trial involving more than 2,000 adolescents ages 12-15 showed it was “well tolerated.”
Volunteers experienced about the same side effects seen in people ages 16 to 25, it added.
The vaccine is currently authorized in the US for use under an EUA in individuals 16 years of age and older.
Also in March, Pfizer CEO Albert Bourla said that the company shared “the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15.”
Stephanie Caccomo, a spokeswoman for the FDA, declined to comment on the timing of the agency’s decision.
“We can assure the public that we are working to review this request as quickly and transparently as possible,” the spokeswoman told The Times.
FDA Director General Eric Domingo on Tuesday said they are expecting that the US drugmaker will also apply for the expansion of the EUA in the Philippines for its vaccine.
“We are expecting na magpapa-approve na rin sila for 12 to 15 dito sa atin, kaya lang hindi pa kasi dumarating ‘yung pinakaunang order natin ng Pfizer (We are expecting that they will also ask for approval here to include 12 to 15 years old. However, our first order of Pfizer vaccine has not arrived yet),” Domingo said in an interview with DZBB.
More than 140 million Americans have received at least one dose of coronavirus vaccine as of May 3, according to the data from the CDC.