April 10, 2021
Pfizer and BioNTech filed a request with the Food and Drug Administration to expand its emergency use authorization for its vaccine to teens aged 12 to 15.
The FDA says it will evaluate the request "as quickly as possible."
"While the FDA cannot predict how long our evaluation of the data and information will take, we will review the request as expeditiously as possible using our thorough and science-based approach," Woodcock said on Twitter.
The companies released results from its trial for teens in that age group that found its vaccine was "extremely effective" and safe for young teens.
Of the 2,260 participants, there were no cases of COVID-19 reported among those fully vaccinated. The companies said the side effects experienced were comparable to what adults experienced.
The FDA likely won't have its COVID-19 advisory committee convene before the approval, CNN reported.
Health officials say in order to reach herd immunity, when enough people in a community have antibodies against the disease, children will have to be vaccinated.
“We share the urgency to expand the use of our vaccine,” Pfizer CEO Albert Bourla said in a statement.
As Pfizer has announced, the FDA has received the company’s request to amend its emergency use authorization (EUA) in order to expand the age range for its #COVID19 vaccine to include individuals 12-15 years of age. The current authorization includes individuals 16 and up.— Dr. Janet Woodcock (@DrWoodcockFDA) April 9, 2021
The FDA previously granted Pfizer and BioNTech's vaccine authorization for those aged 16 and up late last year.
Pfizer and BioNTech said they plan on requesting approval from world-wide authorities in the next few weeks. The other two vaccine candidates available, Moderna and Johnson & Johnson, are approved for those 18 and older.