FDA Set to Approve Pfizer COVID Vaccine for 12-15 Year Olds by Next Week: Report
The Food and Drug Administration is expected to authorize the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12 to 15 by early next week, according to a new report.
The authorization could come as soon as the end of this week, the New York Times reported on Monday. If the FDA gives the green light, the Centers for Disease Control and Prevention’s advisory panel will likely convene the next day to review the clinical trial data and make recommendations for the shots’ use in adolescents, the report says.
The news comes weeks after Pfizer announced results from its trial in adolescents showed the vaccine is at least as effective in that age group as it is in adults. As of now, the Pfizer vaccine has been authorized for use in individuals aged 16 and older.
The drugmaker reported that none of the adolescents who received the vaccine in its clinical trial developed symptomatic infections. Pfizer announced in late March that participants showed strong antibody responses and experienced similar side effects to those seen in people ages 16 to 25.
“We can assure the public that we are working to review this request as quickly and transparently as possible,” Stephanie Caccomo, a Food and Drug Administration spokeswoman said, according to the Times.
Moderna is also expecting results from its own clinical trial involving adolescents ages 12 to 17 soon, as well as results for children 6 months to 12 years old in the second half of 2021.
Such approval would help bring the country closer to reaching herd immunity and would likely help ease the concerns of vaccinated adults who have been stuck in limbo, unsure how to return to a level of normalcy with their unvaccinated children.
