Washington: The US Food and Drug Administration (FDA) is planning to open Pfizer-BioNTech coronavirus vaccine for adolescents aged 12 to 15 years by early next week, according to federal officials, the media reported.
The FDA authorisation would be a welcome news to parents anxious to protect their children, The New York Times reported.
Earlier in March, results of a clinical trial led by the companies showed that the Pfizer-BioNTech coronavirus vaccine is extremely effective in young adolescents, even more than in adults. The children produced strong antibody responses and experienced no serious side effects.
Vaccinating adolescents may also be key to boost immunity levels in the general population and thus reduce the number of hospitalisation and death, the report said.
“We can assure the public that we are working to review this request as quickly and transparently as possible,” Stephanie Caccomo, a spokeswoman for the FDA, was quoted as saying by the NYT.
Caccomo, however, said she could not comment on the timing of the agency’s decision.
The FDA authorisation is also likely to ease concern among middle school and high school administrators planning for opening schools by later this year. If students are able to be vaccinated by then, that could allow more normal gatherings and let administrators plan further ahead in the academic year, the report said.
The Pfizer and Moderna vaccines both require two doses. Pfizer is authorised for ages 16 and up, while Moderna is authorised for ages 18 and up.
Moderna is also expected to announce results from its own clinical trial involving adolescents ages 12 to 17, followed by results for children 6 months to 12 years old later this year, the report said.