- Oops!Something went wrong.Please try again later.
Parents will then be allowed to get their children vaccinated as soon as the CDC director signs off on that recommendation.
The decision that the two-shot vaccine is safe for adolescents will allow millions more Americans to be vaccinated, which is essential if the country is to reach herd immunity.
The decision was also eagerly awaited by parents, teachers and health professionals ahead of the summer vacation and the new school term starting later this year.
“The FDA’s expansion of the emergency use authorisation for the Pfizer-BioNTech Covid-19 vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the Covid-19 pandemic,” said Acting FDA Commissioner Janet Woodcock.
“Today’s action allows for a younger population to be protected from Covid-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic.
“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our Covid-19 vaccine emergency use authorisations.”
Children have hardly been impacted by Covid-19, with officials saying that of the 581,000 Covid-19 deaths in the US during the pandemic, just 300 have been in people under the age of 18.
But the FDA says that number is still higher than the number of children who would die of flu each year.
The Pfizer vaccine was already approved for adolescents aged 16 and over, and now the other vaccine manufacturers could soon follow.
The FDA made its decision based on a Pfizer trial of nearly 2,300 youngsters aged 12 to 15, with researchers finding that the age group actually had a stronger immune response than young adults.
“Having a vaccine authorised for a younger population is a critical step in continuing to lessen the immense public health burden caused by the Covid-19 pandemic,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”