US FDA approves emergency use of Pfizer-BioNTech vaccine for children in 12-15 age group

Washington [US], May 11 : The US Food and Drug Administration (FDA) on Monday (local time) authorised the emergency use of the Pfizer-BioNTech COVID-19 vaccine to children in the age group of 12-15 years.
Amending the Emergency Use Approval (EUA) issued on December 11, 2020, for administration in individuals above the age of 16, FDA Commissioner Janet Woodcock said: "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."
"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," she added.
The FDA has determined that Pfizer-BioNTech COVID-19 vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine's use in this population, the body said in a statement.
It noted that children and adolescents generally have a milder COVID-19 disease course as compared to adults.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said: "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."
"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," he further said.
The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain, according to the statement.
However, it was warned that the Pfizer-BioNTech COVID-19 vaccine should not be given to anyone with a known history of a severe allergic reaction, including anaphylaxis.
"The immune response to the vaccine in 190 participants, 12 through 15 years of age, was compared to the immune response of 170 participants, 16 through 25 years of age. In this analysis, the immune response of adolescents was non-inferior to (at least as good as) the immune response of the older participants," the FDA noted.
Since December last year, companies have delivered more than 170 million doses of the vaccine across the US.
The Pfizer-BioNTech vaccine was also determined to be more than 91 percent effective in preventing symptomatic COVID-19 at least six months after the second dose.