FDA authorizes use of Pfizer vaccine for children aged 12-15
pharmafile | May 11, 2021 | News story | Manufacturing and Production | COVID-19, FDA, Pfizer, Vaccine
The FDA announced it has expanded the emergency use of the Pfizer-BioNTech vaccine in children aged 12-15 yesterday.
It was determined after a trial of more than 2,260 volunteers in the US aged between 12 and 15 that the vaccine met the statutory criteria and that the known and potential benefits of this vaccine in this age group outweigh the known and potential risks.
The original Emergency Use Authorization (EUA), issued in December for the Pfizer-BioNTech vaccine, has now been amended to cover the vaccine administration of children aged from 12 to 15.
Between March 2020 and April 2021 the US recorded approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age.
Acting FDA Commissioner Janet Woodcock said: “The FDA’s expansion of the EUA 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 EUAs.”
This news comes less than a week after Canada announced it would offer the Pfizer-BioNTech vaccine to those over 12 years old.
Many other countries are using the vaccine on people aged 16 and older.
Director of the FDA’s Center for Biologics Evaluation and Research Peter Marks said: “Having a vaccine authorized 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.”
Around 46% of people in the US have received at least one dose of a COVID-19 vaccine but the pace has slowed in recent weeks.
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