“The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group,” the agency said on Friday.
Earlier this week, the FDA’s vaccines advisory committee voted 17-0, with one abstention, to approve the emergency use of the vaccine for children. The jabs would be administered three weeks apart, in two 10-microgram doses – a third of the dose currently recommended for everyone 12 and older.
The panel’s decision was based on data presented by Pfizer, which tracked 2,268 children in the 5-11 age group who received either the recommended regimen or a placebo. Only three of the vaccinated developed symptomatic Covid-19 compared to 16 in the placebo group, according to the study conducted in August and September.
“Vaccinating younger children against [Covid]-19 will bring us closer to returning to a sense of normalcy,” said acting FDA Commissioner Janet Woodcock in a statement on Friday.
“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency was “committed to making decisions that are guided by science that the public and healthcare community can trust.”
“We are confident in the safety, effectiveness and manufacturing data behind this authorization,” he added.
Addressing concerns over myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following the Pfizer-BioNTech vaccine use in males between 12 -17 years of age, the FDA said it conducted “its own benefit-risk assessment using modelling” to see how many deaths might be caused by the vaccine versus Covid-19. Its model “predicts that overall, the benefits of the vaccine would outweigh its risks in children 5 through 11,” the FDA said.
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