Food and Drug Administration regulators Friday released their evaluation of data from the Pfizer-BioNTech submission for emergency authorisation of a lower-dose vaccine for young children. An advisory panel to the FDA will consider Pfizer’s application for those ages 5 to 11 on Tuesday. Children 12 and older have been eligible for vaccination since May.
Pfizer’s data looks “good as to the efficacy and safety,” Fauci said on ABC’s news programme “This Week,” which aired Sunday.
According to Pfizer and BioNTech, the children who were vaccinated as part of the trial, who received doses that were one-third the size of the adult doses, developed robust immune responses after receiving the regimen of two shots three weeks apart. The companies have said the efficacy rate of the vaccine in children reduced the risk of developing a symptomatic infection by 91%.
The most-common side effects in children were fatigue, headache, muscle pain and chills. According to the FDA, the data submitted indicated no cases of myocarditis inflammation of the heart muscle, or pericarditis, inflammation of the outer lining of the heart, rare complications that have been reported among young boys and men receiving the vaccine in other trials and in real-world applications.
Dr Rochelle Walensky, director of the Centres for Disease Control and Prevention, was also interviewed about the upcoming decisions on child vaccines on two Sunday news shows and seemed to promise that decisions would not be delayed. “We know how many parents are interested in getting their children vaccinated, and we intend to work as quickly as you can,” Walensky said on “Fox News Sunday."
Boosters of all three vaccines available in the United States have been authorised. Additional shots of Pfizer and Moderna mRNA vaccines have been approved for people ages 65 and older, those with underlying health conditions and all adults whose living or working conditions place them at high risk of exposure to the virus. Anyone over the age of 18 who received the single-dose Johnson & Johnson vaccine at least two months ago is also eligible for a booster shot.
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