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• With this approval, the shots will be available to nearly 28 million kids
• The vaccine shot’s dosage is one-third of that given to adults
The FDA authorized the use of Pfizer Inc(PFE)and BioNTech’s COVID-19 vaccine for children aged between 5 and 11, on Friday, making the vaccine shots available to nearly 28 million children.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” acting FDA Commissioner Dr. Janet Woodcock said in a statement.
Pfizer’s vaccine shot for kids contains a third of the dosage given to adults. The company said that the shot is more than 90% effective in preventing asymptomatic infection. It also said the shots were well tolerated in young children, producing side effects comparable with those seen in a study of people ages 16 to 25.
The expected FDA clearance came after the agency’s Vaccines and Related Biological Products Advisory Committee voted on Tuesday in favor of a smaller dose of the Pfizer vaccine for young children.
On October 26, the FDA held a panel meet with outside advisers to discuss amending its Emergency Use Authorization (EUA) to make the two-dose Pfizer/BioNTech available for the 5-11 age group.
With the delta variant spreading and schools reopening for the new academic session, parents are getting anxious to get their children vaccinated.
The FDA stated that as of October 17, 691 deaths from COVID-19 have been reported in the U.S. in people under 18 years of age. Out of those, 146 deaths have been reported among the 5 to 11 years age group.