New York: The United States Food and Drug Administration (FDA) on Friday authorised the use of Pfizer-BioNTech’s COVID-19 vaccine for children in the age group of 5 to 11 years. The US Centres for Disease Control and Prevention (CDC) has scheduled an advisory committee meeting to review the pediatric doses next week.
The FDA said in a statement that the decision was based on the food and drug administration’s “thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favour of making the vaccine available to children in this age group,” as per CNBC.
The FDA further noted the immune responses of children between the age of 5 and 11 were compared with those of individuals 16 through 25 years of age. The Pfizer-BioNTech shots have shown 90.7% efficacy in preventing COVID-19 in children aged 5-11. The Food and Drug Administration said that it studied the vaccine safety in approximately 3,100 children among the same age group of 5 to 11 “and no serious side effects have been detected in the ongoing study.”
Acting FDA Commissioner Janet Woodcock said in a statement, “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. 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.”
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