US FDA clears Pfizer's COVID vaccine for kids aged 5 to 11; CDC to discuss authorisation

The United States Food and Drug Administration (FDA) on Friday, 29 October authorised the use of Pfizer-BioNTech’s COVID-19 vaccine for children ages 5 to 11. To make the shots finally available to 28 million kids in the country, FDA’s nod should be followed by the US Centres for Disease Control and Prevention (CDC) to sign off. The CDC has scheduled an advisory committee meeting to review the pediatric doses next week.

As per CNBC, the advisory panel is expected to swiftly clear the doses for public distribution immediately after the CDC review meeting. 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.”

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.”

‘I know parents have been waiting’

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.”

Presently, the full-strength Pfizer-BioNTech shots are recommended for everyone at the age of 12 and above. But, both parents and paediatricians are reportedly seeking protection for younger children. FDA’s advisory panel endorsing Pfizer shots for children aged 5-11 came after Moderna on Monday stated that a “robust neutralising antibody response” is generated by its COVID-19 vaccine in children between the ages 6 and 11. Following the phase 2-3 trials, the company said that it would soon submit the data to global regulators.

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