US FDA authorizes Pfizer for kids aged 5-11

Washington: The US Food and Drug Administration (FDA) has authorized the emergency use of the Pfizer-BioNTech Covid-19 vaccine in children between five to 11 years, the first jab against the virus for kids in this age group.

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 favour of making the vaccine available to children in this age group, the agency said in a statement late Friday.

The Pfizer-BioNTech vaccine is administered as a two-dose primary series, three weeks apart, but is a lower dose (10 mg) than that used for individuals 12 years of age and older (30 mg), reports Xinhua news agency.

The decision came following an FDA advisors’ meeting held earlier this week which recommended authorizing the vaccine.

The advisors believed the benefits of the jab outweigh its risks for use in this younger group. Data show immune responses of children aged five to 11 were comparable to those of individuals between 16 to 25 years. In that study, the vaccine was 90.7 per cent effective in preventing Covid, according to the FDA.

The vaccine’s safety was studied in approximately 3,100 children in the age group who received the vaccine and no serious side effects have been detected in the ongoing study, said the FDA. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.

“Vaccinating younger children against Covid-19 will bring us closer to returning to a sense of normalcy,” said Acting FDA Commissioner Janet Woodcock.

“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,” she said.

Covid-19 cases in children in the five to 11 age group make up 39 per cent of infections in individuals younger than 18 years of age, according to the CDC. Approximately 8,300 cases have resulted in hospitalization.

At least 691 deaths have been reported in the US in individuals less than 18 years of age, with 146 in the five to 11 group.