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.
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.
Source: IANS
