Pfizer-BioNTech seek FDA approval for its COVID-19 vaccine for children

Amid fears of a third wave that apparently may affect children more, the COVID-19 vaccine for the age group of 5 to 11 years may soon hit the market. Pfizer and its German partner BioNTech have urged the Food and Drug Administration (FDA) to authorise its COVID-19 vaccine for children.

Reports suggest that if the US regulator gives its nod then within weeks the COVID-19 vaccine could be administered to children in the United States. The agency has promised to move quickly on the request and has tentatively scheduled a meeting on October 26 to consider it. Pfizer has claimed that there were no serious side effects found during testing on volunteers.

However, clearance by FDA depends not only on the clinical trial data but also on whether they can prove to regulators that they are able to properly manufacture a new pediatric formulation.

Pfizer and BioNTech claim that their research showed younger children should get just one-third of the dose given to the elderly population. Their research suggests that after giving the second dose of the COVID-19 vaccine, 5-11-year-olds developed virus-fighting antibody levels just as strong as fully vaccinated adults. 

If the FDA authorises emergency use of the COVID-19 vaccine, the Centres for Disease Control and Prevention will take a final decision in this regard after consultation with advisors. The company has also planned that to avoid any mix-ups, the lower-dose vials will be specially marked for use in children.

Meanwhile, Moderna has also requested Food and Drug Administration (FDA) to give permission to use its vaccine in  12 to 17 years old teens.