Pfizer asked the FDA to authorize its COVID-19 vaccine for children ages 5 to 11

The US drug regulator promised to quickly evaluate the request and scheduled a meeting on October 26 to consider it.

Pharmaceutical companies Pfizer and BioNTech asked US regulators to authorize the emergency use of their coronavirus vaccine for children ages 5 to 11 , a measure that could help protect more than 28 million people in the United States.

The companies announced Thursday that they were submitting data supporting the change to the Food and Drug Administration (FDA) . The agency has promised to act quickly on the request and has tentatively scheduled a meeting on October 26 to consider it.

Approval depends not only on the strength of the clinical trial data , but on whether they can demonstrate to regulators that they can adequately manufacture a new pediatric formulation.

Acting FDA Commissioner Janet Woodcock said last week that children may require “a different dosage or formulation than is used in an older pediatric population or in adults.”

The vaccine manufactured by Pfizer and its German partner BioNTech  is now available for those 12 years and older . But now that children have returned to school in the US and the most contagious delta variant is causing a large increase in pediatric infections, many parents are eagerly awaiting vaccinations for their youngest children.

For school-age children,  Pfizer tested a much lower dose, one-third the amount now given in each vaccine. The company said in September that the vaccine was safe for children ages 5 to 11.

At the time, Pfizer said it had studied the lowest dose in 2,268 preschool and elementary school children . The FDA required what is called an immune “bridge” study – evidence that younger children developed levels of antibodies that have already been shown to be protective in adolescents and adults.

After their second dose,  children ages 5 to 11 developed levels of antibodies to the coronavirus as strong as adolescents and young adults , Dr. Bill Gruber , Pfizer senior vice president and pediatrician, told Globe Live Media.

The children’s dose has also been  shown to be safe, with similar or minor temporary side effects – such as arm pain, fever or malaise – to those experienced by teens, he said.

Until now, many Western countries have not vaccinated children under 12 years of age , waiting to be shown what the appropriate dose is and if it works safely in the little ones. However, in September Cuba began vaccinating children up to 2 years of age with its own vaccines , and the Chinese authorities have authorized two of its brands up to 3 years.

Although children are at less risk of becoming seriously ill or dying than older adults,  more than 5 million children in the United States have tested positive for COVID-19 since the pandemic began and at least 460 have died , according to the American Academy. of Pediatrics. Cases in children have increased dramatically as the delta variant spread across the country.

A second US vaccine maker, Moderna, is also studying its vaccines in school-age children. Pfizer and Moderna are also studying younger children, up to 6 months . Results are expected by the end of the year.