MANILA, Philippines — Pfizer-BioNTech announced on Monday that their COVID-19 vaccine is safe for children between ages 5 and 11. Data from clinical trials showed that its mRNA shot generated a robust antibody response among participants.
The highly anticipated announcement came from late-stage clinical trials. The trial included 2,268 participants, from ages 5 to 11. The two shot vaccine was administered 21 days apart. This trial used a 10-microgram dose, much smaller than the usual 30-microgram dosage.
“The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.”
Pfizer-BioNTech
Despite the lower dosage, the trial still yielded ideal results. Data presented from the study showed that the level of neutralizing antibodies among 5-to-11 year-olds were similar to those of observed among 16-to-25 year-olds.
As its next step, Pfizer-BioNTech will need to apply for emergency use authorization with the US Food and Drug Administration. It will also seek to file and EUA in the European Union.
Once the application for authorization has been submitted, the agency would review data for a vaccine for younger children as quickly as possible, likely in a matter of weeks rather than months. However, we don’t want children to have adverse effects. Granted, we want them to be able to get vaccinated as quickly as possible, but let’s do it right.”
Dr. Peter Marks, director of FDA’s Center for Biologics Research and Evaluation
FDA Commissioner Dr. Janet Woodcock mentioned that the agency would earnestly review data for a vaccine for younger children.