The first COVID-19 vaccine trial for children aged 5-11 has returned promisingly strong results, bringing parents one step closer to immunization against the coronavirus for the younger members of the family. The new data suggests Pfizer-BioNTech’s mRNA vaccine, branded Comirnaty, “showed robust neutralizing antibody responses” to COVID-19.
Currently, Comirnaty is approved by the FDA for use in individuals aged 16 years or above. The FDA’s existing emergency use authorization (EUA) remains in place, meanwhile, for administration of the vaccine to those aged 12 through 15 years of age.
However that still left a sizable cohort of people younger than 12 unvaccinated, with Pfizer and BioNTech running clinical trials to see how safe and effective the drug would be. The Phase 2/3 trial looked at 2,268 participants aged between 5 and 11 years. They received a two-dose Comirnaty regimen.
The dose itself was lower, however, at 10 micrograms versus the 30 microgram amount in each injection for those 12 years and older. The two shots were given 21 days apart.
“The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses,” Pfizer reported today. “The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age.”
The vaccine was well tolerated, the pharma companies add, “with side effects generally comparable to those observed in participants 16 to 25 years of age.” That typically includes some soreness at the point of injection, along with brief cold or flu symptoms.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination,” Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said today in a statement. “These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
The hope is that the FDA will further adapt the existing EUA, allowing Comirnaty to be administered under the emergency use protocols to children aged 5-11. At the same time, meanwhile, Pfizer-BioNTech’s ongoing trial includes two other age groups: children 2-5 years old, and children 6 months to 2 years old. They received even smaller doses, of 3 micrograms per injection. The study enrolled children who had no previous evidence of a COVID-19 infection.
Data from those groups is expected as soon as Q4 2021, the companies say, and the results of the whole trial will be submitted for peer-reviewed publication.