Pfizer announced Monday that a Phase 2/3 trial of its Covid-19 vaccine showed it was safe and produced a strong antibody response in children aged 5-11.
These are the first results for the age group of US Covid-19 vaccines. The data have not been peer-reviewed and published. Pfizer stated that it will soon submit data to the US Food and Drug Administration to obtain emergency use authorization.
2,268 children aged 5-11 participated in the trial. The vaccine was administered in two doses, each 21 days apart. The 10-microgram dose was used in these trials, which is smaller than the 30-microgram dose used for 12 and older.
“The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer said in a news release.
The immune response of participants was measured by measuring the levels of neutralizing antibodies in their blood. These levels were compared to levels in a control group consisting of 16- to 24-year-olds given a 30-microgram dose and then given a double-dose regimen.
Pfizer stated that the levels were comparable to older patients who had received the higher dose. This indicated that there was a strong immune response in the cohort of children one month after receiving the second dose.
“Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age,” the company said.
A spokesperson for Pfizer also confirmed that there were no cases of myocarditis. This is a form of inflammation of the heart that has been linked to mRNA vaccines.
Pfizer stated that these data would be included in a “near term submission” for EUA. The companies will continue to collect the data required to file for FDA approval of people aged 5-11 years old.
Pfizer/BioNTech is already approved for adults aged 16 and over. It is also authorized for children 12 and under.
Pfizer said it is expecting trial data for children as young as 6 months “as soon as the fourth quarter of this year.”
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. 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,” Albert Bourla, chairman and chief executive officer of Pfizer, said in the statement.
Scott Gottlieb, an ex-FDA commissioner and current member of the Pfizer board, said that a vaccine for children aged 5-11 years old could be available by Halloween. Dr Janet Woodcock, acting FDA commissioner, and Dr Peter Marks (director of FDA’s Center for Biologics Research and Evaluation), stated in a statement that they would review data for vaccines for children younger than 11 years old “as fast as possible” once the application was approved.
“However, the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers,” they wrote.
As cases have risen among children, calls for Covid-19 vaccines for children younger than 5 years old have increased.
According to the American Academy of Pediatrics, Coronavirus infections are now “exponentially” increasing in children across the United States. They account for almost 29% of all reported cases nationwide.
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