WASHINGTON — The long-awaited approval for coronavirus immunizations for children under 5 took a major step forward on Monday with an announcement from biomedical giant Pfizer and its German partner, BioNTech, that their COVID-19 vaccine “was found to elicit a strong immune response,” with no significant adverse reactions.
“Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” Pfizer chief executive Albert Bourla said in a statement.
Moderna had submitted similar data to the Food and Drug Administration late last month, but the agency wanted to wait until Pfizer’s submission before granting emergency authorization for the under-5 cohort, prolonging a delay that had frustrated lawmakers and parents alike.
With the Pfizer results having been announced, approval seems imminent. Pfizer’s clinical trials involved 1,678 children between 6 months and 5 years who were administered three doses of coronavirus vaccine that, like Moderna’s, uses messenger RNA, or mRNA, technology. The doses were 3 micrograms each, much smaller than the two-dose vaccines for older children (10 micrograms) and adults (30 micrograms).
Children between the ages of 5 and 11 were approved for booster shots earlier this month.
The vaccination proved 80.3% effective against the Omicron variant, which was the prevalent strain of the coronavirus at the time the trials were conducted, earlier this year. Pfizer said there were 10 “symptomatic” cases recorded among the children participating in the trial a week after the third dose and that the “majority of adverse events were mild or moderate.”
In February, Pfizer said it was waiting to submit its application to the FDA until data on a third vaccine dose was available. The delay dismayed parents who had to contend with unvaccinated young children as the rest of society increasingly returned to normal.
“Many parents of young children feel left behind,” Colorado Gov. Jared Polis wrote to President Biden in April, urging the FDA to act more quickly.
How are vaccination rates affecting the latest COVID surge? Check out this explainer from Yahoo Immersive to find out.