WASHINGTON — The long-awaited approval for coronavirus immunizations for children under the age of 5 took a big step forward Monday with the announcement by biomedical giant Pfizer and its German partner, BioNTech, that their COVID-19 vaccine “elicited a strong immune response.” without significant side effects.
“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 as one-tenth the dose strength for adults, had well tolerated and strong immune response,” Pfizer CEO Albert Bourla said in a statement:†
Moderna had submitted similar data to the Food and Drug Administration end of last monthbut the desk wanted to wait for Pfizer’s submission before an emergency consent was granted to the cohort under 5, extending a delay that had frustrated lawmakers and parents alike.
With Pfizer’s results announced, approval appears imminent. Pfizer’s clinical trials involved 1,678 children between the ages of 6 months and 5 years who received three doses of a coronavirus vaccine that, like Moderna, 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 from 5 to 11 years were approved for booster shots earlier this month†
The vaccination was found to be 80.3% effective against the Omicron variant, the most common strain of the coronavirus at the time the trials were conducted, earlier this year. Pfizer said that one week after the third dose, 10 “symptomatic” cases were registered in the children enrolled in the study, and that the “majority of adverse reactions were mild or moderate.”
In February, Pfizer said it was waiting to file its filing with the FDA? until data on a third vaccine dose became available. The delay caused bewilderment to parents dealing with unvaccinated young children as the rest of society grew more normal.
“Many parents of young children feel abandoned” Colorado Governor Jared Polis wrote: to President Biden in April, urging the FDA to act more quickly.