The Food and Drug Administration said Sunday that three doses of the Pfizer-BioNTech coronavirus vaccine appeared to be effective in preventing Covid disease in children under 5 years old, judging by the level of virus-blocking antibodies the injections produced.
The agency’s evaluation was posted online ahead of Wednesday’s meeting with outside vaccine experts, who were called upon to recommend how the FDA should decide on applications from both Pfizer and Moderna to vaccinate the nation’s youngest children.
Some public health experts expect the FDA to approve both Moderna and Pfizer’s vaccines, giving parents a choice between the two. The Centers for Disease Control and Prevention should also consider their recommendations after the FDA acts. About 18 million children under the age of 5 are the only Americans not yet eligible for injections.
In a personnel analysis, the FDA said data submitted by Pfizer and its German partner BioNTech suggest that three doses are more effective than two. But the agency said it was difficult to draw firm conclusions because there were so few cases of Covid among the 1,415 children who received three doses of the vaccine during the clinical trial.
Pfizer has said that only eight children in the placebo group and two in the vaccinated group became sick. The study protocol said 21 cases were needed to make a judgment about efficacy.
So far, the FDA appears to favorably consider both Pfizer and Moderna’s requests for pediatric vaccines. Parents are so eager to have a coronavirus vaccine for their youngest children that some have said they would accept even low effectiveness, as long as the vaccines were safe.
In its analysis of Pfizer’s data, the agency said the number of hospitalizations and deaths from Covid in children under 5 was higher than in children aged 5 to 17, “decreasing the benefit of an effective Covid-19 vaccine.” in this age group.”
The agency also noted that in children 5 years or older, who are already eligible for Pfizer’s vaccine, the injections have helped prevent hospitalization and other serious consequences, including in the current year, when the highly contagious Omicron vaccine variant and its rapidly evolving subvariants became the dominant ones. forms of the virus.
“Given the uncertainty of the Covid-19 pandemic and the likelihood of continued transmission of SARS-CoV-2 during subsequent months, the deployment of the vaccine for use in children aged 6 months to 4 years is likely to have a beneficial effect have on Covid-19. associated morbidity and mortality in this age group,” the FDA said. The agency identified minimal side effects.
On Friday, the FDA said that Moderna’s coronavirus vaccine for children under 6 was also effective at preventing symptomatic infection without causing worrisome side effects. The two vaccines are based on the same type of technology, but the dosage and regimens differ. Moderna suggests two doses at a quarter of the strength of adult doses. Pfizer suggests three doses with one-tenth the strength of adult injections.