Pfizer Vaccine Effective in Children Under 5, the FDA Says

The Food and Drug Administration said on Sunday that three doses of the Pfizer-BioNTech coronavirus vaccine appeared to be effective in preventing Covid disease in children under 5, judging by the level of virus-blocking antibodies that induced the shots.

The agency’s evaluation was posted online ahead of Wednesday’s meeting with outside vaccine experts, summarizing how the FDA should rule on applications from both Pfizer and Moderna vaccinating the nation’s youngest children.

Some public health experts are expecting the FDA to authorize both Moderna’s and Pfizer’s vaccines, offering parents a choice between the two. The Centers for Disease Control and Prevention must also weigh in with its recommendations after the FDA acts. Roughly 18 million children younger than 5 are the only Americans who are not yet eligible for shots.

In a staff analysis, the FDA said the data submitted by Pfizer and its German partner, BioNTech, suggests that three doses are more effective than two. But the agency said it was difficult to draw definitive conclusions because there were so few cases of Covid among 1,415 children who received three doses of the vaccine during the clinical trial.

Pfizer said only eight children in the placebo group and two in the vaccinated group fell ill. The trial protocol said 21 cases were required to render a decision on efficacy.

So far, the FDA appears to see both Pfizer’s and Moderna’s requests for pediatric vaccines favorably. Parents are so eager to have a coronavirus vaccine for their youngest children that some said they would accept even lower rates of effectiveness, as long as the vaccines were safe.

In its analysis of Pfizer’s data, the agency said the rates of hospitalization and death caused Covid among children under 5 to be higher among those ages 5 to 17, “underscoring the benefit of an effective Covid-19 vaccine in this age group.”

The agency also noted that among children 5 or older, who are already eligible for Pfizer’s vaccine, the shots have helped prevent hospitalization and other serious consequences, including the current year, when the highly contagious Omicron variant and its rapidly evolving subvariants became dominant. forms of the virus.

“Given the uncertainty of the Covid-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of vaccine use among children 6 months through 4 years of age will have a beneficial effect 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 Moderna’s coronavirus vaccine for children under 6 was also effective in preventing symptomatic infections without causing worrisome side effects. The two vaccines are based on the same type of technology, but the dosage and regimens are different. Moderna is proposing two doses at one-quarter the strength of adult doses. Pfizer is proposing three doses at one-third the strength of adult shots.

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