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F.D.A. Panel Debates Covid Vaccines for Youngest Kids

External advisers to the Food and Drug Administration will consider applications from Moderna and Pfizer on Wednesday to vaccinate the youngest American children against the coronavirus, a much-anticipated review that could pave the way for regulators to grant emergency approval for one or both vaccines this week. .

The FDA has said the companies’ clinical trial data shows that each vaccine met the criteria for safety and effectiveness in the age group. The agency sent 230 pages of documents to the outside consultants for review. Votes on whether or not to recommend approval of the Pfizer vaccine for children 6 months to 4 years old, and Moderna’s for children 6 months to 5 years old, are expected by the end of Wednesday.

More than two years after the coronavirus pandemic, no vaccine has been approved in the United States for children under the age of 5, an unmet need that has baffled many parents. If the advisory panel recommends one or both vaccines, the FDA is ready to release them as early as Friday.

A similar advisory committee for the Centers for Disease Control and Prevention is scheduled to meet on Friday and Saturday to make its own recommendation, which could lead to children getting vaccinated next week.

Some difficult questions remain. Perhaps most importantly, neither vaccine has been tested against the subvariants now permeating the United States. The clinical trials were largely conducted when the Omicron variant predominated, before the emergence of subvariants. Two of them, BA.4 and BA.5, could become dominant within a month.

“We’re really trying to predict the future,” says Dr. Paul Offit, vaccine expert at Children’s Hospital in Philadelphia and member of the FDA advisory panel. “This is a problem.”

Members of the advisory committee can also elaborate on how the two vaccines differ and whether one is better than the other. Pfizer wants to offer the youngest children its vaccine in three doses with one-tenth the strength of adult injections. Modernas would be two doses at a quarter the strength of adult injections.

Both appear significantly less effective against symptomatic infection than the adult vaccines when they were first rolled out in December 2020. The FDA attributes this to the fact that Omicron is much more adept at evading the vaccines’ defenses against infection than the vaccines. original version of the virus.

Given the declining protection seen in adult recipients and the rapid evolution of the virus, regulators have said that pediatric recipients of Pfizer’s and Moderna’s vaccines will both most likely require a booster dose. That would mean that Pfizer’s vaccine, developed with German company BioNTech, could end up as four doses, while Moderna’s could be three.

Both vaccines produced levels of neutralizing or virus-blocking antibodies in children similar to those seen in teens and young adults ages 16 to 25. Pfizer’s vaccine has been approved for children ages 6 to 17 since last year, and regulators said it helped prevent hospitalization and deaths.

While studies have shown that the adult versions of both vaccines were more than 90 percent effective at preventing Covid when they were first rolled out in December 2020, the variants have weakened their potency.

After two doses, Pfizer’s vaccine was only 28 percent effective at preventing symptomatic infection in children 6 months through 4 years of age. Pfizer suggested the vaccine was 80 percent effective after a third dose, but the finding was based on just 10 cases from a subset of the study’s 1,678 participants. The study protocol specified that vaccine efficacy assessments should be based on at least twice as many cases.

Moderna found that the vaccine was 51 percent effective in preventing symptomatic infection in children 6 months to 2 years old, and 37 percent effective in children 2 through 5. Those results seem consistent with those reported in studies of adults during the Omicron era, the FDA said. Still, immunization continues to provide strong protection against serious illnesses leading to hospitalization and death.

While Moderna’s efficacy data seemed slightly stronger than Pfizer’s, the vaccine also seems to cause more fevers for parents to worry about. But scientists strongly warned against such comparisons.

“These are different populations. The studies were conducted at different times. The results are reported in different ways, with different endpoints,” said Dr. Jesse L. Goodman, a former chief scientist for the FDA. “Scientifically, we don’t have a direct comparison.”

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