All three authorized vaccines — from Moderna, Pfizer and Johnson & Johnson — vastly surpassed that at first. But Omicron’s uncanny ability to dodge the immune system’s defenses is changing the calculus, and so far, no new standard has been set.
The F.D.A. authorized the Pfizer-BioNTech vaccine for those aged 12 to 15 in May after a trial showed zero infections in the vaccine arm and 18 in the placebo group — a ratio Pfizer described as 100 percent efficacy. But in October, when the agency authorized Pfizer’s vaccine for children 5 to 11, it relied solely on immune response data, which showed that the vaccine triggered a powerful surge in antibodies. That was also the criterion set for the trials of younger children.
At the time, given the antibody response, regulators were unwilling to wait for Covid infections to accrue in enough trial participants to gauge efficacy. But because the Omicron variant spread through so much of the population over the winter, both Moderna and Pfizer are now able to gauge efficacy in their youngest trial participants.
Pfizer decided last month to hold off on a request for emergency authorization of two doses after seeing efficacy data from the Omicron surge.
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Moderna is asking for similar authorization, citing efficacy data that is just as weak. On the other hand, Moderna’s two-dose regimen achieved better results than Pfizer’s in boosting the immune systems of young children. Pfizer said in December that after two doses of its vaccine, children aged 6 months to 2 produced antibody levels comparable to those of older teenagers and young adults.
But children ages 2 through 4 produced only 60 percent of the sought-after antibody response. After two doses of Moderna’s vaccine, the antibody response of children in both subsets compared favorably to that of people 18 to 25, meeting the trial’s primary criterion for success.
“I’m heartened by the strong neutralizing antibody response indicating long-lasting cellular immunity,” said Dr. Monica Gandhi, an infectious disease doctor and professor of medicine at the University of California, San Francisco.