But outside experts said they would be surprised to see the FDA take such a stance. “There is some discretion there, but if you have something, you’ve reviewed it and it’s meeting an unmet medical need, you’re going to want to get it out there when you can,” Dr. Jesse L. Goodman, a former chief scientist for the agency, said.
Dr. Paul Burton, Moderna’s chief medical officer, said in an interview Wednesday that “the data that we have now, that will go in today, should be sufficient for FDA to begin the review.” He said he hoped that the agency would “carefully and appropriately assess the data and not hold it up,” adding: “They’ll do the right thing. They always have.”
Moderna’s clinical trial data showed that the antibody response of the youngest children compared favorably with that of adults ages 18 to 25, meeting the trial’s primary criterion for success. Although the trial was not big enough to measure vaccine effectiveness, Moderna said Thursday the vaccine appeared to be 51 percent effective against symptomatic infection among those younger than 2, and 37 percent effective among those 2 to 5.
Those results were slightly better than the ones Moderna previously released for children under 2. The company said that was because the second time, the firm excluded infections that had not been confirmed with a PCR test analyzed in a laboratory. Dr. Burton said the new results came from a more rigorous analysis, but did not differ significantly from the earlier ones. He said the Omicron variant accounted for about 80 percent of infections in the study group. Side effects were at a similar level as those from previously approved pediatric vaccines, with fevers in 15 percent to 17 percent of the children, Moderna said.
Omicron has scrambled the calculus for evaluating vaccines because it has proved far more adept than previous versions of the virus at evading the vaccines’ shield against infection, although their protection remains strong against severe illness and death. Both Moderna and Pfizer found that compared with earlier trials, their vaccines’ effectiveness against infection plunged in clinical trials for young children, which were carried out largely during the winter Omicron surge. There is no agreed-upon standard for what would constitute a successful Covid vaccine for young children.
Even while it limited the vaccines’ protection, Omicron helped build up the nation’s immunity. As of February, 60 percent of Americans, including 75 percent of children, had been infected with the coronavirus at some point, according to research released this week by the Centers for Disease Control and Prevention. In December 2021, as the Omicron variant began spreading, only half as many people had antibodies indicating prior infection, the agency said.
Dr. Sean O’Leary, an infectious disease specialist at Children’s Hospital Colorado, said the CDC’s findings did not lessen the need to vaccinate young children. “A lot of kids have been infected,” he said, but “there is certainly additional benefit of getting vaccinated.” He added: “I also recognize that it’s a complex situation” for the FDA
The fact that the pandemic is in a relative lull may give the agency a little breathing room. For those 17 and under, the rate of new hospital admissions is one-eighth of what it was in January, when it hit a high. Daily admissions now number fewer than 120 children, out of about 73 million nationwide, according to the CDC