Moderna’s coronavirus vaccine for youngsters under 6 is effective in stopping symptomatic infection without causing worrisome unwanted side effects, the Food and Drug Administration said on Friday night.
Advisers to the F.D.A. are scheduled to fulfill next week to make your mind up whether to recommend that the agency grant Moderna’s request for emergency authorization of its vaccine for youngsters ages 6 months to 17 years. They may even consider an application from Pfizer and its German partner, BioNTech, to clear its pediatric vaccine for youngsters under 5. The F.D.A. is predicted to release its evaluation of Pfizer’s application on Monday.
The F.D.A. cautioned that estimates of the efficacy of Moderna’s two-dose pediatric vaccine were based on relatively few cases of Covid-19. The agency also said that, like adults, pediatric recipients would probably require a booster shot to counteract the vaccine’s waning potency over time.
However the agency said that two shots of Moderna’s vaccine triggered an immune response in clinical trial participants comparable to that of young adults, meeting the criterion set for effectiveness. The outcomes were measured by the extent of neutralizing antibodies, which work to dam the virus, in the youngsters’s blood.
Children 11 and younger generally experienced fewer unwanted side effects from the vaccine than adolescents, probably because their doses were weaker, the F.D.A. said. Although fevers were more frequent in children under 6, the rates weren’t substantially different from those produced by other routine childhood vaccines, the agency said.
There have been no cases of myocarditis or pericarditis, conditions involving inflammation of the center muscle and surrounding tissue which might be known risks for young men who receive Moderna or Pfizer coronavirus vaccines.
The roughly 18 million children under 5 are the one group in america not eligible for Covid shots. Those 5 or over are covered by the Pfizer-BioNTech vaccine.
Moderna and Pfizer are proposing different regimens to cover the youngest children. Pfizer is in search of authorization for a three-dose regimen with doses one-tenth the strength of adult shots. Moderna has proposed two doses at one-quarter the strength of adult doses.
Moderna’s vaccine was 51 percent effective in stopping symptomatic infection in children 6 months to 2 years old and 37 percent effective in children 2 to five years old. Pfizer said its clinical trial suggested that its vaccine was 80 percent effective, however the trial was based on 10 cases. Greater than twice that number is required to evaluate the efficacy of the shots.
Anticipating regulatory authorization of 1 or each vaccines, the White House outlined this week its initial plan to make shots available for youngsters under 5, starting the week of June 19. Biden administration officials said that the federal government had made 10 million doses available to states and health providers.