The Food and Drug Administration said Friday night that Moderna’s coronavirus vaccine for children under the age of 6 was effective in preventing symptomatic infections without causing annoying side effects.
FDA advisors will meet next week to decide whether to recommend the FDA to grant Moderna’s request for an emergency vaccine permit for children aged 6 months to 17 years. They will also consider an application from Pfizer and its German partner BioNTech to clear a pediatric vaccine for children under the age of five. The FDA will publish an analysis of Pfizer’s application on Monday.
The FDA warned that the estimation of the efficacy of Moderna’s double-dose pediatric vaccine was based on a relatively small number of cases of Covid-19. Authorities also said that, like adults, pediatric recipients would probably need booster shots to counteract the diminishing efficacy of the vaccine over time.
However, the agency said the two shots of Moderna’s vaccine elicited an immune response in clinical trial participants comparable to that of young adults and met the criteria set for efficacy. Results were measured by the level of neutralizing antibodies that acted to block the virus in the child’s blood.
According to the FDA, children under the age of 11 generally had fewer side effects from the vaccine than adolescents. Fever was more frequent in children under 6 years of age, but the rate was not substantially different from that produced by other regular childhood vaccines, officials said.
There were no cases of myocarditis, pericarditis, or a condition with inflammation of the heart muscle or surrounding tissues known to be a risk for young men vaccinated with the Modena or Pfizer coronavirus vaccine.
Approximately 18 million children under the age of 5 are the only group in the United States that is not eligible for Covid Shots. Those over the age of 5 are eligible for the Pfizer BioNTech Vaccine.
Moderna and Pfizer offer different regimens to cover the youngest children. Pfizer seeks approval for a three-dose regimen at one-tenth the dose of adult shots. Moderna proposes two doses with one-fourth the intensity of the adult dose.
The Moderna vaccine was 51% effective in preventing symptomatic infections in children aged 6 months to 2 years and 37% in children aged 2 to 5 years. Pfizer said the clinical trial suggested that the vaccine was 80% effective, but the trial was based on 10 cases. You need more than twice that number to evaluate the effect of a shot.
The White House has outlined its first plans to allow children under the age of five to inject from the week of June 19th this week, hoping for regulatory approval for one or both vaccines. Health care provider.