Pfizer and Moderna Covid-19 vaccines now available authorized to children At just 6 months old, an FDA decision cleared the way for this last remaining age group to get any vaccine. These messenger RNA vaccines are expected to be available to young children as early as next week.
The FDA has revised the emergency authorization for Moderna’s vaccine to cover people 6 months to 17 years of age, beyond the previous authorization for the vaccine’s use in adults 18 and older. The vaccine co-developed by Pfizer and BioNTech is approved for use in people 16 years of age and older and licensed for use in children 5 years of age and older. The FDA’s latest move expands the vaccine’s authorized use to children 6 months to 4 years old.
The changes to the two vaccines announced Friday came two days after an FDA advisory committee voted on each vaccine individually, which voted unanimously to recommend authorization for both. FDA Commissioner Robert Califf said in a Friday morning news conference that while there are subtle differences between the two vaccines, they should be comfortable with any vaccine offered through a pediatrician or pharmacy.
“I have two grandchildren at this age,” he said. “They’ll get the first one available.”
Pediatric Covid-19 vaccines are like mRNA vaccines developed for adults, but in lower doses. In children 6 months to 4 years old, the Pfizer/BioNTech vaccine is given in three doses: the first two doses are given three weeks apart, and then the third dose is given at least eight weeks after the second dose. Pediatric doses of Moderna’s Covid-19 vaccine follow the same schedule as adults: two injections four weeks apart. In this younger immunocompromised patient, a third dose is authorized at least 4 weeks after the second dose of the initial two-injection regimen.
In its revised authorization announcement, the FDA noted that its decision on Moderna’s vaccine was based on data from two clinical trials that showed immune responses in children were comparable to those in vaccine testing in adults. About 5,400 children were analyzed at least 14 days after the second dose during a period when the omicron variant was the predominant circulating strain. In infants aged 6 months to 23 months, the vaccine was 50.6 percent effective in preventing Covid-19, the FDA said. In the 2 to 5-year-old age group, the vaccine was 36.8% effective in preventing Covid infection.
The FDA did not conduct a similar analysis of the Pfizer/BioNTech children’s vaccine. Pfizer’s data is public, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He added that the agency did not provide a similar analysis of the Pfizer/BioNTech vaccine because the data are not as mature as the Moderna data. But he said the lack of analysis was not due to any concerns about the Pfizer/BioNTech vaccine, and that both pediatric vaccines met safety and efficacy benchmarks.
Since mRNA vaccines became available, monitoring of them has identified two safety risks to the heart. Myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the tissue surrounding the heart, have been reported with both vaccines. For the Moderna vaccine, the observed risk was highest in men between the ages of 18 and 24, the FDA said. For the Pfizer/BioNTech vaccine, this risk was highest among men aged 12 to 17.
The FDA said its analysis, and that of the Centers for Disease Control and Prevention, found that most cases of myocarditis resolve quickly with conservative management of symptoms. In the majority of patients who were contacted for follow-up 90 days or later after the initial report of myocarditis, the FDA said the vaccine did not impair quality of life. The companies have submitted plans to the FDA to continue monitoring any cardiac risks associated with the vaccine; long-term follow-up of children in clinical trials is ongoing.
The next step for a vaccine is to take the advice of the CDC’s Advisory Committee on Immunization Practices.This body is in a meeting Discuss Pediatric Vaccines Friday and Saturday. A vote on their use among children is scheduled for Saturday. If the committee votes to recommend the vaccines, they could begin distribution early next week, Marks said.
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