The Pfizer and Moderna Covid-19 vaccines are now authorized for children as young as 6 months old, an FDA decision that clears the way for this last remaining age group to gain access to either of the shots. These messenger RNA vaccines are expected to become available to young children as soon as early next week.
The FDA has amended the emergency authorization of the Moderna vaccine to cover those 6 months through 17 years old, expanding beyond the previously authorized use of the shot in adults 18 and older. The vaccine co-developed by Pfizer and BioNTech is already approved for those 16 and older and authorized for children 5 and older. The FDA’s latest move expanded the authorized use of this vaccine to include children 6 months through 4 years of age.
The changes announced Friday for both vaccines come two days after an advisory committee to the FDA held separate votes on each of them, unanimously voting to recommend authorizations for both. Speaking during a Friday morning news conference, FDA Commissioner Robert Califf said that while there are nuanced differences between the two vaccines, should feel comfortable with whichever vaccine is available to them through their pediatrician or pharmacy.
“I’ve got two grandchildren in the age category,” he said. “They’ll get the first one that’s available.”
The pediatric Covid-19 vaccines are just like the mRNA vaccines developed for adults, but at a lower dose. In children 6 months through age 4, the Pfizer/BioNTech vaccine is three shots: the first two given three weeks apart, followed by a third dose at least eight weeks after the second dose. Pediatric dosing for Moderna’s Covid-19 vaccine follows the same schedule as adults: two shots given four weeks apart. For immunocompromised patients in this younger age group, a third dose is authorized at least four weeks after the second dose of the initial two-shot regimen.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In its announcement of the amended authorizations, the FDA noted that its decision for the Moderna vaccine was based on data from two clinical trials that showed the immune responses in children were comparable to the immune responses in tests of the vaccine in adults. An analysis was conducted in about 5,400 children at least 14 days following the second dose during the time when the omicron variant was the dominant circulating strain. The FDA said that in those 6 months through 23 months of age, the vaccine was 50.6% effective in preventing Covid-19. In the 2 through 5 years of age group, the vaccine was 36.8% effective in preventing Covid infection.
The FDA did not provide a similar analysis for the Pfizer/BioNTech vaccine in children. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that the Pfizer data are publicly available. He added that the agency did not provide similar analysis of the Pfizer/BioNTech vaccine because those data are not as mature as the Moderna data. But he said the lack of analysis is not due to any concerns about the Pfizer/BioNTech vaccine, and that both pediatric vaccines met safety and efficacy benchmarks.
The monitoring of the mRNA vaccines since they’ve reached the market has identified two safety risks to the heart. Myocarditis, which is an inflammation of the heart muscle, and pericarditis, which is an inflammation of the tissue surrounding the heart, have been reported for both vaccines. The FDA said that for the Moderna vaccine, the observed risk is highest in males 18 through 24. For the Pfizer/BioNTech vaccine, that risks is highest in males age 12 through 17.
The FDA said that its analysis as well as that of the Centers for Disease Control and Prevention found that most of the myocarditis cases resolved quickly with conservative management of symptoms. In most patients contacted for follow-up 90 days or later after the initial myocarditis report, the FDA said that the vaccines did not impair quality of life. The companies have submitted plans to the FDA to continue monitoring any heart risks tied to the vaccines; longer-term follow-up of children in clinical trials is ongoing.
The next step for the vaccines is to receive a recommendation from the CDC’s Advisory Committee on Immunization Practices. This body is meeting to discuss the pediatric vaccines Friday and Saturday. A vote on recommending their use in children is scheduled for Saturday. Marks said that if the committee votes to recommend these vaccines, they could become available for distribution early next week.
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