FDA panel unanimously backs Moderna’s Covid vaccine for children ages 6 to 17

A panel of experts convened by the Food and Drug Administration voted unanimously Tuesday to recommend the agency authorize the Moderna Covid vaccine for children ages 6 to 17.

The authorization would mirror the current emergency use authorization of the Covid vaccine developed by Pfizer and BioNTech, which is authorized for individuals 6 years and older.

“I believe this vote, and I am happy to say it was unanimous, is standing up for vulnerable populations that merit protection against this virus,” said Ofer Levy, a member of the FDA’s expert panel and director of the precision vaccines program at Boston Children’s Hospital. “I believe this will provide families with an important option.”

The FDA does not have to follow the recommendations of its expert committees, but it generally does. Should the FDA authorize the vaccine, a separate committee convened by the Centers for Disease Control and Prevention will meet to make recommendations on its use later this week.

The same FDA committee will also meet Wednesday to consider whether the Pfizer/BioNTech and Moderna vaccines should be authorized for children as young as six months old.

Despite their unanimity on the decision to authorize the vaccine, the panelists did have concerns about how details on use of the vaccine would be communicated to the public, about heart inflammation that can rarely occur with both Covid vaccines, and about the next steps that should be taken in developing the vaccines.

One concern is that even though the Moderna vaccine is being authorized as a two-dose series, most experts thought that, as with the Pfizer-BioNTech vaccine, a third dose would be needed before recipients are really protected from new strains such as Omicron or the subvariants of Omicron that are currently circulating.

Paul Offit, of the Children’s Hospital of Philadelphia, made a “plea” to CDC officials present at the meeting to make sure this is clear in the agency’s messaging.

“Use your considerable influence at the CDC to please make sure that this two-dose series is not described as being fully vaccinated,” Offit said.

A third dose of the Moderna vaccine is not yet authorized, but the CDC has said that adults who got one vaccine can safely get a different vaccine as a booster.

Another concern was about the risk of myocarditis and pericarditis, rare side effects of the vaccine that occur mainly in adolescent males. The side effects are reported 46.4 times per million doses administered to males ages 12 to 15 and 75.9 per million times per million doses in males ages 16 to 17 with the Pfizer vaccine.

Some studies have indicated that the risk of the heart side effects might be higher with the Moderna vaccine, with some studies showing a doubling of risk or more. But the FDA, based on analyses of its own databases of insurance claims, said that it is not seeing a difference in risk between people who have received the two vaccines.

“I am a little bit sobered by the myocarditis data and the frequency with which that is occurring,” said Mark Sawyer, a panelist and professor of pediatrics at the University of California, San Diego. “So that clearly needs to be watched going forward as we expand the use of the vaccine.”

He pointed to data showing that increasing the time between the first and second doses of the vaccines, and asked the FDA and the manufacturers to consider a path to changing the dosing schedule for some people.

Researchers presenting to the panel also showed data indicating that the risk of Covid to children in this age group is substantial both when compared to other diseases for which vaccines are used and other potential causes of death, with Covid ranking as one of the top causes of death in most age groups over this time period.

Evan Anderson of Emory University presented data showing that 644 adolescents and children have died from Covid over the course of the pandemic, with 364 dying from the virus in 2021. That, he pointed out, was more children than were killed in the first year of the H1N1 influenza pandemic, and far more than regularly died from rubella, hepatitis A, or rotavirus, all of which are diseases for which children now routinely receive vaccines.

Panelists were also concerned that children are being vaccinated at rates substantially lower than adults.

Another concern was the lack of ethnic diversity in Moderna’s studies of children, a stark contrast with the earlier studies conducted in adults. Adam Berger, a panelist and a researcher at the National Institutes of Health, noted that when looking at the immune response in children 12 to 17, the data were based on hundreds of subjects who were white but only four who were Black.

In response, Peter Marks, the director of the FDA’s Centers for Biologics Evaluation and Research, said that although the trial fell short in terms of diversity, there has been no evidence that people of different ethnic backgrounds mount differing immune responses to the vaccine.