FDA Panel Unanimously Backs Moderna COVID Vaccine for Ages 6-17

Marcia Frellick

June 14, 2022

The US Food and Drug Administration's (FDA) vaccine advisory panel today unanimously recommended granting emergency use authorization (EUA) for Moderna's COVID-19 vaccine for ages 6-17 years.

The Moderna vaccine is currently fully approved for adults 18 years and older.

Two votes were taken by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) — one for the two-dose primary series in the 12-17 group (100 mg each) and one for the primary 2-dose series for 6- to 11-year-olds (50 mg each). In each age group the two doses would be given 1 month apart.

Both questions put to the committee centered on whether, given available scientific evidence, benefits of the vaccinations outweigh the risks for these age groups.

Both votes were 22-0 in favor of granting the EUA.

The votes were the first in a 2-day meeting. The panel's recommendation now goes to the full FDA for consideration. While the agency is not obliged to accept the recommendations of its panels, it usually does so.

The Centers for Disease Control and Prevention (CDC) will then need to endorse the approval to get the vaccine into the immunization schedule. The agency's own advisory panels meet later this week.

Wednesday Vote Considers Ages 5 and Younger

On Wednesday, the committee will consider approving EUAs for the Moderna vaccine for children between 6 months and 5 years and the Pfizer/BioNTech vaccine for kids 6 months through 4 years. The Pfizer vaccine is already fully approved for those age 5 and older.

In today's presentations to the FDA panel Moderna's Jacqueline Miller, MD, therapeutic area head for infectious diseases, reported that more than 8000 children aged 6-17 have been included in the clinical trials for the vaccine.

Efficacy evidenced in the trials was of 88%-100% against COVID-19 in this age group, which is consistent with the vaccine's performance in adults. The Moderna vaccine is generally well-tolerated and no new safety concerns have been identified, she reported.

Questions arose about the risk for myocarditis and pericarditis, which have been linked causally to the mRNA vaccines in some cases.

Tom Shimabukuro, MD, MPH, with the CDC's Immunization Safety Office, said myocarditis is a rare event following mRNA COVID-19 vaccinations in children 5-17 years, occurring in 635 verified cases out of the 54.8 million in that age group who received the Pfizer vaccine during the surveillance period.

Cases are generally clustered within the first week of vaccination and risk appears greatest in the 16-17 and 12-15 age groups. Myocarditis risk is generally higher after dose two and more common in males.

He noted that to date myocarditis and pericarditis have not signaled significantly in children ages 5-11. 

Unmet Need

Ruth Link-Gelles, PhD, MPH, an epidemiologist in the CDC's Division of Viral Diseases, spoke to the gap in vaccinations between age groups, saying, "Coverage remains lower for adolescents and children compared with adults and differ somewhat by race and ethnicity."

She reported there are 18 million children aged 5-11 currently unvaccinated and 8.5 million unvaccinated 12- to 17-year-olds.

In the 5- to 11-year-old group, 35.9% have at least one dose and 29.2% are fully vaccinated. In the 12- to 17-year-old group, 69.5% have at least one vaccine dose and 59.5% are fully vaccinated, she said.

Speakers in the public comment session were heavily in support of extending the EUAs to lower ages. A handful of commenters spoke out strongly against the vaccine, saying either they had physical effects they attributed to the vaccine or that a vaccine was not necessary given the level of risk of severe disease or death from COVID in children and adolescents.

Donald Middleton, MD, professor of family medicine at the University of Pittsburgh, Pittsburgh, Pennsylvania, spoke out strongly in the comment section in favor of the vaccine for children.

"Although COVID is often asymptomatic in children, some require hospitalization, the outcome of which sadly can be prolonged disability or death," he noted.

He asked, "Can you imagine the impact of the death of your child from COVID knowing that a vaccine could have protected against severe disease?" 

After today's vote, committee member Paul Offit, MD, vaccine specialist with the Children's Hospital of Philadelphia, made a plea to the CDC: "Please make sure that this two-dose series is not described as being fully vaccinated. This is a three-dose series if it is to be effective against these Omicron subvariants."

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at  @mfrellick.

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