VRBPAC unanimously backs Moderna vaccine for children 6 and up

Regulatory NewsRegulatory News | 14 June 2022 |  By 

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend Moderna’s COVID-19 vaccine as a two-dose series for emergency use authorization (EUA) in children 6 years and older.
The committee met on Tuesday to discuss Moderna’s COVID-19 vaccine EUA request to include children and adolescents 6 years through 17 years of age. Moderna sought an EUA for a two-dose primary series for adolescents 12-17 years old at a 100 μg dose level given 1 month apart, and a two-dose primary series for children 6-11 years old at a 50 μg dose level given 1 month apart.
The questions posed to the 22-person committee were whether the benefits outweighed the risks for the vaccines in each age group. While FDA isn’t required to follow the recommendations of VRBPAC, it usually does.
Moderna’s vaccine, also known as Spikevax, was approved by the FDA through a biologics license application (BLA) in January 2022 for adults at a 100 μg dose level. FDA has also issued an EUA for Moderna’s vaccine as a half-strength booster dose for individuals 18 years and older, and as a second half-strength booster dose for individuals 50 years and older. Outside the US, Moderna has been approved or authorized in 86 countries for adults as a primary dose, and in 48 countries as a booster dose.
During its presentation at the meeting, the Centers for Disease Control and Prevention highlighted a safety concern for myocarditis and pericarditis in adolescents, but not in children 6-11 years old. FDA’s presentation also noted that current US surveillance data comparing myocarditis and pericarditis risk for young males who received the Moderna and Pfizer-BioNTech COVID-19 vaccine do not show a significantly higher risk with the Moderna vaccine compared with the Pfizer-BioNTech vaccine.
Moderna presented data from Study 203, which evaluated adolescents 12-17 years old who received a full-strength dose of the Moderna vaccine, and study 204, which evaluated children 6-11 years old who received a half-strength dose version of the vaccine. When compared against immunogenicity data from study 301 of young adults 18-25 years old, Moderna’s vaccine showed similar neutralizing antibody geometric mean titers across age groups.
Following CDC’s presentation, committee members questioned the hospitalization rate in children during the omicron wave. James Hildreth, Sr., MD, PhD, with the Department of Internal Medicine School of Medicine President and Chief Executive Officer Meharry Medical College in Nashville, commented on the data indicating a majority of children have been infected with COVID-19, noting that the statistic implies the true rate of hospitalization is “vanishingly small.”
After the unanimous vote, Cody Meissner, MD, director of pediatric infectious diseases at Tufts University School of Medicine in Boston, said he thought it was helpful for people to have options in terms of COVID-19 vaccines.
Amanda Cohn, MD, US Public Health Services Chief Medical Officer at the National Center for Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention agreed that the benefits outweigh the risks as a two-dose vaccine for both age groups. “I think this vaccine has met the exact same level of criteria that we voted for FDA to authorize for the Pfizer vaccine, so I am fully in support of this,” she said.
Mark Sawyer, MD, FAAP, vice chair for the Education Department of Pediatrics at the University of California San Diego School of Medicine, said he concurred that the benefits outweighed the risks for these indications, but is concerned about the myocarditis data presented. “I am a little bit sobered by the myocarditis data and the frequency with which that is occurring, so that clearly needs to be watched closely going forward as we expand the use of the vaccine,” he said.
Paul Offit, MD, professor of pediatrics at The Children’s Hospital of Philadelphia, took a different position than his colleagues on the advisory committee. “We’re at a different part in this pandemic,” he said. “The question is, will two doses of this vaccine offer adequate protection against omicron subvariants? And I think the answer is certainly regarding mild illness, no, and I think with regard to severe illness, yes, as long as there’s a third dose.”
“I feel uncomfortable saying that this is same place where Pfizer was when it was submitted, because it’s not. I’m comfortable saying the benefits clearly outweigh the risks, but I say that with the comfort being provided that there will be a third dose. Because if that was not true, I wouldn’t feel the same way,” Offit said. We’re not in the same part of this pandemic anymore. It’s a different time.”
Responding to Offit’s comment, Eric J. Rubin, MD, PhD, of the Harvard TH Chan School of Public Health in Boston, agreed, but said, “We’re always going to be behind the 8-ball” in terms of looking at data from previous COVID-19 variants when making recommendations to FDA. “That’s how long it takes to produce these data. We have to make decisions based on the best data we have, which is always going to be old data in an outbreak that’s constantly moving,” he said.
VRBPAC will reconvene on Wednesday to vote on expanding the EUA for Moderna’s vaccine for children 6 months to 5 years old and expanding Pfizer-BioNTech’s vaccine for children 6 months to 4 years old.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you