FDA committee recommends Pfizer-BioNTech, Moderna COVID-19 vaccines for kids 6 months and older

In the last 2 days, the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) made pivotal recommendations in relation to both the Moderna COVID-19 mRNA vaccine, mRNA-1273, (Spikevax), and Pfizer-BioNTech mRNA version, BNT162b2, (Comirnaty) and its access for pediatric patients.¹

The committee unanimously voted 21-0 to recommend emergency use authorization (EUA) of the Pfizer-BioNTech vaccine for children aged 6 months to 4 years and recommended to split the vote on 2 age groups of the Moderna vaccine due to dosing differences.

These 2 votes based on dosing differences resulted in an EUA authorization for children aged 6 to 23 months and 2 to 5 years old. Additionally, the VRBPAC yesterday decided to recommend expanding Moderna’s EUA to children aged 6 to 17 years.

The questions considered by the committee were benefit vs risk ratios on whether the EUAs should be extended to the youngest age groups evaluated in both Moderna’s and Pfizer’s clinical trials. Moderna’s vaccination model for use in children is a 2-dose approach, taken 1 month apart. In comparison, Pfizer asked the committee to vote in favor of a 3-dose process. With these updates, the committee says that all Americans aged 6 months and older have access to a mRNA COVID-19 vaccine.²

Now, the FDA and the Centers for Disease Control and Prevention (CDC) will begin its review process and decide whether to agree with the VRBPAC recommendation. Of note, both the FDA and CDC have historically followed VRBPAC endorsements for vaccine authorizations.

“I know that the death rate from COVID in young children may not be extremely high, but it’s absolutely terrifying to parents to have their child be sick, have to go to the hospital, or even go to the emergency room or their primary care doctor because they’re sick and having trouble breathing,” said Jay Portnoy, MD, professor of pediatrics at Children’s Mercy Hospital in Kansas City, Missouri, after being moved by the public comment portion of the meeting in which parents shared their experiences of trying to keep their children safe from COVID-19. “It’s not just doubts. We have to understand how distressing this is for parents whose children are affected by this disease.”³

Arthur Reingold, MD, professor of epidemiology division head in the Epidemiology School of Public Health at the University of California, Berkeley, also said that making the vaccines available to this patient population is reasonable based on its benefits vs risks.

“I would point out that we as a country continue to give a large number of vaccines to children where the risk of the child dying or being hospitalized of those diseases is pretty close to zero,” he said in the meeting. “I do think we do need to focus on the serious outcomes, even if they’re relatively infrequent, and even if a vaccine is less than 100% effective.”

References:

1. Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 meeting announcement. US Food and Drug Administration. Accessed June 16, 2022. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-14-15-2022-meeting-announcement#event-materials
2. Craven J. VRBPAC recommends Pfizer, Moderna COVID vaccines for youngest children. Regulatory Affairs Professionals Society. Article. Published June 15, 2022. Accessed June 16, 2022. https://www.raps.org/news-and-articles/news-articles/2022/6/vrbpac-recommends-pfizer-moderna-covid-vaccines-fo
3. Craven J. VRBPAC unanimously backs Moderna vaccine for children 6 and up. Regulatory Affairs Professionals Society. Article. Published June 14, 2022. Accessed June 16, 2022. https://www.raps.org/news-and-articles/news-articles/2022/6/vrbpac-unanimously-backs-moderna-vaccine-for-child