White House: Delay in FDA’s Moderna review won’t impact pediatric vaccine rollout

The delay in the Food and Drug Administration’s (FDA) review of the Moderna COVID-19 vaccine for adolescents won’t impact the Biden administration’s vaccine rollout for children, White House officials said on Monday.

With the White House preparing for the potential forthcoming approval of the Pfizer-BioTech vaccine for 5 to 11 year olds, officials said the postponement of the FDA’s authorization of the Moderna vaccine for those aged 12 to 17 will not interfere with the pediatric vaccination program.

The FDA told Moderna that it needed more time to review its application for adolescents, in particular to analyze the risk of a rare heart side effect, the company said on Sunday. In response, Moderna plans to delay its application to authorize its vaccine for 6 to 11 year olds. 

But White House coronavirus coordinator Jeff Zients said that the government has enough Pfizer-BioNTech vaccine doses for the nation’s 28 million children aged 5 to 11, if and when the Centers for Disease Control and Prevention (CDC) issues recommendations on giving the doses to the younger population. 

“We’re in great shape on supply, and the whole plan is based on the Pfizer vaccine,” Zients said during a briefing. “So we have more than enough vaccines for every child 5 to 11, specifically the Pfizer vaccine.”

“Within minutes” of the FDA’s authorization on Friday, officials began the distribution process for 15 million of Pfizer-BioNTech doses. Additional millions of doses will become “available each and every week” at more than 20,000 sites, including pediatricians’ offices and pharmacies.

CDC Director Rochelle Walensky also noted that the Pfizer-BioNTech vaccine has already been authorized for 12 to 17 year olds – the age group that the FDA is currently reviewing for Moderna’s vaccine.

“So we anticipate there shouldn’t be any challenges with regard to getting those adolescents vaccinated,” she said during the briefing.

This week, the CDC’s advisory panel could give recommendations for the first COVID-19 vaccines to be given to 5 to 11 year olds, sparking a nationwide rollout for the age group if Walensky provides her endorsement.

The expansion of eligibility would come months after the CDC greenlit the Pfizer-BioNTech vaccine to be administered to 12 to 15 year olds in May, bringing vaccine access to adolescents for the first time.

Moderna submitted its request for the FDA emergency authorization for its vaccine to be given to 12 to 17 year olds in June, after previously announcing it was 100 percent effective at preventing infection in the age group.

But the approval for this age group could be delayed until early 2022 as FDA experts review data on rare cases of myocarditis, or heart inflammation, typically days after getting the COVID-19 vaccine. 

The CDC has said the uncommon condition has been reported following administration of the Pfizer-BioNTech or Moderna vaccines, with most cases among male young adults and adolescents.