COVID-19 Resource Center

COVID-19 Resource Center

Perspective from Mariska S. Kemna, MD
Source:

Moderna. Moderna provides update on timing of U.S. emergency use authorization of its COVID-19 vaccine for adolescents. https://investors.modernatx.com/news-releases/news-release-details/moderna-provides-update-timing-us-emergency-use-authorization. Accessed Nov. 1, 2021.

November 01, 2021
1 min read
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FDA delays decision on Moderna vaccine for adolescents over myocarditis risk

Perspective from Mariska S. Kemna, MD
Source:

Moderna. Moderna provides update on timing of U.S. emergency use authorization of its COVID-19 vaccine for adolescents. https://investors.modernatx.com/news-releases/news-release-details/moderna-provides-update-timing-us-emergency-use-authorization. Accessed Nov. 1, 2021.

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According to Moderna, the FDA said it will need more time to review the company’s request for an emergency use authorization of its COVID-19 vaccine in adolescents to further review the risk for myocarditis in this population.

Moderna said the FDA may need until January to evaluate recent international analyses of the risk.

Source: Adobe Stock.
The FDA has delayed its decision to authorize the Moderna vaccine in adolescents. Source: Adobe Stock.

Reports have described an increased risk for myocarditis from COVID-19 messenger RNA vaccines, particularly among younger men and after the second dose. Moderna noted that the CDC and WHO have said that cases are rare and generally mild.

CDC Director Rochelle P. Walensky, MD, MPH, said Monday that there should be no delay in getting adolescents vaccinated because the Pfizer vaccine is already available to them.

“All of these vaccines are thoroughly vetted and reviewed, and the data is publicly and transparently reviewed in our advisory committee,” Walensky said during a White House press briefing.

“The thing that is important is, we have a vaccine for adolescents that is the age demographic under consideration with Moderna, and that is the Pfizer vaccine that has undergone that review. We anticipate there should be no challenge in getting adolescents vaccinated,” she said.

Moderna filed its request back in June, seeking an EUA for children aged 12 to 17 years. The request was based on data from a phase 2/3 study showing that the vaccine offers similar levels of protection for adolescents as it does for adults.

Because of the delay, Moderna said it will postpone the filing of another EUA request for a 50 µg half-dose of the vaccine for children aged 6 to 11 years. That is also the size of the Moderna booster shot.