FDA delays decision on Moderna vaccine for adolescents over myocarditis risk
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.
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.
Perspective
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I think it is a prudent move by the FDA to take its time to scrutinize all national and international data before reaching a final decision. Because myocarditis is a rare side effect, an increased risk may not be evident in all studies because it will depend on the size of the study population and the age of the participants.
We now know that there is small risk for myocarditis with the mRNA vaccines, especially for young males after their second vaccine. There are some signals that risk could be higher with Moderna compared with Pfizer, which is why some countries decided to avoid Moderna for young males. However, that signal is not consistently present. It may have to do with the dosing of the vaccine, and Moderna’s dose may be relatively higher than Pfizer’s.
Young males could potentially benefit from lower doses of both mRNA vaccines — Pfizer’s and Moderna’s — or an adjusted vaccination schedule to lower their risk for vaccine-associated myocarditis because they have very responsive and robust immune systems. Because teenagers can already be protected from COVID-19 with Pfizer’s vaccine, it seems wise for the FDA to allow for more time rather than rush a decision.
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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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