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The health department is investigating reports of this rare side effect of Moderna – so there is a complete re-evaluation of the vaccine and its approval, especially for adolescents!
Moderna vaccine with bad news
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Parents across the country celebrated on October 29 when the U.S. Food and Drug Administration (FDA) approved the use of BionTech/Pfizer’s vaccine for children ages 5-11, also a finger pointing to Europe! Children are now one step closer to being vaccinated against COVID with BionTech/Pfizer, and adolescents ages 12 to 15 have been receiving vaccines from Pfizer since May. The path for Moderna, on the other hand, has been less straightforward. While the vaccine maker filed for FDA approval for children ages 12 to 17 in June, the agency has yet to approve Moderna for anyone under 18 – and the company’s latest update suggests that might not happen until 2022, and the agency is even looking into a new side effect!
Health agency postpones approval!
On October 31, Moderna released a statement saying that the FDA had notified the company that it needed more time to evaluate the use of Moderna’s COVID vaccine in adolescents due to reports of a rare but serious side effect in young people. The statement said, “On Friday evening, the FDA notified Moderna that the agency needs additional time to evaluate recent international analyses of the risk of myocarditis following vaccination.” Because further analysis is needed, the FDA may not complete its evaluation of Moderna’s vaccine in adolescents until January 2022 – seven months after the company’s original submission.
Another side effect under investigation
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According to the Centers for Disease Control and Prevention (CDC), myocarditis is an inflammation of the heart muscle. Although considered an extremely rare side effect of vaccination, the CDC notes that cases of myocarditis and pericarditis (inflammation of the outer lining of the heart) were most commonly reported in young men after the second dose of mRNA-COVID vaccines, such as Pfizer and Moderna. The CDC adds, “Most patients with myocarditis or pericarditis who were treated responded well to medication and rest and felt better quickly.”
The FDA’s decision to further assess the risk of myocarditis before approving the Moderna vaccine for adolescents comes after several European countries suspended use of the vaccine in young people. As reported by the AP news agency, Finland suspended the administration of Moderna to men under 30 on Oct. 8 because the Finnish Institute of Health and Welfare said there was an increased risk of myocarditis in young men and boys after vaccination.
Scandinavian countries are already rejecting the vaccine
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Previously, the AP reports, Sweden had stopped giving Moderna to people under 30, Denmark had suspended its use in people under 18, and Norway recommended that those under 30 get vaccinated with Pfizer’s vaccine instead. All of these countries based their decision on an unpublished study by the Swedish National Board of Health that suggested younger Moderna recipients were at “increased risk of side effects such as myocarditis or pericarditis.” The study, which is currently under review by the European Medicines Agency’s Committee on Adverse Reactions, said the risk was “very low.”
For its part, Moderna claims the vaccine is safe and effective in younger recipients. “It is estimated that over 1.5 million adolescents have received the Moderna COVID-19 vaccine. To date, the rate of myocarditis reports in under-18s observed in Moderna’s global safety database does not suggest an increased risk of myocarditis in this population,” the Oct. 31 statement said.
Adverse reaction remains rare!
A pediatrician and member of the vaccination panel told The New York Times that even with a slightly increased risk of myocarditis in adolescents from Moderna, COVID infection itself is much more likely to cause myocarditis. Moreover, cases of myocarditis associated with vaccination are usually mild and resolve quickly – and are still quite rare.
Still, the FDA is being extra cautious about approving Moderna for adolescents. The vaccine maker said in its statement, “The safety of those vaccinated is of paramount importance to Moderna. The company is committed to working closely with the FDA to support its review and is grateful to the FDA for its diligence.”