![]() RELATED: This Is What Experts Want You to Know About the Moderna Booster.Tens of millions of people have already been vaccinated against SARS-CoV-2, and in the coming months, hundreds of millions more will follow. The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence." The vaccine manufacturer said in its statement, "The safety of vaccine recipients is of paramount importance to Moderna. Nevertheless, the FDA is being extra cautious before approving Moderna for adolescents. Beyond that, cases of myocarditis linked to vaccination tend to be mild and resolve quickly-and are still quite rare. Paul Offit, MD, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the FDA's vaccine advisory committee, told The New York Times that even with a slightly higher risk of myocarditis in adolescents from Moderna, a COVID infection itself is much more likely to cause myocarditis. To date, the observed rate of myocarditis reports in those less than 18 years of age in Moderna's global safety database does not suggest an increased risk of myocarditis in this population," the Oct. "It is estimated that over 1.5 million adolescents have received the Moderna COVID-19 vaccine. RELATED: For more up-to-date information, sign up for our daily newsletter.įor its part, Moderna maintains that the vaccine is safe and effective in younger recipients. ![]() The study, now being reviewed by European Medicines Agency's adverse reaction committee, said the risk is "very small." ![]() All of these countries made their decision based on an unpublished study from Sweden's Public Health Agency, which suggested "an increased risk of side effects such as inflammation of the heart muscle or the pericardium" in younger Moderna recipients. Prior to that, the AP reports, Sweden had stopped giving Moderna to anyone under 30, Denmark had suspended the use in people under 18, and Norway encouraged those under 30 to get the Pfizer vaccine instead. 2022-seven months after the company's initial application. Given the need for further analysis, the FDA may not complete its evaluation of the Moderna vaccine in adolescents until Jan. According to the statement, "On Friday evening, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination." 31, Moderna released a statement saying that the FDA had notified the company it would need more time to assess the use of Moderna's COVID vaccine in adolescents, because of reports of a rare but serious side effect in young people. RELATED: This One Vaccine Could End the COVID Pandemic, Experts Say. While the vaccine manufacturer applied for FDA authorization for children 12 to 17 in June, the agency has yet to approve Moderna in anyone under 18-and the latest update from the company suggests that might not happen until 2022. The journey for Moderna, on the other hand, has been less straightforward. Kids are now one step closer to being vaccinated against COVID with Pfizer, and adolescents 12 to 15 have been getting Pfizer shots since May. ![]() Food and Drug Administration (FDA) authorized the use of the Pfizer vaccine in children aged 5 to 11. Parents across the country celebrated on Oct. ![]()
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