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Many high-risk patients with mild to moderate COVID-19 symptoms who are eligible for monoclonal antibodies don’t get them for a multitude of reasons. The report states that “the overall analysis predicted that the numbers of clinically significant COVID-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases over a range of assumptions for COVID-19 incidence.” Moderna plans to submit the Spikevax data to the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other global regulators.Īhead of the scheduled meeting this week of the FDA’s Vaccines and Related Biological Products advisory committee, the agency posted a briefing document on myocarditis concerns with Pfizer's vaccine in children ages 5 to 11. “This interim analysis showed a robust neutralizing antibody response after two doses of mRNA-1273 at the 50 µg dose level with a favorable safety profile,” the company said in a press release. Moderna has announced top-line data from its pivotal study in children 6 to 11 years old. All of our COVID-19 coverage can be found on our COVID-19 Hub.
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In July 2021, we transitioned to Mondays, Wednesdays, and Fridays. Since March 2020, TCTMD reporter Todd Neale has been writing up breaking news and peer-reviewed research related to COVID-19 every weekday.