The European Medicines Agency (EMA) is recommending Novavax’s COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.
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Advisers to the U.S. Centers for Disease Control and Prevention (CDC) are meeting on Thursday to decide on the use of Moderna Inc.’s COVID-19 vaccine for children and adolescents aged 6 to 17, after months of delay in that age group due to safety concerns.
Moderna’s (MRNA.O) COVID-19 vaccine may have a higher risk of heart inflammation in young men than the Pfizer (PFE.N)/BioNTech (22UAy.DE) shot, according to data presented on Tuesday to U.S. Food and Drug Administration advisers weighing its use for those aged 6 to 17.
U.S. Food and Drug Administration staff reviewers on Friday said Moderna Inc.’s COVID-19 vaccine appears safe and effective for use in children aged 6 months to 17 years old as a committee of scientists will meet next week to vote on whether to recommend the regulator authorize the vaccine in children.
Advisers to the U.S. Food and Drug Administration will consider whether to recommend Novavax Inc.’s COVID-19 vaccine for adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics.
U.S. Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc.’s vaccine, even as the company’s data showed the vaccine was effective in reducing the risk of mild-to-severe COVID-19.
