The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) on Wednesday authorized a first booster dose of Novavax’s COVID-19 vaccine for adults, including those who received Pfizer, Moderna or Johnson & Johnson as their primary series. The FDA, in a factsheet for healthcare providers, said adults ages 18 and older […]
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EU Says Novavax COVID Vaccine Must Carry Heart Inflammation Warning
The European Medicines Agency (EMA) is requesting more data from U.S. vaccine maker Novavax and said its COVID-19 vaccine — marketed under the brand names “Nuvaxovid and Covovax” — carry a warning of two types of heart inflammation after a small number of cases were reported in those who received the vaccine. According to a […]
FDA Experts Recommend Emergency Authorization of Novavax COVID Vaccine, Ignore Risk of Heart Inflammation
The U.S. Food and Drug Administration’s (FDA) vaccine advisors recommended the Novavax COVID-19 vaccine for emergency use authorization on Tuesday, paving the way for a fourth U.S. vaccine. The panel’s vote was 21 in favor of authorizing Novavax and one abstention. However, FDA authorization could be delayed because the company informed the agency just four […]