A new safety signal associated with mRNA COVID-19 vaccination has been detected by the U.S. Food and Drug Administration (FDA) among toddlers, prompting calls for further evaluation and more robust studies. According to a preprint study published Oct. 15 on medRxiv, a statistical signal was detected for seizures/convulsions in children aged 2 to 4 who […]
Novavax
FDA, CDC Authorize ‘Mix and Match’ Novavax COVID Booster for Adults, Bypass Advisory Panels
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 […]
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 […]