In reviewing clinical trial data related to the Novavax (Nasdaq:NVAX) COVID-19 vaccine, FDA expressed concerns about the product’s potential to cause myocarditis, a type of heart inflammation. In a briefing document, FDA noted that the “identification of multiple potential vaccine-associated cases in a premarket safety database of ~40,000 vaccine recipients raises concern.” The agency goes…
CDC recommends eight-week interval for some COVID-19 vaccine recipients
The CDC has recommended extending the interval between the first and second doses of the Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) COVID-19 vaccines up to eight weeks for some individuals. The guidance for those vaccines was formerly 21 and 28 days, respectively. CDC notes that an eight-week interval could be preferred for some individuals 12 and…
Pfizer and Moderna to expand clinical trials for school-aged children
As a result, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have agreed to expand clinical trials of their vaccines in children aged five to 11 before seeking emergency use authorization. In April, Israel first reported suspected cases of heart inflammation in recipients of the COVID-19 vaccine from Pfizer and its partner BioNTech. Since then, FDA has substantiated the risk of myocarditis,…
FDA plans to warn of rare myocarditis risk following COVID-19 vaccination
FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39. The conditions appear to be more common in males. The FDA warning…
Preliminary data point to possible link between myocarditis and mRNA COVID-19 vaccines
The theme of myocarditis and pericarditis following mRNA vaccination emerged in today’s Vaccines and Related Biological Products Advisory Committee meeting, which reviewed preliminary safety data of Pfizer-BioNTech vaccine in children aged 12 to 15. The risk, however, appears to be small. As of May 31, there were 116 reports of myocarditis or pericarditis after the…