FDA staff on Friday flagged the risk of heart inflammation following the administration of the Novavax COVID-19 vaccine.
In the company’s nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of myocarditis detected within 20 days post-vaccination, the Epoch Times reports.
One patient in the trial reported myocarditis after receiving a placebo.
“These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines,” FDA staff wrote in briefing documents.
“Data from passive surveillance during post-authorization use in other countries also indicate a higher than expected rate of myocarditis and pericarditis (mainly pericarditis) associated with the vaccine. However, interpretation of these passive surveillance data is not straightforward, and further evaluation is needed to inform the risk of myocarditis and pericarditis associated with this vaccine, and their outcomes, as additional data emerge over time,” they continued.
The agency said it asked Novavax to flag the risk of myocarditis and pericarditis, another type of inflammation of the heart, as an identified risk.
“Based on the efficacy estimate in the clinical trial of this vaccine,” the FDA staff wrote, “it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease.”
A committee of the FDA experts is scheduled to speak and vote on the authorization of the vaccine for adults on June 7th.
“The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older,” the FDA website reads.