The U.S. Food and Drug Administration hasraised concerns about a possible risk of heart inflammation from Novavax Inc's COVID-19 vaccine, even as the company's data showed it could reduce the chances of mild-to-severe disease.
A vial labelled "Novavax COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/IllustrationJune 3 - The U.S. Food and Drug Administration hasraised concerns about a possible risk of heart inflammation from Novavax Inc's
"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 released on Friday.Shares of the company fell nearly 14% after the FDA's analysis of data from the company's trial. "Based on our interpretation of all the clinical data supporting NVX-CoV2373 ... we believe there is insufficient evidence to establish a causal relationship," the company said in a statement.Novavax has said the shot, NVX-CoV2373, will play a role in driving vaccination among those who have been hesitant to get immunized and it has started an educational effort on vaccine choices.
"Based on the efficacy estimate in the clinical trial of this vaccine, 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," the FDA staff said.
Australia Latest News, Australia Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Novavax hopes its COVID shot wins over FDA, vaccine holdoutsGAITHERSBURG, Md. (AP) — Americans may soon get a new COVID-19 vaccine option -- shots made with a more tried-and-true technology than today’s versions. The big question: Why should they care? After long delays, the Food and Drug Administration is expected to decide within weeks whether to authorize Novavax's vaccine.
Read more »
Novavax hopes its COVID shot wins over FDA, vaccine holdoutsAmericans may soon get a new COVID-19 vaccine option — a more traditional kind of shot known as a protein vaccine.
Read more »
Q&A: Novavax hopes its COVID shot wins over FDA, vaccine holdoutsAmericans may soon get a new COVID-19 vaccine option — a more traditional kind of shot known as a protein vaccine.
Read more »
Can Novavax win over vaccine holdouts with its Covid shot?The late entrant into the U.S. vaccination effort uses the same technology seen in vaccines for hepatitis B and shingles, among others.
Read more »
How Long Are You Protected After Getting COVID and Can You Get COVID Twice?For those who test positive for COVID and experience symptoms, how long could they last?
Read more »