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  • USFDA flags heart...

USFDA flags heart inflammation risk after taking Novavax COVID vaccine

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-06-04T15:09:24+05:30  |  Updated On 4 Jun 2022 3:09 PM IST
USFDA flags heart inflammation risk after taking Novavax COVID vaccine
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The FDA said it had requested Novavax to flag myocarditis and another kind of heart inflammation as an "important identified risk" in its materials.

New York: US Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc's vaccine, even as the company's data showed the vaccine was effective in reducing the risk of mild-to-severe Covid-19.

In the company's nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of myocarditis, a type of heart inflammation also associated with mRNA vaccines, detected within 20 days post vaccination.
Read also: Novavax 2022 COVID vaccine deliveries off to slow start, shares drop
One patient in the trial reported myocarditis after receiving placebo. "These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA Covid-19 vaccines," the FDA staff wrote in briefing documents released on Friday.
Read also: Novavax seeks Taiwan FDA emergency use nod for COVID-19 vaccine
Shares of the company fell nearly 14% after the FDA's analysis of data from the company's trial.
The FDA said it had requested Novavax to flag myocarditis and another kind of heart inflammation as an "important identified risk" in its materials. The company had not yet agreed to do so. Novavax said the number of myocarditis events in its clinical trial was "within the range of expected background cases."

Read also: Novavax seeks UK nod for Nuvaxovid use in adolescents aged 12 through 17 years

USFDAheart inflammationNovavaxnovavax newscoronavirus vaccinecovid19coronavirusmyocarditismRNA vaccines
Source : Reuters
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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