USFDA expresses concern over possible Novavax myocarditis link

US Food and Drug Administration (USFDA), on Friday (June 4), voiced concern over potential myocarditis link to Novavax Covid-19 vaccine. Experts will soon weigh its use in the United States.

The Novavax vaccine is already authorized in other countries, particularly in Europe.

An independent committee is due to meet on Tuesday to evaluation the vaccine and give its recommendation. The committee has been convened at the request of USFDA.

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USFDA has published a lengthy document analysing data about the vaccine. It has done the same in past for three other vaccines which are already authorised in the country.

After USFDA's document, Novavax stock dropped 20 per cent on New York Stock Exchange.

Novavax's vaccine was found to be 90 percent effective against symptomatic cases of the disease, in trials conducted before the appearance of the Omicron variant, according to the FDA.

However in the group which was given the vaccine, six cases of myocarditis were found. Mysocarditis is inflammation of heart muscles. In the placebo group, one such case was found.

Five cases occurred within two weeks of vaccination.

"Identification of multiple potential vaccine-associated cases" out of 40,000 clinical trial participants "raises concern that if causally associated, the risk of myocarditis following" the Novavax shot "could be higher than reported" on other vaccines such as Pfizer or Moderna, the FDA said.

(With inputs from agencies)

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