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USFDA concerned about possible link to myocarditis Novavax


The United States Food and Drug Administration (USFDA) on Friday, June 4, expressed concern about the potential link of myocarditis to the Novavax Covid-19 vaccine. Experts will soon evaluate 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 evaluate the vaccine and give its recommendation. The committee was convened at the request of the USFDA.

The USFDA released a lengthy document analyzing data on the vaccine. It has done the same in the past for three other vaccines already authorized in the country.

After the USFDA document, Novavax stock fell 20% on the New York Stock Exchange.

Novavax’s vaccine was found to be 90% 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 that received the vaccine, six cases of myocarditis were discovered. Mysocarditis is an inflammation of the heart muscles. In the placebo group, such a case was found.

Five cases occurred within two weeks of vaccination.

“The identification of multiple potential vaccine-associated cases” out of 40,000 clinical trial participants” raises concerns that if causally linked, the risk of myocarditis after “Novavax injection” could be higher than that reported” on other vaccines such as Pfizer or Moderna, the FDA said.

(With agency contributions)

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Post expires at 1:04am on Tuesday June 14th, 2022