COVID-19: risk of myocarditis with Novavax vaccine raises concerns

The Novavax vaccine is already authorized in other countries, especially in Europe and Canada.

In the United States, an independent committee meeting at the FDA’s request will meet Tuesday to review data from Novavax’s clinical trials and to make its recommendation. Upstream, the agency published on Friday a lengthy document examining these results, as it did for three other vaccines already authorized in this country.

As a result, Novavax’s title fell 20% on the New York Stock Exchange.

The Novavax vaccine was found to be 90% effective against COVID-19 symptoms in trials conducted before the Omicron variant came out, according to the FDA.

However, six cases of myocarditis, an inflammation of the heart muscle, were seen in the group receiving the vaccine, versus one case in the placebo group, the agency pointed out. Five cases occurred within two weeks following vaccination.

The detection of several cases possibly related to the vaccineof 40,000 participants in the clinical trial, raises the following concern: if there is a link cause, the risk of myocarditis following NVX-CoV2373 vaccination may be higher than observed during post-authorization of messenger RNA vaccinesexplained by the FDA in its review.

Not enough proofsays the company

The risk of myocarditis is actually observed after vaccination of Pfizer or Moderna vaccines, especially in young men and young men. However, the FDA recalled that in clinical trials of these vaccines, no cases have yet been identified. So he seems worried that this risk is higher with the Novavax vaccine.

The company released a response statement on Friday: We believe there is insufficient evidence to establish a causal relationship between cases of myocarditis and the vaccine, he said, adding that this was normal to expect to see a number of myocarditis still occur within the population in any large database.