Novavax (NVAX) Stock Falls 25% on FDA Heart Inflammation Warning

  • Novavax (NVAX) is slipping on an FDA warning for its Covid-19 vaccine.
  • The FDA wants NVAX to list heart inflammation warnings on the vaccine.
  • The company argues cases of this are limited enough to not need to list it.
NVAX Stock - Novavax (NVAX) Stock Falls 25% on FDA Heart Inflammation Warning

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Novavax (NASDAQ:NVAX) stock is falling on Friday after the U.S. Food and Drug Administration (FDA) requested a heart inflammation warning for its Covid-19 vaccine.

The FDA is currently evaluating the Covid-19 vaccine from Novavax and could approve it on Tuesday. However, it first requested the company to list myocarditis and pericarditis as an “important identified risk.”

Novavax hasn’t agreed to do so and argues the cases of heart inflammation during its clinical trials are within expected levels. Of the 30,000 patient in the trial, four reported myocarditis within 20 days of receiving the vaccine.

An FDA staff member had the following to say about the Covid-19 vaccine in a statement to Reuters.

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 negative reaction to the FDA warning has NVAX stock seeing heavy trading on Friday. This has some 10 million shares of the stock on the move as of this writing. To put that in perspective, the company’s daily average trading volume is closer to 4.7 million shares.

NVAX stock is down 25.7% as of Friday afternoon and is down 71.1% since the start of the year.

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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.


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