A panel of Food and Drug Administration experts is meeting Tuesday to discuss Novavax‘s (NVAX) Covid vaccine — leaving NVAX stock trading temporarily halted.
The meeting is an important step ahead of potential authorization of the two-dose vaccine. At the end of the day, panelists will vote on whether the benefits of the Novavax shot outweigh its risks for adults. The FDA often follows the committee’s recommendation.
If successful, the two-dose vaccine could offer an alternative for people reluctant to receive Pfizer‘s (PFE) or Moderna‘s (MRNA) messenger RNA vaccines. Novavax’s shot is based on protein technology, a more established platform than the newer mRNA shots.
NVAX Stock: Advisory Committee Key
A key point for the advisory committee will be the incidence of heart inflammation in recipients of the Novavax vaccine. In briefing documents posted Friday, the FDA noted there were six cases of heart inflammation — known as myocarditis and pericarditis — in recipients of the vaccine. In comparison, there was just one case in a placebo recipient.
Of the six cases, four occurred in males under the age of 30. The FDA said it couldn’t rule out a causal relationship between Novavax’s vaccine and the cases of myocarditis, causing NVAX stock to dive. But Novavax argued this demographic is at a heightened risk of myocarditis due to viral infection. In fact, myocarditis is a risk of Pfizer’s and Moderna’s vaccines in young men and boys.
“We have learned that we can expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk,” Novavax said in a written statement. “Myocarditis is most often caused by nonspecific viral infections.”
The company said there’s “insufficient evidence to establish a causal relationship” between its shot and episodes of myocarditis/pericarditis. Still, NVAX stock tumbled 20% on Friday.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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