A group of Food and Drug Administration experts will meet on Tuesday to discuss the Novavax Covid (NVAX) vaccine, temporarily halting the trading of NVAX shares.
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The meeting is an important step ahead of the possible authorization of the two-dose vaccine. At the end of the day, panelists will vote on whether the benefits of Novavax shooting outweigh its risks to adults. The FDA often follows the committee’s recommendation.
If successful, the two-dose vaccine could offer an alternative for people who are reluctant to receive Pfizer (PFE) or Modern (MRNA) messenger RNA vaccines. Novavax injection is based on protein technology, a more established platform than new mRNA injections.
But NVAX shares remain under pressure. As of Monday’s close, stocks were below their 50- and 200-day moving averages, according to MarketSmith.com.
NVAX Stock: Advisory Committee Key
A key point for the advisory committee will be the incidence of cardiac inflammation in Novavax vaccine recipients. In a statement released Friday, the FDA noted that there were six cases of heart inflammation, known as myocarditis and pericarditis, in vaccine recipients. In comparison, there was only one case in a placebo receptor.
Of the six cases, four occurred in men under 30 years of age. The FDA said it could not rule out a causal link between the Novavax vaccine and myocarditis cases, which caused the NVAX stock to sink. But Novavax argued that this demographic group has a high risk of myocarditis due to a viral infection. In fact, myocarditis is a risk of Pfizer and Moderna vaccines in young men and children.
“We have learned that we can expect to see natural myocarditis events in any database large enough and that young men have a higher risk,” Novavax said in a written statement. “Myocarditis is most often caused by nonspecific viral infections.”
The company said there was “not enough evidence to establish a causal relationship” between its vaccine and episodes of myocarditis / pericarditis. However, NVAX shares fell 20% on Friday.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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