The Food and Drug Administration suggested Friday there could be a link between Novavax's (NVAX) Covid vaccine and heart inflammation, and NVAX stock plummeted.
XIn briefing documents posted ahead of a critical meeting next week, the FDA said there were six cases of either myocarditis or pericarditis — heart and tissue inflammation — in recipients of Novavax's vaccine. Of those, five occurred in males, ages 16-67. There was one case in a placebo recipient.
The events suggest there could be a "causal association" between Novavax's Covid vaccine and heart inflammation, the FDA said. Representatives of the company didn't return a request for comment from Investor's Business Daily on Friday.
In response, NVAX stock tumbled 20% to 44.76 on today's stock market.
NVAX Stock: Heart Inflammation Mostly In Men
Messenger RNA-based, or mRNA, Covid vaccines from Pfizer (PFE) and Moderna (MRNA) are tied to myocarditis and pericarditis in boys and young men. For that reason, the FDA ran a supplemental analysis of those side effects.
Of the six heart inflammation cases in vaccine recipients, four occurred in males under the age of 30. A 67-year-old man and a 60-year-old woman also experienced myocarditis and pericarditis, respectively. Most events took place within 10 days of a Novavax shot — a bearish point for NVAX stock.
Only one of the events had a clear alternative explanation, as the recipient had Covid. Covid can also lead to myocarditis and pericarditis.
"Other events had only circumstantial evidence of potentially plausible alternative etiologies," the FDA said in its document. Further, "four of the events occurred in young men, a subject population known to be at higher risk of mRNA Covid-19 vaccine-associated myocarditis."
Advisory Committee Meeting Scheduled
The briefing document comes ahead of an FDA advisory committee meeting on Tuesday to discuss the Novavax Covid vaccine. A positive vote could prod NVAX stock higher. If authorized, the vaccine could offer an alternative to people concerned about the newer mRNA technology. Novavax uses protein technology in its vaccine.
But NVAX stock has trended down since mid-December. Shares are now well below their 50-day line, according to MarketSmith.com.
The downfall comes as Novavax works to launch its vaccine broadly. Novavax's vaccine is available in Europe, Australia, Indonesia and South Korea, among other geographies. The company projects $4 billion to $5 billion in full-year sales.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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