Moderna dives as FDA delays Covid vaccine in teens due to ‘rare’ side effect
Moderna’s stock fell on Monday after the Food and Drug Administration delayed authorization of its Covid vaccine in adolescents, citing the risk of myocarditis.
Myocarditis is a form of inflammation of the heart that occurred after the second dose of Modern‘s (MRNA) and Pfizer‘s (PFE) Vaccines against covid. The condition has occurred mainly in boys and young men. Moderna is currently seeking approval for its Covid vaccine in adolescents 12 to 17 years old.
Now, the FDA review might not be complete until January 2022, Moderna said in a press release. In the meantime, the company has said it will delay submitting its vaccine application for children aged 6 to 11.
“The safety of the vaccinated is of paramount importance to Moderna,” Moderna said in a press release. “The company is fully committed to working closely with the FDA to support its review and is grateful to the FDA for its diligence.”
At today’s stock market, Moderna stock fell 2.3% to 337.17.
Moderna Stock: FDA delays vaccine in adolescents
The news comes days after the FDA cleared Pfizer’s Covid vaccine and BioNTech (BNTX) in children 5 to 11 years old. The vaccines from Pfizer and Moderna both belong to the class of messenger RNA vaccines. These vaccines hijack the body’s method of making proteins to trigger an immune response.
But both are also linked to the risk of myocarditis. Moderna’s stock fell earlier this year when the FDA began reviewing cases of post-vaccination myocarditis.
Before approving the Pfizer vaccine for children, an expert advisory group debated the risks of the two-dose regimen in young boys. They wondered if the dose of a third would still carry a risk of myocarditis. In the end, 17 of the 18 members voted in favor, saying the evidence confirms that the benefits outweigh the risks of the vaccine. One member abstained.
Moderna noted that cases of myocarditis were rare and generally mild, according to the Centers for Disease Control and Prevention and the World Health Organization. The company estimates that more than 1.5 million adolescents have received Moderna’s Covid vaccine.
“To date, the observed rate of myocarditis reports in under-18s in Moderna’s Global Safety Database does not suggest an increased risk of myocarditis in this population,” the company said in its press release. .
Highly listed biotech stocks
Moderna stock tumbled last month. But stocks always have a strong Relative Strength Rating of 98 out of a 99 best possible, according to Digital ITN. This places the Moderna stock in the top 2% of all stocks in terms of 12 month performance.
But the biotech industry group has an average rank, ranking 91st out of 197 groups tracked by Investor’s Business Daily.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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