The Food and Drug Administration is delaying a decision on authorizing Moderna Inc.’s MRNA -1.69% COVID-19 vaccine for adolescents to assess whether the shot may lead to heightened risk of a rare inflammatory heart condition, according to people familiar with the matter.
After four Nordic countries strengthened their stances against giving Moderna vaccines to younger adults last week, the FDA has been taking another look at the risk of the condition, known as myocarditis, among younger men who took Moderna’s vaccine, especially compared with those who received the vaccine from Pfizer Inc. and BioNTech SE, the people said.
So far, the regulators haven’t determined whether there is an elevated risk, the people said. The delay could be several weeks, but the timing is unclear, one of the people said.
The agency plans to further review data before deciding on whether to extend the vaccine’s eligibility to younger people, the people said.
Myocarditis risk is the latest complication for vaccine makers, regulators and public-health authorities who have been encouraging vaccination to protect against COVID-19, after a rare blood-clotting condition hurt the rollout of AstraZeneca PLC and Johnson & Johnson shots.
The risk of myocarditis has also been an issue among many open to vaccination but concerned about side effects.
Parents eager to inoculate their adolescents still have access to the Pfizer-BioNTech vaccine. The authorization delay could add to the hesitancy of some who have held off due to safety concerns. The FDA’s caution could, however, also ease the minds of some hesitant parents.
Depending on what the FDA decides, Pfizer’s vaccine may become the preferred shot for adolescents and children as the U.S. expands its vaccine rollout, further bolstering its leading position in the U.S. and global market.
Moderna Chief Medical Officer Paul Burton said the FDA’s own data on vaccinations among 18-to-25-year-olds doesn’t show any significant difference in the rate of myocarditis among people who took the Moderna or Pfizer-BioNTech vaccines.
“I think people can be reassured that the risk of myocarditis with an mRNA vaccine is low, it appears to be balanced between the different products,” he said in an interview.
Dr. Burton said Moderna has asked the Nordic countries for their data but hasn’t yet seen it.
Chief Executive Stéphane Bancel said during an interview this week that the benefits of the company’s vaccine, including its strong and long lasting protection, outweigh the risks.
“Some countries want to be ultraconservative, it’s of course their prerogative, but with the data I’ve seen I would be comfortable with anybody in my family who is a young male getting the vaccine,” he said.
This is an excerpt from Fox News.
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