Oct 31, 2021 - Health

Moderna says FDA needs more time to assess risks of vaccine in teens

Photo: Miyer Juana/Long Visual Press/Universal Images Group via Getty Images

Moderna said Sunday that the Food and Drug Administration (FDA) is delaying a decision on approving the emergency use of the company's coronavirus vaccine for children ages 12 to 17.

Driving the news: The FDA informed Moderna that it is evaluating the risk of myocarditis, a condition affecting the wall of the heart, after vaccination, per the release.

  • Moderna said it will delay filing a request for emergency use authorization for children ages 6 to 11 while the FDA continues to assess the vaccine for children ages 12 to 17.
  • The FDA may not complete its review before January 2022, Moderna said in a press release.

What they're saying: "The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence," Moderna said in a statement.

  • "Moderna is committed to conducting its own careful review of new external analyses as they become available."
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