Decision On Moderna's COVID-19 Vaccine For Adolescents Delayed - What You Need To Know

  • The FDA is delaying its decision to authorize Moderna Inc's MRNA COVID-19 vaccine for adolescents to assess the risk of a rare inflammatory heart condition, Wall Street Journal reported citing people familiar with the matter.
  • The agency has been inspecting the risk of myocarditis among younger men vaccinated with Moderna's shot, especially versus Pfizer Inc PFE and BioNTech SE's BNTX vaccine.
  • Related: After Sweden, Denmark Now Finland Stops Use of Moderna COVID-19 Jab In Young People: Report.
  • The agency has not yet determined whether there is heightened risk, and the delay could be several weeks, though the timing was unclear, the report said.
  • The agency plans to further review data before deciding whether to extend the vaccine's eligibility to younger people, the people said.
  • Moderna Chief Medical Officer Paul Burton said, "the FDA's data on vaccinations among 18- to 25-year-olds don't show any significant difference in the rate of myocarditis among people who took the Moderna or the Pfizer-BioNTech vaccines".
  • In June, Moderna filed for U.S. authorization of its vaccine among adolescents aged 12 through 17. 
  • Related: EMA Says Heart Inflammation Likely Linked To mRNA-Based COVID-19 Vaccines.
  • Price Action: MRNA shares closed higher by 3.28% at $334.84 on Monday.
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