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COVID-19

FDA Approves Moderna's New COVID-19 Vaccine, But with Limits

Strategic Insights

— 1 min read

The U.S. has approved a new COVID-19 vaccine made by Moderna, with limitations on who can use it. The new vaccine, mNexspike, is a step towards next-generation coronavirus vaccines and is made with a lower dose, a fifth of the dose of Moderna's existing COVID-19 vaccine, Spikevax. The approval is for use in all adults 65 and older, and for people age 12 to 64 who have at least one health condition that puts them at increased risk from the coronavirus.

Key Takeaways:

  • The FDA approved Moderna's new COVID-19 vaccine, mNexspike, for use in all adults 65 and older and people age 12 to 64 with at least one health condition.
  • The new vaccine is made with a lower dose, a fifth of the dose of Moderna's existing COVID-19 vaccine, Spikevax.
  • The approval is based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine, finding the new vaccine to be safe and at least as effective as the original shot.
  • The moderna COVID-19 vaccine is not a replacement for the company's existing shot, but a second option.
  • The FDA's approval is a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials.
  • Moderna's existing vaccine doesn't face the same limits and has long been used for anyone ages 6 months and older.
  • The company expects to offer both options this fall.

Statistics:

  • 11,400: Number of people in the study that compared the new low-dose vaccine with Moderna's existing vaccine.
  • Ages 65 and older: Group that can use the new Moderna vaccine, mNexspike.
  • Ages 12 to 64 with at least one health condition: Group that can use the new Moderna vaccine, mNexspike.
  • 20%: Reduction in dose of the new Moderna vaccine, mNexspike, compared to the existing vaccine, Spikevax.
  • 2025: Copyright year of The Associated Press article.

Sources:

  • The Associated Press.
  • The Howard Hughes Medical Institute's Science and Educational Media Group.
  • The Robert Wood Johnson Foundation.

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