US Approves New COVID-19 Vaccine with Limited Use
The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company’s existing shot, but a second option.
The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It’s made in a way that allows for a lower dose — a fifth of the dose of its current COVID-19 vaccine, Spikevax — by refining its immune target.
What the Approval Means
The approval “adds an important new tool to help protect people at high risk of severe disease from COVID-19,” Stephane Bancel, Moderna’s CEO, said in a statement Saturday.
The Food and Drug Administration approved the new vaccine 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.
Eligibility and Restrictions
That’s the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax.
Those restrictions are 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.
Moderna’s existing vaccine doesn’t face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall.
Study Results and Effectiveness
The FDA’s approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna’s existing vaccine. It found the new vaccine was safe and was at least as effective — and more by some measures — than the original shot, the company said.
Recent Developments
The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results.
Conclusion
In conclusion, the approval of the new COVID-19 vaccine by Moderna is a significant step towards protecting people at high risk of severe disease from COVID-19. The vaccine has shown to be safe and effective, and its lower dose makes it a more appealing option for some individuals. However, the restrictions on its use and the skepticism surrounding vaccines may impact its adoption.
FAQs
Q: What is the name of the new COVID-19 vaccine approved by the FDA?
A: The new COVID-19 vaccine is called mNexspike.
Q: Who is eligible to receive the new vaccine?
A: The vaccine is approved 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.
Q: How does the new vaccine differ from Moderna’s existing vaccine?
A: The new vaccine has a lower dose — a fifth of the dose of Moderna’s existing vaccine, Spikevax — and is made in a way that allows for a more refined immune target.
Q: Is the new vaccine a replacement for Moderna’s existing vaccine?
A: No, the new vaccine is not a replacement for Moderna’s existing vaccine, but rather a second option.
