FDA Authorizes New Moderna COVID-19 Vaccine: mNexspike

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01/06/2025 19h24

### FDA Approves New Moderna COVID-19 Vaccine with Use Restrictions

The U.S. Food and Drug Administration (FDA) has authorized a new COVID-19 vaccine developed by Moderna. This new immunization, known as mNexspike, will not replace the company's existing Spikevax vaccine but will serve as an additional option. Unlike its predecessor, mNexspike requires only a fifth of the dose by honing in on a more targeted immune response.

"The approval of this new vaccine adds an important tool to protect individuals at high risk of severe COVID-19," said Stephane Bancel, Moderna's CEO, in a statement released on Saturday.

The FDA’s approval applies to all adults aged 65 and over, as well as individuals aged 12 to 64 who have at least one health condition that increases their risk from the virus. These restrictions mirror the conditions set on another COVID-19 vaccine produced by Novavax.

This approach deviates from previous U.S. policies regarding COVID-19 vaccines, which reflects a broader skepticism fueled by health officials including Robert F. Kennedy Jr. and other members of the Trump administration. Moderna's existing vaccine remains available for anyone six months or older, and the company plans to offer both vaccines this fall.

The FDA’s decision was based on a clinical trial involving 11,400 participants aged 12 and above. This study compared the new low-dose mNexspike vaccine with Moderna’s original Spikevax, concluding that it is safe and at least as effective, if not more, in some measures.

In related news, the Trump administration recently cut funding for Moderna's separate project aimed at developing a vaccine for potential pandemic flu viruses, including the H5N1 bird flu, despite promising preliminary results.

The Associated Press Health and Science Department, backed by the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation, reported on these developments. However, the AP maintains full editorial control over its news content.

The views expressed in this article do not reflect the opinion of ICARO, or any of its affiliates.

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