The FDA has approved a new COVID-19 vaccine from Moderna, but it is only approved for use in people at high risk. The decision coincides with a controversial rollback of childhood vaccine recommendations under Health Secretary Robert F. Kennedy Jr.
The U.S. Food and Drug Administration has granted approval for Moderna's new low-dose COVID-19 vaccine, mNexspike. However, this approval comes with specific restrictions, confining its use to older adults and individuals with particular health conditions.
The new mNexspike vaccine distinguishes itself from Moderna’s widely used Spikevax by utilizing only one-fifth of the original dose, achieved through a refinement of its immune target. The FDA has approved the vaccine for adults aged 65 and older, as well as for individuals between the ages of 12 and 64 who have underlying health conditions. This decision mirrors the guidelines set for the recently authorized Novavax vaccine.
Moderna CEO Stéphane Bancel stated on Saturday, “This approval adds an important new tool to help protect people at high risk of severe disease.”
The FDA has announced its decision following a comprehensive trial involving 11,400 participants. The results indicate that the new vaccine is not only safe but also demonstrates effectiveness that is at least comparable to, if not superior to, the original Spikevax.
The decision represents a notable change in the vaccine policy of the United States. Moderna’s original vaccine continues to be accessible for individuals aged 6 months and older.
However, recent policy adjustments implemented by Health Secretary Robert F. Kennedy Jr. indicate a shift towards a more restrictive approach. The Centers for Disease Control and Prevention (CDC) announced on Thursday that it has rescinded its universal COVID-19 vaccine recommendation for children. The agency now recommends the vaccine primarily for immunocompromised children and the majority of adults.
Kennedy’s directive highlighted a lack of adequate data regarding the safety of mRNA vaccines in healthy children and pregnant women, asserting that the potential risks surpass the benefits for these populations.
Concerns have been raised by critics within the federal health community. “This would be akin to the secretary of transportation issuing a directive that all planes must operate at an altitude 5,000 feet higher than the current standard.” “It’s vibe-based decision making,” stated an anonymous health official.
In a significant move, the Trump administration recently announced the cancellation of funding for Moderna’s research into a pandemic flu vaccine. This decision includes the cessation of efforts related to a potential H5N1 bird flu vaccine, despite the promising results observed in early trials.
