FDA's approval of new mRNA vaccine does not necessarily signal the government's embrace of the technology, experts say

The U.S. Food and Drug Administration (FDA) has approved an mRNA vaccine for seasonal influenza, a process that had been fraught with delays and controversy. This approval comes despite the federal government's past skepticism towards mRNA vaccines, with the Department of Health and Human Services (HHS) cutting funds for their development and a vaccine advisory committee being reshaped to favor those opposed to mRNA technology.

Health Secretary Robert F. Kennedy Jr. has even described mRNA vaccines as "the deadliest vaccines ever made."

Despite these tensions, the FDA's approval of the new flu vaccine, called mFlusiva, developed by Moderna, suggests that the agency's approval process is still functional. Jeff Coller, a distinguished professor of RNA biology and therapeutics at Johns Hopkins University, commented that this approval shows the statutory machinery still works when permitted to operate.

He believes that what the approval truly indicates is the resilience of the FDA's processes, rather than a shift in the administration's stance on mRNA vaccines.

The approval process for mFlusiva faced significant hurdles. Initially, the FDA denied Moderna's request for its materials to be reviewed, a decision later attributed to Dr. Vinay Prasad, then director of the Center for Biologics Evaluation and Research (CBER). After this denial, the process took a drastic turn when Prasad was replaced, and the FDA's vaccine advisory committee voted unanimously to recommend the vaccine's approval for adults aged 50 and above. The FDA followed this recommendation, making the vaccine officially available.

Now that mFlusiva is approved, the next step involves the Centers for Disease Control and Prevention (CDC) reviewing the data and issuing recommendations on how the vaccine should be distributed and to whom. However, this part of the process is currently uncertain due to ongoing litigation against the ACIP, which has caused a freeze on recent changes, including recent appointments by Robert F. Kennedy Jr. and a major revision of the childhood immunization schedule.

While the CDC could still issue its own recommendations without ACIP's involvement, it remains unclear if this will happen. The approval of mFlusiva could still be beneficial for the upcoming flu season, as trials suggest it offers more protection than existing options, particularly for adults aged 50 to 64.