A federal advisory committee today unanimously voted to endorse Moderna’s mRNA flu vaccine — just months after rejecting the company’s application on the basis that Moderna had not performed an “adequate and well-controlled” clinical trial.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC), which reviews scientific data on the safety and effectiveness of vaccines and other therapeutics on behalf of the U.S. Food and Drug Administration (FDA), voted 9-0 in dual votes to recommend approval of the vaccine for the 50-64 and 65-plus age groups.
Today’s votes took place after several hours of presentations based on the findings of Moderna’s Phase 4 clinical trial data for its mRNA-1010 vaccine. The trial compared the efficacy of mRNA-1010 to that of a conventional, non-mRNA flu vaccine.
Daniel O’Connor, founder and CEO of TrialSite News, told The Defender today’s favorable votes “may reflect the committee’s view that the benefit-risk profile is acceptable.” However, the vote “does not erase the fundamental concerns surrounding this application.”
“Significant questions remain about comparator selection, study design and whether the reported efficacy advantage represents a clinically meaningful improvement for patients or simply a statistical advantage within the framework of the trial,” O’Connor said.
According to an FDA briefing document prepared in advance of today’s meeting, “no major deficiencies were identified” with the vaccine for adults 50 and over. Citing the clinical trial data, the document states that the mRNA-1010 vaccine had a 26.6% relative efficacy rate in adults 50 and over, with similar rates for adults 65 and up.
The mRNA-1010 vaccine also showed a higher immune response than Sanofi’s Fluzone vaccine, the document noted. According to Fierce Biotech, these results met all of the FDA’s “pre-specified criteria for success” and bolstered Moderna’s application for approval.
Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense, said today’s vote shifts mRNA-1010 safety monitoring to after licensure.
“VRBPAC meetings proceed to the beat of the rubber stamp. The unanimous vote guarantees a lot of really good questions of harm will have to be answered in the post-marketing period, when that harm manifests in the population,” Jablonowski said.
Moderna seeks traditional approval for the mRNA-1010 vaccine for the 50-64 age group and accelerated approval for the 65-plus age group.
Fierce Biotech reported that the FDA uses VRBPAC meetings to “seek outside counsel on tough or high-profile regulatory decisions.”
The FDA will make an approval decision on mRNA-1010 by Aug. 5 — and while the agency is not bound to VRBPAC’s votes, it “often follows the opinions” of its advisory committees.
Moderna’s stock was up over 4% in trading immediately after the vote, and up 3.50% at the close of market.
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