Goes AGAINST Bobby Junior's war against mRNA vaccines
 |
| As a rule, vaccines only work if you take them. |
By a unanimous vote, the Food and Drug Administration’s
(FDA’s) Vaccines and Related Biological Products Advisory Committee (VRBPAC)
voted to recommend approval of the investigational vaccine, which will be
marketed under the brand name mFlusiva, for the prevention of flu in adults age
50 to 64.
They also voted in support of accelerated approval in adults
aged 65 and older. Moderna will be required to conduct a phase 4,
post-marketing study to demonstrate effectiveness in the older group.
The recommendation comes after several months of regulatory
uncertainty over the vaccine. After initially agreeing to review Moderna’s
application for approval of the vaccine, the FDA changed
course in February, saying that the phase 3 trial for mRNA-1010 was not
“adequate and well-controlled” because it used a standard-dose seasonal flu
vaccine as the comparator vaccine.
Moderna said that while
the FDA had expressed a preference to use a high-dose flu vaccine as a
comparator, agency officials had agreed that a standard-dose flu vaccine was an
acceptable comparator.
The move raised concerns about shifting regulatory standards
under the leadership of Health and Human Services Secretary Robert F. Kennedy
Jr., who has been openly critical of mRNA vaccines. In August 2025, Kennedy
canceled $500 million in funding for 22 mRNA vaccine projects.
But a week later, the FDA reversed
itself again after Moderna proposed a revised regulatory approach.
The agency agreed to review the application for full approval in adults age 50
to 64 and accelerated approval for adults aged 65 and older, with an agreement
to conduct a post-marketing study in the 65 and older group.
All nine members voted in favor of approval
The VRBPAC review focused on data from the phase 3 trial, which involved nearly
41,000 adults 50 years and older in 11 countries during the 2024-25 flu season.
The trial found mRNA-1010 provided significantly better protection against
flu-like illness than standard-dose shots, with a relative vaccine efficacy of
27%. Immunogenicity data indicated efficacy in the 65 and over group.
VRBPAC members were tasked with reviewing the data and
voting on two questions: Do the benefits of mFlusiva outweigh the risks for the
prevention of flu in adults aged 50 to 64, and do the benefits outweigh the
risks in adults aged 65 and older? For the second question, members had to
decide whether the immunogenicity results from the phase 3 trial provided a
reasonable basis to predict clinical benefit.
Although there were questions about the length of the trial
(which covered only one flu season), the lack of data in immunocompromised and
very frail older adults, and more reactogenicity events (primarily fever) in
those who received mRNA-1010, all nine panel members voted yes on both
questions.
“I do believe the data presented support that the benefits
of the vaccine in both age groups outweigh the risks,” said VRBPAC member Flor
Munoz-Rivas, MD, an expert in pediatric infectious disease at Baylor College of
Medicine.
Moderna officials hailed the recommendation.
“We believe mRNA-1010 has the potential to provide an
important new option for seasonal flu prevention and further demonstrate the
versatility of our mRNA platform,” Moderna CEO Stephane Bancel, MBA, MSc, said
in a company press release. “We
look forward to continuing to work with the FDA as it completes its
review."
Because mRNA-1010 uses mRNA technology instead of traditional egg-based methods, Moderna has suggested it could be updated more quickly to match circulating flu strains or a pandemic flu strain. Several VRBPAC members cited that as a potential benefit.
“This particular platform adds exciting ways that we can
actually move our vaccines to the future,” said Hayley Gans, MD, of Stanford
Medicine.
In a media briefing after the vote, members of Georgetown
University’s Expert Vaccine Analysis Team said they were happy that the FDA
changed course and agreed to review the vaccine and that the VRBPAC members
carefully and thoroughly weighed the risks and benefits of the vaccine before
voting to recommend approval.
“This is something that looks like it has considerable
promise in a number of ways, so I think it’s very important that there has been
a careful review and an open discussion,” said Jesse Goodman, MD, MPH, a
professor of medicine and infectious diseases at Georgetown and former director
of the FDA’s Center for Biologics Evaluation and Research.
The recommendation now heads to the FDA, which has said it
will make its decision by August 5.
