Surprising decision given RFK Jr.'s disdain and funding cuts for all mRNA vaccines
Moderna's
mFlusiva is the company's fourth mRNA-based product approved in the United
States, according to a Moderna press release. The vaccine has full approval for people 50 to
64 years of age. For those over 65, the FDA granted "accelerated
approval," which is temporary: Full approval depends on the long-term
safety and real-world effectiveness of the vaccine in this age group.
Earlier this
year, it seemed that the vaccine would never make it to market. The FDA refused to review Moderna's application, saying that
instead of comparing mFlusiva to the standard-dose seasonal influenza vaccine,
the company should instead have used the high-dose vaccine, which is
recommended for adults who are 65 and older. Also, Health Secretary Robert F.
Kennedy Jr. has questioned the safety of mRNA, which is the same technology
used to produce the COVID-19 vaccines.
However, a week
later, the FDA reversed its decision and agreed to review Moderna's
application after outcry from infectious disease experts and warnings that
outright refusal to review the application could cause a chilling effect that
would deter investments in new pharmaceuticals and dampen innovation.
"This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation," said Moderna CEO Stéphane Bancel, MBA.
Moderna said it
expects to have doses of mFlusiva available for this respiratory virus season.
Moderna's other mRNA vaccines are for respiratory syncytial virus and COVID-19,
including a COVID shot approved for infants as young as 6 months.
mRNA may be
key to a more efficacious flu vaccine
The FDA's
approval of mFlusiva is welcome news, as it provides another vaccine option to
help protect people from a virus that sends hundreds of thousands of Americans
to the hospital each year, said Ronald G. Nahass, MD, president of the
Infectious Diseases Society of America.
“Demonstrating
the success of mRNA for influenza opens the door to broader applications,
accelerating our ability to create safe and targeted vaccines for a wider range
of preventable diseases," Nahass said in a statement.
Flu vaccines made
with traditional methods require months of lead time. But the flu mutates
quickly, making it difficult to create a vaccine that's a good match for the
virus. Though the flu vaccine reduces the severity of illness, it's typically
less than 50% effective at preventing infection in a given year.
Manufacturing
mRNA vaccines is faster, so theoretically the flu vaccine can be updated as the
virus changes, giving hope that mFlusiva will prevent more severe illness and
death. The Centers for Disease Control and Prevention estimates
that 45,000 people
died of influenza during the 2024-25 flu season.
