June 12 (Reuters) - The U.S. Food and Drug
Administration on Thursday expanded the use of Moderna's ( MRNA )
respiratory syncytial virus vaccine to a lower group of
adults aged 18 to 59 years at increased risk for disease.
Moderna's ( MRNA ) RSV shot, mRESVIA, was the first non-COVID-19
messenger RNA-based (mRNA) vaccine to be approved in the United
States. The shot, the company's second product, is already
approved for the prevention of RSV-associated lower respiratory
tract disease in adults aged 60 or older.
While the FDA approval is a necessary step, the U.S. Centers
for Disease Control and Prevention still has to recommend the
shots before they are available for the age group.
The CDC currently recommends the vaccine for adults aged 75
and older, as well as for adults aged 60 to 74 who are at
increased risk of infection.
In April, the CDC's panel of outside experts recommended the
use of approved RSV vaccines in at-risk adults aged 50 to 59.
Health Secretary Robert F. Kennedy Jr. on Wednesday named
eight new members to serve on the key panel of vaccine advisers,
known as the Advisory Committee on Immunization Practices, after
previously firing all 17 of its members, saying it would
"re-establish public confidence in vaccine science."
However, public health experts warn that this could
undermine public confidence in available vaccines.
Some of the new appointees have openly expressed
anti-vaccine views, including against the mRNA vaccine
technology.
The panel, which provides guidance to the CDC on which
groups of people would most benefit from an already-approved
vaccine, is scheduled to meet later this month.
RSV typically causes cold-like symptoms, but is also a
leading cause of pneumonia in toddlers and older adults. The CDC
estimates 15,000-20,000 annual RSV-associated hospitalizations
in the U.S. in adults aged 50 to 59.
The FDA's approval for mRESVIA was based on results from a
late-stage trial where the shot helped initiate significant
immune responses in adults aged 18 to 59 years with underlying
health conditions.
The vaccine was well-tolerated with no safety concerns, the
company said.
The FDA approved mRESVIA in adults aged 60 or older last
year, but with a lower efficacy label indicating the shot was
79% effective at preventing at least two symptoms of RSV, such
as cough and fever. Moderna ( MRNA ) had said the shot was shown to be
83.7% effective in a late-stage trial.
All currently approved shots against RSV, including Pfizer's ( PFE )
Abrysvo and GSK's Arexvy, are for adults aged 60
years and above.
Arexvy and Abrysvo are also approved to prevent
RSV-associated disease in at-risk adults aged 50 to 59 and 18 to
59, respectively.