The Food and Drug Administration decision makes GSK’s shot,
called Arexvy, the first of several potential vaccines in the pipeline for RSV
to be licensed anywhere.
The move sets the stage for adults 60 and older to get
vaccinated this fall — but first, the Centers for Disease Control and
Prevention must decide if every senior really needs RSV protection or only
those considered at high risk from the respiratory syncytial virus. CDC’s
advisers will debate that question in June.
After decades of failure in the quest for an RSV vaccine,
doctors are anxious to finally have something to offer — especially after a
virus surge that strained hospitals last fall.
“This is a great first step ... to protect older persons
from serious RSV disease,” said Dr. William Schaffner, medical director of the
National Foundation for Infectious Diseases, who wasn’t involved with its
development. Next, “we’re going to be working our way down the age ladder” for
what’s expected to be a string of new protections.
The FDA is considering competitor Pfizer’s similar vaccine
for older adults. Pfizer also is seeking approval to vaccinate pregnant women,
so their babies are born with some of mom’s protection.
There isn’t a vaccine for kids yet but high-risk infants
often get monthly doses of a protective drug during RSV season — and European
regulators recently approved the first one-dose option. The FDA also is
considering whether to approve Sanofi and AstraZeneca’s one-shot medicine.
“This is a very exciting time with multiple potential RSV
solutions coming out after years of really nothing,” said Dr. Phil Dormitzer,
chief of vaccine research and development for GSK, formerly known as
GlaxoSmithKline.
RSV is a cold-like nuisance for most people but it can be
life-threatening for the very young, the elderly and people with certain
high-risk health problems. It can impede babies’ breathing by inflaming their
tiny airways, or creep deep into seniors’ lungs to cause pneumonia.
In the U.S., about 58,000 children younger than 5 are
hospitalized for RSV each year and several hundred die. Among older adults, as
many as 177,000 are hospitalized with RSV and up to 14,000 die annually.
Why has it taken so long to come up with a vaccine? The
field suffered a major setback in the 1960s when an experimental shot worsened
infections in children. Scientists finally figured out a better way to develop
these vaccines — although modern candidates still were first tested with
adults.
GSK’s new vaccine for older adults trains the immune system
to recognize a protein on RSV’s surface, and contains an ingredient called an
adjuvant to further rev up that immune reaction.
In an international study of about 25,000 people 60 and
older, one dose of the vaccine was nearly 83% effective at preventing RSV lung
infections, and reduced the risk of severe infections by 94%.
To see how long protection lasts, GSK is tracking study
participants for three years, comparing some who get just one vaccination
during that time and others given a yearly booster.
Shot reactions were typical of vaccinations, such as muscle
pain and fatigue.
There was a hint of a rare but serious risk — one case of
Guillain-Barre syndrome, which can cause usually temporary paralysis, and two
cases of a type of brain and spinal cord inflammation. The FDA said it was
requiring the company to continue studying if there really is a link to the
vaccine.
If the CDC ultimately recommends the vaccination for some or
even all seniors, it will add another shot for the fall along with their yearly
flu vaccine – and maybe another COVID-19 booster.
“We’ll have to educate the population that this virus that
not everyone has heard about is actually an important threat to their health in
the wintertime,” said Schaffner, an infectious disease expert at Vanderbilt
University
.The Associated Press Health and Science Department receives
support from the Howard Hughes Medical Institute’s Science and Educational
Media Group. The AP is solely responsible for all content. -AP
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