Shingles Seen as Possible Trigger for Cardiovascular Events
C.D.C. Panel Recommends a New Shingles Vaccine
WASHINGTON
— In an unusually close vote, an advisory panel to the Centers for
Disease Control and Prevention on Wednesday recommended the use of a new
vaccine to prevent shingles over an older one that was considered less
effective.
The
decision was made just days after the Food and Drug Administration
announced approval of the new vaccine, called Shingrix and manufactured
by GlaxoSmithKline, for adults ages 50 and older. The panel’s
recommendation gives preference to the new vaccine over Merck’s
Zostavax, which has been the only shingles vaccine on the market for
over a decade and was recommended for people ages 60 and older.
The
Advisory Committee on Immunization Practices also recommended that
adults who have received the older vaccine get the new one. Even with
the committee vote, this recommendation still awaits formal endorsement
by the head of the C.D.C., which usually takes a couple of months.
Insurance companies must also agree to cover the cost of the vaccine,
which GSK estimates to be $280 for two doses.
According
to the C.D.C., almost one of every three people in the United States
will contract shingles, a viral infection that can result in a painful
rash and lasting nerve damage.
The
disease, also known as herpes zoster, can range in severity from barely
noticeable to debilitating. It is caused by the varicella-zoster virus,
which also causes chickenpox.
Once
a person has had chickenpox, the virus lies inactive in nerve tissue.
Years later, it may reactivate as shingles. The C.D.C. estimates that
about one million cases are diagnosed in the United States each year.
“This
is what we’ve been waiting for,” said Dr. Anne Louise Oaklander, an
associate professor of neurology at Harvard Medical School and an expert
in the disease. “Shingles is an unappreciated and common cause of
severe problems throughout the nervous system.”
Dr.
Oaklander said that while rash symptoms lead some people to consider
shingles as minor as a bad sunburn, the illness can cause strokes,
encephalitis, spinal cord damage and loss of vision.
Given
in one dose, Zostavax had shown a 51 percent reduction in shingles and a
67 percent reduction in nerve pain. Shingrix is given in two doses, and
the company said clinical trials showed it to be about 98 percent
effective for one year and about 85 percent over three years.
By
preventing shingles, the vaccine also drastically reduces the overall
incidence of severe nerve pain, a lasting complication for about one in
three people who get shingles. GlaxoSmithKline said it tested the
vaccine in more than 38,000 people.
“We
believe Shingrix will provide confidence in the protection one can
expect from a shingles vaccine,” said Luc Debruyne, the company’s
president of global vaccines.
The
recommendation of the advisory committee will be considered an
endorsement of Shingrix over Zostavax, although the closeness of the
committee vote, 8 to 7, may mitigate the market loss for Merck.
Dr.
Kathleen Dooling, a medical officer in the C.D.C.’s division of viral
disease, said she expected the agency’s final recommendation to be
issued early next year.
“The
Shingrix vaccine has the potential to prevent tens of thousands of
cases of shingles and its complications,” Dr. Dooling said.
She cautioned, however, that more people had adverse reactions to Shingrix than to Zostavax, including fever and muscle aches.
“Patients
and health care providers should be aware that this vaccine is very
effective, but it also causes more reactions than they may be used to
with other adult vaccines,” she said. “All indications are these are not
dangerous to one’s health, but they may interfere with your daily
activities for a few days.”
GlaxoSmithKline said its new vaccine would cost about $280 and would be available next month. Zostavax costs about $223.
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