Updated: OCTOBER 20, 2017 — 6:53 PM EDT
GlaxoSmithKline’s shingles vaccine, Shingrix, has been approved
by the FDA to prevent the herpes zoster (shingles) virus in older adults.
GlaxoSmithKline’s
new shingles vaccine, Shingrix, was approved Friday by the Food and Drug
Administration, a potential $1 billion-a-year drug to prevent the shingles
virus in adults 50 and older.
“The
vaccine has shown over 90 percent efficacy across all age groups,” said Thomas
Breuer, senior vice president and chief medical officer of GSK vaccines.
“Shingrix represents a significant scientific advancement in the field of
vaccinology.”
The
final step will be for the Centers for Disease Control and Prevention’s
Advisory Committee on Immunization Practices to sign off for the use of
Shingrix at its meeting next Wednesday. Following that recommendation, Shingrix
would be available shortly, the company said.
GSK will
go head-to-head with rival Merck, which has the only other marketed shingles
vaccine, Zostavax.
The CDC
advisers next week may vote that Shingrix should be the preferred vaccine over
Merck’s shot. The GSK vaccine produces a stronger immune response and lasts
longer, with no major safety issues.
Data
reported in the New England Journal showed that in adults 70 and older, two
doses of the GSK vaccine had 90 percent protection compared with a placebo. The
effectiveness went down only slightly, to 88 percent, after four years.
By
contrast, Merck’s vaccine, according to a Kaiser Permanente study of adults 60
and older, decreased from 68.7 percent effectiveness initially to 4.2 percent
in the eighth year after vaccination.
“With
Merck’s Zostavax, you begin to lose protection even after the first year,” said
William Schaffner, professor of preventive medicine at Vanderbilt University
School of Medicine. “By the time you get out to year seven, many people are
down to their pre-immunization baseline again.”
“Zostavax
was shingles vaccine 1.0. Shingrix is shingles vaccine 2.0. It’s better,” noted
Schaffner, who said he has no financial ties to GSK or involvement in the
studies. Shingrix has been tested in more than 38,000 people, GSK said.
Based on
the efficacy and safety profile, and incidence of shingles — one in three
people develops the virus — life science analysis firm EvaluatePharma predicts
Shingrix will have blockbuster sales of $1.126 billion by 2022. Sales of
Merck’s Zostavax were $685 million last year.
Canada
this month became the first country to approve the vaccine for people 50
and older as a prevention against the painful rash caused by the reactivation
of the varicella zoster virus, the same virus that causes chickenpox.
People
who live to 85 have a 50-50 chance of developing shingles, which can result in
a complication called postherpetic neuralgia, a debilitating nerve pain. The
risk of shingles increases with age as the body’s immune system declines.
However,
there are a couple of issues with the GSK vaccine: It requires two shots, two
to six months apart. (The Merck vaccine is one shot.) And it’s “more ouchy” at
the time of injection, Schaffner said.
Insurance
companies usually cover what the CDC immunization committee recommends.
But for
people 65 and older on Medicare, the shingles vaccine is covered only under
Medicare Part D, the prescription drug benefit. As a result, only 31 percent of
people older than 65 have received Merck’s vaccine, “which is much less than it
ought to be,” Schaffner said. “Not every Medicare recipient elects a Part D
coverage.”
The CDC
advisers may also decide whether people who were previously vaccinated with
Merck’s vaccine can safely receive the Shingrix vaccine later, and when.
GSK
presented study results in June that 430 adults who received the Merck vaccine
five years earlier were revaccinated with GSK’s vaccine. They had no serious
side effects, and the immune response was strong, the company said.
http://www.philly.com/philly/business/new-glaxosmithkline-shingles-vaccine-gets-fda-approval-20171020.html
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