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 In clinical trials, GSK's Shingrix has shown greater protection for
older recipients than what has been demonstrated by Merck & Co's
rival Zostavax vaccine. The drug is one of GSK's biggest new product
hopes. It plans to file for U.S., European and Japanese approval
this year, and the vaccine could reach the market in 2017.
The latest four-year data on Shingrix, which appears in the New
England Journal of Medicine, shows it may also provide an additional
significant advantage by maintaining its effectiveness over time.
"It's a real step forward for vaccinology for elderly patients," the
study's lead author, Dr. Anthony Cunningham of the Westmead
Institute for Medical Research in Australia, said in a telephone
interview.
Zostavax efficacy declines with age, dropping to only about 18
percent in adults over 79 versus 70 percent for people in their 50s.
A Kaiser Permanente study found it was 69 percent effective in
patients age 60 and older, yet only 4.2 percent remained protected
seven years later.
Researchers found no such drop with GSK's vaccine in the study of
13,900 volunteers over age 69.
"Although the follow-up period was limited to four years, there was
little decline in effectiveness in the years following vaccination,"
said Dr. Susan Rehm, vice chairwoman of the department of infectious
disease at the Cleveland Clinic, who was not involved in the study.
GSK had previously reported 90 percent protection with Shingrix in
recipients over age 69.
It worked as well among people in their 70s as it did in people in
their 80s and 90s, and that effectiveness "was maintained for the
duration of the trial," said Dr. Kathleen Neuzil of the University
of Maryland School of Medicine and Dr. Marie Griffin of Vanderbilt
University Medical Center, in a Journal editorial.
It also protected against residual pain caused by shingles in 89
percent of cases.
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The risk of shingles, which is caused by reactivation of the chicken
pox virus, increases with age. There are about 1 million cases of
shingles in the United States each year, according to the Centers
for Disease Control and Prevention.
Analysts are forecasting global Shingrix sales reaching $1.2 billion
in 2021, according to Thomson Reuters Cortellis. The vaccine
contains a component from U.S. biotech Agenus Inc, which is entitled
to royalties on future sales, but no live virus.
The GSK vaccine was administered in two doses given two months
apart, while Merck's is given in one injection.
Nearly 80 percent of those who received Shingrix had a reaction to
the shot, such as arm soreness, including 12 percent whose reaction
was serious enough to prevent normal activity. That compared with
rates of 30 percent and 2 percent for those who received a placebo.
(Reporting by Gene Emery in Cranston, Rhode Island; Additional
reporting by Ben Hirschler in London; Editing by Bill Berkrot and
Matthew Lewis)
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