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FDA Panel Says Shingles Vaccine Zostavax Okay for
Senior Citizens
Data does not support use for Baby Boomers
Dec. 18, 2005 – A panel of the U.S. Food and Drug
Administration has determined the vaccine Zostavax, made by Merck & Co.,
is safe for senior citizens 60 and over to use for preventing shingles.
The extremely painful condition is estimated to strike about half of all
seniors by the time they reach age 85.
The FDA Vaccines and Related Biological Products
Advisory Committee agreed that the extensive data from clinical trials
in more than 40,000 people support the efficacy and safety of Zostavax
for these older people but said the data was not sufficient to support
the safe use of the vaccine for those aged 50 to 59.
The Advisory Committee also suggested areas for
additional analysis. Merck plans to work with the FDA on these analyses
as well as the design of Merck's already planned post-licensure studies.
The FDA is not bound by the committee's
recommendation but takes its advice into consideration when reviewing
investigational vaccines.
"Shingles can be a very painful disease that can
lead to serious and long-lasting complications," said Peter S. Kim,
Ph.D., president, Merck Research Laboratories. "We are pleased with
today's outcome and look forward to working with the FDA as it continues
its review of our application for this vaccine."
The company filed a Biologics License Application (BLA)
with the FDA on April 25 for ZOSTAVAX to reduce the risk of shingles; to
reduce the risk of postherpetic neuralgia, the persistent, often
debilitating long-term nerve pain that is the most common complication
of shingles; and to reduce the total burden of pain and discomfort
caused by shingles.
In addition to the U.S. regulatory application,
Merck has filed regulatory applications for ZOSTAVAX in several other
world markets including the European Union, Canada and Australia.
Merck presented data from several studies conducted
in more than 40,000 people, including data from the Phase III Shingles
Prevention Study (SPS) of 38,500 adults age 60 and over. The SPS was a
Department of Veterans Affairs (VA) study conducted in collaboration
with the National Institute of Allergy and Infectious Diseases (NIAID)
at the National Institutes of Health (NIH) and Merck at 22 U.S. research
sites over a period of five years. Results from the SPS were published
in the June 2 issue of The New England Journal of Medicine.
About Shingles and Postherpetic Neuralgia
Shingles is caused by the reactivation of latent
varicella zoster virus - the same virus that causes chickenpox. Shingles
may first appear as abnormal skin sensations ranging from itching or
tingling to severe pain on a single area of the body or face.
It then usually progresses to a rash and
fluid-filled blisters accompanied by pain in almost every case. The
pain varies in intensity and duration.
Shingles also can lead to severe complications,
including long-term nerve pain (postherpetic neuralgia) that can follow
an episode of shingles. This complication can last for months or even
years after the rash has healed and can range from a tender, burning
pain to a throbbing, stabbing pain.
Shingles can affect anyone who has had chickenpox
-- more than 90 percent of adults in the United States -- and occurs
most frequently in older adults.
In fact, it is estimated that up to half of all
people who reach age 85 will have developed shingles during their
lifetime. A recent study estimated that up to 1 million cases of
shingles occur every year in the United States. The number of shingles
cases is expected to increase as the population ages.
Zostavax is one of three late-stage investigational
vaccines at Merck. Yesterday, the same FDA Advisory Committee agreed
that the clinical data supported the efficacy and safety of Rotateq, the
Company's investigational vaccine to protect against rotavirus
gastroenteritis. On Dec. 1, the Company submitted to the FDA its BLA
for Gardasil, the Company's investigational cervical cancer vaccine.
About Merck
Merck & Co., Inc. is a global research-driven
pharmaceutical company dedicated to putting patients first. Established
in 1891, Merck currently discovers, develops, manufactures and markets
vaccines and medicines to address unmet medical needs. The Company says
it devotes extensive efforts to increase access to medicines through
far-reaching programs that not only donate Merck medicines but help
deliver them to the people who need them. Merck also publishes
"unbiased" health information as a not-for-profit service. For more
information, visit
www.merck.com.
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