WHITEHOUSE STATION, N.J.(BUSINESS WIRE)
Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Food and Drug Administration (FDA) has
approved an expanded age indication for ZOSTAVAX (Zoster
Vaccine Live) for the prevention of herpes zoster, commonly known as
shingles, in adults 50 years of age and older. In a large clinical
study, ZOSTAVAX significantly reduced the risk of developing shingles by
nearly 70 percent in adults ages 50 to 59, compared with placebo.
ZOSTAVAX is the only shingles vaccine licensed for use in the U.S.
According to the U.S. Centers for Disease Control and Prevention (CDC),
in the U.S. approximately 1 in 3 people will experience shingles in
their lifetime and nearly one million cases of shingles occur each year.
The incidence and severity of shingles increase with age. Once a person
has had chickenpox the varicella-zoster virus (VZV) stays inside the
body and can resurface later as shingles.
This expanded indication is important for the health of people who are
50 and older because nearly everyone in that age group is at risk for
developing shingles," said Jeffrey Silber, M.D., vice president, Merck
Research Laboratories. ZOSTAVAX can help to prevent this disease that
can be painful and potentially debilitating for some people."
ZOSTAVAX is not indicated for the treatment of shingles or postherpetic
neuralgia (PHN) or for the prevention of chickenpox. ZOSTAVAX is
contraindicated for individuals who are allergic to any of its
ingredients, including gelatin or neomycin, have a weakened immune
system, take high doses of steroids, or are pregnant or plan to become
pregnant. Vaccination with ZOSTAVAX may not result in protection of all
"Merck is investing more than $1 billion to enhance manufacturing so
that as many people as possible may have access to ZOSTAVAX and our
other varicella-containing vaccines," said Julie L. Gerberding, M.D.,
president, Merck Vaccines. "Merck remains committed to this important
vaccine and to our customers who continue to support ZOSTAVAX and the
critical role of adult vaccination in public health."
Supply of ZOSTAVAX (Zoster Vaccine Live)
Customers can order ZOSTAVAX, but the product is currently on backorder.
Merck will continue to release doses of ZOSTAVAX as supply becomes
available, but as inventory is building, backorders will still occur.
Timely information about the shipping times for ZOSTAVAX can be found at
Consumers and healthcare providers can visit www.zostavax.com
to search an online database called the "Directory to Find ZOSTAVAX" to
obtain a list of physician offices or pharmacies within their selected
area that make ZOSTAVAX available and that may have supply in stock.
People using this directory are encouraged to contact the locations
directly to determine whether they currently have product available.
FDA approval first step to increasing access to ZOSTAVAX for adults
50 to 59
The CDC currently recommends a single dose of ZOSTAVAX for all
appropriate people 60 years of age and older, regardless of whether they
have had a prior case of shingles, noting that persons with chronic
medical conditions may be vaccinated unless their condition constitutes
Following FDA approval the next step is a vote by the CDC's Advisory
Committee on Immunization Practices (ACIP) on whether to recommend
administration of ZOSTAVAX for use in people ages 50 to 59. Merck
anticipates that the ACIP will vote on use of ZOSTAVAX in this
population later this year. Some managed care companies may decide to
provide reimbursement for ZOSTAVAX for adults ages 50 to 59 prior to the
ACIP's vote; however, many insurance companies typically await the
ACIP's vote before making a coverage determination.
Broad managed care coverage for ZOSTAVAX for adults 60 and older
Based on historical coverage information, Merck estimates that over 90
percent of people 60 and older in the U.S. who have private health
insurance are in plans that have approved reimbursement of ZOSTAVAX, and
Medicare Part D plans covering over 90 percent of Part D enrollees in
the U.S. have included ZOSTAVAX on formulary. Whether a patient has
coverage, and the amount of reimbursement, depends on the patient's
benefit design, including any applicable co-pays, coverage limitations,
co-insurance and/or deductibles and the reimbursement rate adopted by
each plan. ZOSTAVAX is also a covered medical benefit for people 60 and
older under the U.S. Veterans Health Administration and TRICARE, the
health plan for the U.S. Department of Defense Military Health System.
ZOSTAVAX (Zoster Vaccine Line) significantly reduced the incidence of
shingles by nearly 70 percent in adults ages 50 to 59
In Merck's ZOSTAVAX Efficacy and Safety Trial (ZEST), a randomized,
double-blind, placebo-controlled study in adults who were 50 to 59 years
of age at the time of vaccination, 11,184 volunteers received ZOSTAVAX
and 11,212 received placebo. Study participants were monitored for the
development of shingles for a median of 1.3 years (range 0 to 2 years)
after receiving vaccination. Participants also were followed for adverse
events (AEs) for 42 days postvaccination and for serious adverse events
(SAEs) through six months postvaccination.
In this study, 30 cases of shingles occurred in the vaccine group versus
99 cases of shingles in the placebo group: efficacy of the vaccine was
69.8 percent (95 percent Confidence Interval [CI]: 54.1 percent, 80.6
percent), which met the study's pre-specified criterion for success.
Varicella-zoster virus antibody levels (Geometric Mean Titers, GMT), as
measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) six
weeks after vaccination, were increased 2.3-fold (95 percent CI: 2.2
percent, 2.4 percent) in the group of subjects who received ZOSTAVAX
compared to subjects who received placebo, meeting the pre-specified
success criterion for this endpoint.
There was an overall higher incidence of AEs in the vaccine group versus
the placebo group; this difference was primarily due to different rates
of injection-site AEs (63.6 percent for vaccine vs. 14.0 percent for
placebo). The overall incidence of systemic adverse experiences reported
within 42 days of vaccination was higher for ZOSTAVAX than for placebo
(35.4 percent for vaccine vs. 33.5 percent for placebo); however, no
significant differences were observed between the two study groups for
any individual systemic AEs with the exception of pain in the extremity
and headache. Serious adverse events (SAE) occurred at a similar rate in
subjects vaccinated with ZOSTAVAX or placebo within 42 days of
vaccination (0.6 percent for vaccine vs. 0.5 percent for placebo) and
182 days of vaccination (2.1 percent for vaccine vs. 1.9 percent for
placebo). An anaphylactic reaction was reported for one study
participant who received ZOSTAVAX.
About ZOSTAVAX (Zoster Vaccine Live)
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of
herpes zoster (shingles) in individuals 50 years of age and older.
ZOSTAVAX is not indicated for the treatment of zoster or postherpetic
neuralgia (PHN). ZOSTAVAX should not be used for prevention of primary
varicella infection (Chickenpox).
Select safety information
Vaccination with ZOSTAVAX may not result in protection of all vaccine
ZOSTAVAX is contraindicated in: persons with a history of anaphylactic
or anaphylactoid reaction to gelatin, neomycin, or any other component
of the vaccine; persons with a history of primary or acquired
immunodeficiencies; persons on immunosuppressive therapy; pregnant women
or women of childbearing age.
A reduced immune response to ZOSTAVAX was observed in individuals who
received concurrent administration of PNEUMOVAX23
(Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals
who received these vaccines 4 weeks apart. Consider administration of
the two vaccines separated by at least 4 weeks.
Serious vaccine-related adverse reactions that have occurred following
vaccination with ZOSTAVAX include asthma exacerbation and
polymyalgia rheumatica. Other serious adverse events reported following
vaccination with ZOSTAVAX include cardiovascular events (congestive
heart failure, pulmonary edema). The rate of serious adverse reactions
from Days 0 to 42 postvaccination may be increased. Common adverse
reactions occurring in ?1% of vaccinated individuals during clinical
trials include injection-site reactions (erythema, pain/tenderness,
swelling, hematoma, pruritus, warmth) and headache.
Transmission of vaccine virus may occur between vaccinees and
susceptible contacts. Deferral should be considered in acute illness
(for example, in the presence of fever) or in patients with active
Shingles is a painful disease that can be debilitating
Shingles is marked by a blistering rash and is caused by the
reactivation of VZV, the same virus that causes chickenpox. After
someone has had chickenpox, the virus never leaves their body, remaining
inactive in certain nerve roots in the body for many years. If the virus
becomes active again usually later in life it causes shingles.
The first signs of shingles are often felt and may not be seen, and can
include itching, tingling, or burning. Later, a painful rash of
fluid-filled blisters appears, usually on one side of the body or face.
The rash may take two to four weeks to heal, and the pain from the rash
can range from mild to severe.
Merck Vaccine Patient Assistance Program
For people who dont have insurance and meet other eligibility criteria,
Merck makes ZOSTAVAX, and other Merck vaccines indicated for use in
appropriate people ages 19 and older, available free of charge through
the Merck Vaccine Patient Assistance Program. More information on the
Merck Vaccine Patient Assistance Program can be found at www.merckhelps.com
or by calling 1-800-293-3881.
Today's Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For
more information, visit www.merck.com.
This news release includes forward-looking statements? within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. Such statements may include,
but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and
operating results, the combined company's plans, objectives,
expectations and intentions and other statements that are not historical
facts. Such statements are based upon the current beliefs and
expectations of Merck's management and are subject to significant risks
and uncertainties. Actual results may differ from those set forth in the
The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that the expected synergies from the merger of Merck and
Schering-Plough will not be realized, or will not be realized within the
expected time period; the impact of pharmaceutical industry regulation
and health care legislation; the risk that the businesses will not be
integrated successfully; disruption from the merger making it more
difficult to maintain business and operational relationships; Merck's
ability to accurately predict future market conditions; dependence on
the effectiveness of Merck's patents and other protections for
innovative products; the risk of new and changing regulation and health
policies in the U.S. and internationally and the exposure to litigation
and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck's 2010 Annual Report on Form 10-K and the company's other
filings with the Securities and Exchange Commission (SEC) available at
the SEC's Internet site (www.sec.gov).
Prescribing information and patient product information for ZOSTAVAX
*(Zoster Vaccine Live) are available at
ZOSTAVAX is a registered trademark of Merck
& Co., Inc., Whitehouse Station, N.J., USA
Pamela Eisele, 908-423-5042
Allen Woodruff, 215-652-0572
Joe Romanelli, 908-423-5088