FDA Expands Indication for Zostavax, Merck's Shingles Vaccine, to Include Adults Ages 50 to 59

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Mar 24, 2011 - Merck, 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 vaccine recipients.

"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 MerckVaccines.com.

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 a contraindication.

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 recipients.

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 PNEUMOVAX 23 (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 untreated tuberculosis.

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 don't 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.

About Merck

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.

Forward-Looking Statement

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 forward-looking statements.

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

http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_pi.pdf and

http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_ppi.pdf and

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm136941.htm

ZOSTAVAX® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., USA

Contact: Merck
Media:
Pamela Eisele, 908-423-5042
or
Jennifer Allen Woodruff, 215-652-0572
or
Investors:
Carol Ferguson, 908-423-4465
or
Joe Romanelli, 908-423-5088

Posted: March 2011

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Zostavax (zoster vaccine live) FDA Approval History

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