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October 8, 2013 7:30 am ET

Reinforces Need for Healthcare Professionals and Patients to Discuss Shingles

Flu is at the top of the list of diseases older adults plan to ask about, according to results from a new Harris Interactive consumer awareness survey, sponsored by Merck (NYSE: MRK), known as MSD outside the United States and Canada. Most (68 percent) of the more than 600 surveyed adults age 60 and older are at least somewhat likely to ask their healthcare professional (doctors or pharmacists) about preventing the flu this year, and are significantly more likely to ask about this than prevention of other potentially serious diseases like shingles.

The survey also revealed the importance of physicians and pharmacists in encouraging vaccination. The survey indicated that 79 percent of older adults would be at least somewhat likely to receive the shingles vaccine if it were recommended by their doctor or pharmacist. Adults aged 60-plus were 58 percent more likely to receive the shingles vaccine if recommended by their healthcare professional than to ask for the vaccine proactively (79 percent vs. 50 percent, respectively).

“It is important for people age 60 and older to get the shingles vaccine because it is the only way to help reduce the risk of getting shingles, but vaccination rates for shingles remain well below those for other adult vaccines against flu or pneumococcal disease,” said Eddy Bresnitz, M.D., executive director, Global Medical Affairs and Policy, Merck Vaccines Division. “The results from this poll are a clear call to action for health care providers. It is important that a conversation about shingles takes place with their patients, both about the disease and vaccination against it.”

Shingles, the common name for herpes zoster, is a disease caused by the same virus that causes chickenpox. Once a person has chickenpox, the virus never leaves the body.  At some point later in life, quite unexpectedly, this virus can reactivate and erupt as shingles — a red blistering rash that can be very painful.

Any person who has had chickenpox is at risk for developing shingles, and 98 percent of adults in the United States have had chickenpox. A person’s risk for shingles increases as they get older, even if they are healthy. Because the immune system can weaken as a person ages, it’s easier for shingles to break through the body’s defenses in older adults. There is no way to predict if or when someone will get shingles, or how severe the case will be. There are approximately 1 million cases of shingles each year in the United States, and the CDC estimates that 1 in 3 people will get shingles during their lifetime.

The shingles vaccine, ZOSTAVAX,^® is approved by the FDA for adults 50 and older to help prevent shingles (also known as zoster). The Centers for Disease Control and Prevention (CDC) recommends that adults 60 or older get vaccinated to help prevent shingles. In the United States, more than 16 million doses have been shipped since 2006. Ample doses are available for physicians and pharmacists to vaccinate and help protect the more than 80 percent of Americans aged 60 and over who remain unvaccinated.

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. ZOSTAVAX should not be used for prevention of primary varicella infection (chickenpox).

Select Safety Information for ZOSTAVAX

Vaccination with ZOSTAVAX does 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.

Availability of ZOSTAVAX

ZOSTAVAX is available across the country in many doctor’s offices and pharmacies, and 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 offer ZOSTAVAX.

Based on historical insurance coverage information, it is estimated that over 90 percent of people 60 and older in the United States who have private health insurance are in plans that have approved reimbursement of ZOSTAVAX, and 100 percent of Medicare Part D plans have ZOSTAVAX on formulary.  Whether a person has coverage, and the amount of reimbursement, depends on the person’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 a covered medical and pharmacy benefit for people 60 and older under TRICARE, the health plan for the U.S. Department of Defense Military Health System.

Additional Survey Results

The poll also suggests that personal knowledge of, or experience with, shingles may be a major driver in a consumer’s decision about whether to receive the shingles vaccine.  Adults aged 60-plus who reported being familiar with a friend or family member’s experience with shingles were more likely to feel shingles is “very” or “extremely” serious than those without friends or a family member who had shingles (65 percent vs. 47 percent, respectively).  In addition, more than half (53 percent) of those who knew someone who had shingles said they would be at least somewhat likely to ask their healthcare professional about shingles vaccination, more than the 43 percent of those without a friend or family member who had experienced shingles.

Additional key findings from the survey include:

• More than 25 percent believe they are at risk for developing shingles, as compared to arthritis (60 percent), heart disease/problems (49 percent), cancer (43 percent), stroke (43 percent), diabetes (35 percent), and Alzheimer’s (34 percent).
• While 41 percent of adults aged 60-plus are at least somewhat worried about their risk for shingles (vs. 47 percent worried about their risk for flu), they are 26 percent less likely to ask their healthcare professional about ways to help prevent shingles than ways to help prevent flu (50 percent shingles vs. 68 percent flu).
• While 41 percent (271/668) of adults aged 60-plus are at least somewhat worried about their risk for pneumonia, they are 21 percent less likely to ask their healthcare professional about ways to help prevent pneumonia than ways to help prevent flu (54 percent pneumonia vs. 68 percent flu).
• Despite being more likely to ask their healthcare professional about ways to help prevent influenza than about ways to help prevent pneumonia this year, respondents were almost twice as likely to report a perception of pneumonia as “extremely” or “very” serious than they were to report the same perception of flu (70 percent to 38 percent respectively).

Survey Methodology

This survey was conducted online by Harris Interactive in the United States on behalf of Merck from September 10-12, 2013 among 668 U.S. adults ages 60 and older. This survey is not based on a probability sample; therefore, no assessment of theoretical sampling error can be made.  For a full methodology, including weighting variables, please contact Pamela Eisele at Merck.

Select Safety Information for ZOSTAVAX^® (Zoster Vaccine Live)

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). 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.

Before administering ZOSTAVAX^® (Zoster Vaccine Live), please read the Prescribing Information. The Patient Information also is available.

About PNEUMOVAX^®23 (Pneumococcal Vaccine Polyvalent)

PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).  PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥ 2 years who are at increased risk for pneumococcal disease.

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Select Safety Information for PNEUMOVAX 23

Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 in clinical trials, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.

Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Before administering PNEUMOVAX^®23 (Pneumococcal Vaccine Polyvalent), please read the Prescribing Information. The Patient Information also is available.

About AFLURIA^® (Influenza Vaccine)

AFLURIA is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older.

Select Safety Information for AFLURIA

AFLURIA is contraindicated in individuals with known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.

Administration of CSL’s 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 to less than 9 years of age.

If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks.

If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.

Antibody responses in persons 65 years of age and older were lower after administration of AFLURIA as compared to younger adult subjects.

In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness and pain. The most common systemic adverse reactions observed were headache, malaise, and muscle aches.

In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness and pain.

Vaccination with AFLURIA may not protect all individuals.

Before administering AFLURIA^® (Influenza Vaccine), please read the Prescribing Information.

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 and connect with us on Twitter, Facebook and YouTube.

Merck 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. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck patents and other protections for innovative products; and the exposure to litigation, including patent 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 2012 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). 

ZOSTAVAX^® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.

PNEUMOVAX 23^® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.

AFLURIA^® is a registered trademark of CSL Limited.

Please see Prescribing Information for ZOSTAVAX at http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_pi.pdf  and Patient Product Information for ZOSTAVAX at http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_ppi.pdf.

 

Please see Prescribing Information for PNEUMOVAX 23 at http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf and Patient Product Information for PNEUMOVAX 23 at http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_ppi.pdf.

Please see Prescribing Information for AFLURIA at http://www.merck.com/product/usa/pi_circulars/a/afluria/afluria_pi.pdf.

 

 

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