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Merck Statement on CDC Advisory Committee on Immunization Practices' Recommendation for Pneumococcal Vaccination in Immunocompromised Adults

WHITEHOUSE STATION, N.J., June 20, 2012 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today provided the following statement regarding the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP)'s updated recommendation for pneumococcal vaccine as a two vaccine regimen in adults with immunocompromising conditions, functional or anatomic asplenia, cerebral spinal fluid (CSF) leaks or cochlear implants.

“Merck supports today's ACIP recommendation for the use of PNEUMOVAX 23 as part of the regimen in these individuals," said Mark Feinberg, M.D., Ph.D., chief public health and science officer, Merck Vaccines. "In addition to this updated recommendation, it is important for clinicians to continue to focus on implementing the ACIP's long-standing recommendation for use of only PNEUMOVAX 23 to help protect all adults aged 65 and older, as well as adults 19 and older with certain other chronic medical conditions, such as diabetes and COPD."

PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) 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) and is approved for use in people 50 years of age or older and people aged two years and older 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.

PNEUMOVAX 23 is not to be administered to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

At today's meeting, the CDC also released epidemiological data on pneumococcal disease in adults with immunocompromising conditions. These data show that the 11 unique serotypes covered in PNEUMOVAX 23 accounted for 21 percent of invasive pneumococcal disease in these individuals and the 23 serotypes collectively accounted for more than 70 percent of disease. PNEUMOVAX 23 is the only vaccine available in the United States indicated to prevent pneumococcal disease caused by 23 serotypes of pneumococcal bacteria.

According to the CDC’s 2010 Adult NHIS (National Health Interview Survey), at least one third of people aged 65 years and older have not received the recommended dose of PNEUMOVAX 23, and at least 80 percent of the ACIP-recommended 19-64 age at-risk population has not been vaccinated, indicating a need to continue to improve vaccination coverage in these individuals.

Select Safety Information about PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent)
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.

The most common adverse reactions, reported in >10 percent 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.

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished response to PNEUMOVAX 23.

PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.

Routine revaccination of immunocompetent persons previously vaccinated with a PNEUMOVAX 23 is not recommended.

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

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.

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 all of 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 in the United States and internationally; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; 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 2011 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).

 

Posted: June 2012


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