Merck Statement regarding Role of PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) in Updated ACIP Recommendations for Pneumococcal Vaccination in Adults
WHITEHOUSE STATION, N.J., Aug 13, 2014 (BUSINESS WIRE) -- Merck MRK +1.47% , known as MSD outside of 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 pneumococcal vaccine recommendations for adults 65 years of age and older. These recommendations call for a two vaccine regimen utilizing a dose of the pneumococcal conjugate vaccine followed by a dose of Merck's PNEUMOVAX® 23, at an interval to be determined by the ACIP, in adults 65 years of age and older who have not previously received pneumococcal vaccine. ACIP also voted that these recommendations for routine use of the pneumococcal conjugate vaccine in adults 65 years of age and older should be reevaluated in 2018 and revised as needed. ACIP will continue to monitor disease trends and the impact of these new recommendations.
"We are pleased PNEUMOVAX 23 will continue to play an integral role in helping to prevent pneumococcal disease in adults who are at increased risk," said Mark Feinberg, MD, PhD, FACP, Chief Public Health and Science Officer for Merck Vaccines. "Pneumococcal disease is still a significant burden and millions of adults remain at risk because of low vaccination rates. It is also important for health care providers to fully implement the long-standing ACIP recommendation for use of only PNEUMOVAX 23 in adults 19 to 64 years of age with certain chronic conditions, such as diabetes and chronic heart disease, who are also at increased risk of pneumococcal disease."
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 (pneumococcal vaccine polyvalent) is approved for use in persons 50 years of age or older and persons 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.
Do not administer PNEUMOVAX 23 to individuals with a history of hypersensitivity reaction to any component of the vaccine.
Vaccination Rates among Adults Remain Low
According to the National Foundation for Infectious Diseases, approximately 73 million adults in the United States have an indication for pneumococcal vaccination, but have not been vaccinated. It has been estimated that about 59 million working-age (18 to 64 years of age) adults at increased risk for invasive pneumococcal disease remained unvaccinated in 2009. However, vaccination rates have remained low at 20 percent in this population, according to the CDC's National Health Interview Survey in 2012. This vaccination rate is well below the Healthy People 2020 goals, which call for a pneumococcal disease vaccination rate of 60 percent for high-risk people between the ages of 18 and 64 years. Moreover, pneumococcal vaccination rates among adults aged 65 years of age or older also remained low at only 59.9 percent in 2012, versus the Healthy People 2020 target of 90 percent.
More about PNEUMOVAX 23
Many different serotypes put patients at risk of developing pneumococcal disease. The 23 serotypes included in PNEUMOVAX 23 accounted for 76 percent and 66 percent of invasive pneumococcal disease among adults 50 years to 64 years of age and 65 years of age or older, respectively, according to 2008 CDC epidemiological data.
In clinical trials, PNEUMOVAX 23 has demonstrated a 57 percent overall reduction of invasive pneumococcal disease caused by the serotypes included in the vaccine and 65 to 84 percent effectiveness among a range of specific patient groups, including those with select chronic health conditions such as diabetes, chronic lung disease, or chronic heart disease, or those aged 65 years or older.
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 could pose a significant risk.
The most common adverse reactions, reported in more than 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.
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.
Vaccination with PNEUMOVAX 23 may not offer 100 percent protection from pneumococcal infection.
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 .
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's patents and other protections for innovative products; 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 2013 Annual Report on Form 10-K and the company's other filings with the SEC available at the SEC's Internet site ( www.sec.gov ).
Please see Prescribing Information for PNEUMOVAX 23 at http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf and Patient Information for PNEUMOVAX 23 at http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_ppi.pdf .
PNEUMOVAX ® 23 is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., USA
Pamela Eisele, 267-305-3558
Skip Irvine, 215-652-6059
Justin Holko, 908-423-5088
Copyright Business Wire 2014