Merck (NYSE:MRK), 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.
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. 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
MerckMedia:Pamela Eisele, 267-305-3558Skip Irvine,
215-652-6059orInvestors:Justin Holko, 908-423-5088
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