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).
PNEUMOVAX 23™ is a trademark of Merck & Co., Inc.,
Whitehouse Station, NJ, USA
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.
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