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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
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
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
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
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. 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
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