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Merck Issues Statement Related to Role of PNEUMOVAX 23 in Updated ACIP Recommendations

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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.

Posted-In: News FDA Press Releases


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