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Executive Summary

PNEUMOCOCCAL PNEUMONIA VACCINE "WIDER USE" SUPPORTED by results of a surveillance study published Nov. 21 in (ITALICS)The New England Journal of Medicine.(END ITALICS) "The estimates of the efficacy and effectiveness of pneumococcal vaccine in this and previous studies are within the range that has been considered necessary for a public health strategy of widespread immunization of persons at high risk to be cost effective," the authors concluded. The study was funded by grants from the National Institute on Aging and by Lederle, which manufactures (ITALICS)Pnu-Imune 23.(END ITALICS) Merck also manufactures a pneumococcal vaccine, (ITALICS)Pneumovax 23.(END ITALICS) One of the lead researchers, Robert Austrian, PhD, disclosed owning stock in both American Cyanamid (Lederle) and Merck. In the study, "The Protective Efficacy of Polyvalent Pneumococcal Polysaccharide Vaccine," Yale University School of Medicine's Eugene Shapiro, MD, (ITALICS)et al.(END ITALICS) describe a case-control study of 1,054 patients eligible for the vaccine who were hospitalized for a pneumococcal infection in 11 Connecticut hospitals. Each prospectively identified case patient was matched to a control based on age, hospitalization site, time of hospitalization and indication for use of vaccine. The researchers noted that the vaccine was used in only 13% of the case patients and 20% of matched controls. The vaccine was 61% effective among "immunocompetent patients" who were indicated for use of the vaccine because of age (over 55), pulmonary disease, alcoholism, heart failure or diabetes, the researchers said. In "immunocompromised patients," the vaccine did not show a statistically significant efficacy. The researchers determined an overall effectiveness of the vaccine of 47%. The efficacy of the vaccine against the 23 serotypes included in the vaccine (out of 84 known (ITALICS)Streptococcus pneumoniae(END ITALICS) serotypes) was 56%. The article notes that 93% of the case patients were infected with serotypes included in the vaccine and that, as expected, the vaccine had no protective effect for patients infected by other serotypes. Pneumococcal vaccines have been licensed in the U.S. since 1977, Shapiro (ITALICS)et al.(END ITALICS) noted. "Subsequently, reports of vaccine failure and surveillance data from the Centers for Disease Control led to uncertainty about the vaccine's efficacy in some target populations in the U.S." "This study provides compelling evidence that polyvalent pneumococcal vaccine is effective in preventing invasive pneumococcal infections in immunocompetent patients with indications for receiving the vaccine," the researchers concluded. "Perhaps the greatest challenge is to ensure that health care providers use pneumococcal vaccine. Although it is relatively inexpensive and serious adverse reactions are rare, only 20% of the controls in this study (all of whom had one or more indications for vaccination) had received the vaccine." In the accompanying editorial, CDC's Claire Broome, MD, and Robert Breiman, MD, echoed the article's conclusions. Noting that "the Immunization Practices Advisory Committee of the Public Health Service recommends that the pneumococcal vaccine be administered to all persons 65 years of age or older," they ask: "What can be done to increase the use of this safe vaccine, which can prevent a potentially fatal disease?" The editorial suggests that "incentives such as enhanced reimbursement may encourage hospitals to establish" policies to target patients for the vaccine. Broome, chief of the Division of Bacterial Diseases' Meningitis and Special Pathogens Branch at CDC, is also a member of FDA's Vaccines & Related Biologicals Advisory Committee. Noting that there have been recent outbreaks of pneumococcal infections in prisons, military camps and boarding houses, Broome and Breiman ask: "Is it time to reconsider whether the pneumococcal vaccine should be routinely administered to persons in large, crowded institutional settings with frequent turnover?" The editorial concludes: "Physicians and public health practitioners should unite in an attempt to ensure the full use of this vaccine in appropriate groups."

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