Pfizer reported detailed findings Wednesday at the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) from the previously announced CAPiTA trial showing that Prevenar 13 (pneumococcal 13-valent conjugate vaccine) met primary and secondary endpoints by reducing first episodes of several kinds of community-acquired pneumonia (CAP) in older adults. The drugmaker noted that the study was the "first in adults to clearly demonstrate a significant reduction in vaccine-type pneumococcal CAP, and importantly, non-bacteraemic/non-invasive vaccine-type pneumococcal CAP."
The study involved approximately 85 000 patients aged 65 years and older who were randomised to receive a single dose of either Prevenar 13 or placebo. Regarding the study's primary objective, Pfizer reported that the Prevenar 13 arm had 45.56 percent fewer first episodes of vaccine-type CAP than the placebo group. With regard to the secondary endpoints, results showed that Prevenar 13-vaccinated subjects experienced 45 percent fewer first episodes of non-bacteraemic/non-invasive vaccine-type CAP and 75 percent fewer first episodes of vaccine-type invasive pneumococcal disease (IPD) than individuals in the placebo arm. The company added that the reductions in the risk of vaccine-type CAP, non-bacteraemic/non-invasive vaccine-type CAP and vaccine-type IPD persisted for up to four years after vaccination among those given Prevenar 13.
Further, Pfizer indicated that the safety profile of Prevenar 13 in the CAPiTA trial was consistent with studies previously conducted in adults. Emilio Emini, the company's senior vice president of Vaccine Research and Development, remarked that "evidence from this study is particularly important for a population in which age-related decline of the immune system makes it difficult to prevent disease."
Prevenar 13 was initially cleared by European regulators in 2009 for use in infants and young children to prevent invasive pneumococcal disease, as well as pneumonia and otitis media caused by 13 pneumococcal serotypes. Use of the vaccine in the EU has since been expanded to protect against invasive disease in patients of all ages, including most recently adults aged 18 to 49. The vaccine is currently approved for use in multiple countries, including the US, where it is marketed under the brand name Prevnar 13, for the prevention of pneumococcal disease and otitis media in very young children, as well as to prevent infections caused by pneumococcal bacteria among children and adolescents aged 6 to 17, and to immunise older adults aged 50 or more against pneumonia and invasive disease caused by Streptococcus pneumoniae.
For related analysis on the vaccine, read ViewPoints: Pfizer banking on M&A asset Prevnar to help drive split aspirations.
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