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Pfizer Announces Positive Top-Line Results Of Landmark Community- Acquired Pneumonia Immunization Trial In Adults (CAPiTA) Evaluating Efficacy of PCV 13

April 29, 2014 – Pfizer Inc. made a global announcement that the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects evaluating the efficacy of (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults 65 years of age and older, achieved both it’s primary and secondary clinical objectives. CAPiTA is the largest double-blind, randomized Placebo-controlled vaccine efficacy trial ever conducted in adults.

The primary objective of the study was to demonstrate efficacy of
PCV 13 vaccine against a first episode of vaccine-type community acquired pneumonia (CAP). The CAPiTA study also met both secondary objectives, which were efficacy against (i) a first episode of non-bacteremic/non-invasive vaccine-type CAP and (ii) a first episode of vaccine-type invasive pneumococcal disease
(IPD).

“I am delighted to learn about the results of one of the most comprehensive trials ever done in the history of vaccines. As is evident, the outcome is very positive. Pneumonia is one of the biggest public health concerns in Pakistan and it is fortunate that an effective pneumococcal conjugate vaccine protecting against 13 serotypes of pneumococcal bacteria is currently available and approved for use worldwide. We have witnessed this vaccine decreasing the disease burden in children and now we are encouraged that it will also protect adults and elderly people from pneumococcal disease and its deadly complications.” said Dr. Prof. Sajid Maqbool, leading Infectious Disease expert.  

The trial results are expected to change the way we look at adult pneumococcal vaccination and is a major breakthrough in this therapeutic area. Commenting on the Pfizer’s commitment to bring innovative treatments to Pakistan, Country Manager, Dr. Farid Khan said, “Pfizer Pakistan has always been at the forefront in providing treatments for various infectious diseases including vaccine that provides broad protection against Pneumococcal Diseases and this landmark trial is a proof that the vaccine is effective in providing immunity and efficacy against the Primary and Secondary Clinical Objectives in achieving the desired results. PCV 13 is effective in providing immunity to the adult segment of the society.”


The CAPiTA data will be an important component for potential, new or updated PCV 13 recommendations for adults. In addition, other key factors will be taken into consideration, such as the current burden of pneumococcal disease in adults.

PCV 13 was licensed by the US FDA under an accelerated approval process to address an unmet medical need in older adults. As a requirement of this accelerated approval pathway, Pfizer conducted CAPiTA to verify clinical benefits.

The last week of April is celebrated as the World Immunization Week, marking the importance of vaccination and prevention of disease globally.

 

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