Pfizer Announces Positive Study Results For Prevenar 13 For Pneumonia
By Cyndi Root
Pfizer Inc. announced in a press release that Prevnar 13 has achieved successful results in a large clinical study. The Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) included about 85,000 subjects and achieved its primary and secondary clinical objectives. Dr. Emilio A. Emini, Senior Vice President, Vaccine Research and Development at Pfizer, said, “Pneumococcal pneumonia is a significant cause of illness and death in adults around the world, and the potential to reduce the burden of this disease through direct vaccination of adults represents a meaningful public health benefit.”
Pneumococcal Disease
Pneumococcal disease is caused by Streptococcus pneumonia (S. pneumoniae bacteria). It is transmitted by respiratory droplets that pass from an infected person to another via close contact. People experience sudden onset fever, chest pain, cough, bloody spit, and fatigue. Elderly patients may have mental confusion and shortness of breath. All ages can contract the disease, but children and the elderly are more susceptible. The disease is resistant to therapies, so medical providers attempt to target treatment according to antimicrobial susceptibility. Common treatment agents include vancomycin, fluoroquinolone, and cephalosporin.
Prevenar 13
Prevenar 13 is a vaccine. It is approved for children six weeks through 17 years for the prevention of Streptococcus pneumonia (strains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The vaccine is also effective for adults. It is not completely effective and only protects against the designated pneumonia strains. Side effects include lung infections, changes in appetite, hives, fatigue, headache, and rash, among others. Prevenar 13 is approved in 120 countries and is one of the most widely used vaccines with over 640 million doses distributed.
CAPiTA
The FDA required that Pfizer conduct the CAPiTA study as part of the FDA’s accelerated approval program. The study was a double-blind, randomized, placebo-controlled trial in adults. Over 85,000 people over the age of 65 participated. Julius Clinical spearheaded the effort in conjunction with 58 medical centers. Pfizer states that primary and secondary endpoints were met, with good efficacy and safety results. Study results will be presented at the 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Hyderabad, India.