Pfizer announced Monday that a study of Prevenar 13 (pneumococcal 13-valent conjugate vaccine) in adults 65 years of age and older met its main goal, as well as achieving both secondary objectives. William Gruber, senior vice president of Vaccine Clinical Research at the company, noted that the CAPiTA trial "demonstrated that Prevenar 13 can prevent vaccine-type pneumococcal community-acquired pneumonia in adults."
The study, which included around 85 000 patients in the Netherlands, had a primary endpoint of demonstrating the efficacy of Prevenar 13 against a first episode of vaccine-type community-acquired pneumonia (CAP). Meanwhile, the secondary goals were efficacy against a first episode of non-bacteraemic/non-invasive vaccine-type CAP and efficacy against a first episode of vaccine-type invasive pneumococcal disease. Pfizer said that detailed trial results will be presented next month at the International Symposium on Pneumococci and Pneumococcal Diseases.
The drugmaker noted that the CAPiTA study was conducted to verify the clinical benefit of Prevenar 13 in older adults after the agency granted accelerated approval for the vaccine in this population. Emilio A. Emini, senior vice president of Vaccine Research and Development at Pfizer, said the drugmaker will share the data "with US and worldwide regulatory authorities, and vaccine technical committees, to help inform decisions regarding potential Prevenar 13 label and recommendation updates."
ISI Group analyst Mark Schoenebaum suggested that the use of Prevenar 13 in adults is expected to contribute $1 billion to sales. Analysts predict that the product, which is known as Prevnar 13 in certain markets including the US, will generate overall revenue of $4.4 billion this year.
The vaccine, which was first cleared for use in infants and young children in December 2009 in Europe, is now approved for this indication in more than 120 countries, including the US and Japan. In addition, Prevenar 13 is authorised for use in adults 50 years of age and older in more than 90 countries, and is also cleared in the US and EU for use in older children and adolescents aged 6 to 17 years. Last year, Prevenar 13 was also approved in the EU for use in adults 18 to 49 years of age.
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