2月24日，辉瑞宣布，Prevenar 13（肺炎链球菌13价结合疫苗）用于65岁及以上患者的一项临床研究达到了主要终点，同时也达到两项次要终点。该公司疫苗临床研究高级副总裁William Gruber指出，这项CAPiTA临床试验“证明Prevenar 13能够预防成人患者疫苗型肺炎链球菌社区获得性肺炎。”
这项研究在荷兰招募了大约8.5万名患者，其一项主要终点证明Prevenar 13对首次发病的疫苗型社区获得性肺炎(CAP)的有效性。同时，针对首次发病的非菌血症性/非侵袭性疫苗型CAP的次要目标是有效的，针对首次发病的疫苗型侵袭性肺炎链球菌疾病的次要目标是有效的。辉瑞表示，详细的临床试验结果下个月将在肺炎双球菌和肺炎球菌疾病国际研讨会上发布。
该制药商指出，FDA对Prevenar 13用于该类患者人群授予加速审批后，CAPiTA研究用来证明这款疫苗对老年患者的收益。辉瑞疫苗研发高级副总裁Emilio A. Emini表示，该制药商将“与美国及全球药品监管机构及疫苗技术委员会分享这项研究的数据，以帮助通知可能的Prevenar 13标签及使用建议更新决定。”
国际战略投资集团的分析师Mark Schoenebaum表明，Prevenar 13在成人患者中的应用预期将产生10亿美元的销售额。分析师们预测这款产品（在某些市场，包括美国被称作Prevnar 13）今年将实现44亿美元的总销售额。
这款疫苗于2009年首次在欧洲获批用于婴幼儿，目前在120多个国家被批准用于这种适应症，包括美国和日本。此外，Prevenar 13在90多个国家被授权用于50岁及以上成年人，在美国和欧洲也被批准用于更大年龄的儿童及6至17岁的青少年。去年，Prevenar 13在欧洲也被批准用于18至49岁成年人。
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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