欧盟批准辉瑞肺炎疫苗Prevenar 13（沛儿13）用于18岁及以上成人群体

辉瑞（Pfizer）重磅疫苗产品Prevenar 13（沛儿13）近日在欧盟监管方面收获大好消息。欧盟委员会（EC）已批准扩大Prevenar 13适应症，用于18岁及以上成人群体，预防由13种血清型肺炎链球菌株导致的肺炎。Prevenar 13的产品特性概要（SPC）也已更新，纳入了辉瑞具有里程碑意义的CAPiTA（社区获得性肺炎成人免疫试验）研究的疗效数据，表明接种Prevenar 13显著降低了65岁及以上成人群体中疫苗型社区获得性肺炎（CAP）的首次流性发作，包括非侵入性/非菌血症性CAP和侵入性肺炎球菌病（IPD）。

Prevenar 13在一些国家被称为沛儿13，是全世界使用最广泛的肺炎球菌结合疫苗（PCV），累计疫苗接种已超过7.5亿个剂量，该产品也是全世界最畅销的疫苗，2014年的全球销售额高达45亿美元，是辉瑞的第2号旗舰产品。目前，Prevenar 13已获全球120多个国家批准。

CAPiTA（成人社区获得性肺炎免疫试验）研究是迄今为止在老年群体中开展的史上最大的双盲随机安慰剂对照疫苗疗效研究，涉及约8.5万名65岁及以上受试者。研究数据表明，与安慰剂组相比，Prevenar 13免疫组疫苗型CAP首次发作减少45.56%（p=0.0006）、非菌血症性/非侵入性疫苗型肺炎球菌CAP首次发作减少45.00%（p=0.0067）、疫苗型IPD首次发作减少75.00%。该项研究中Prevenar 13的安全性与既往研究一致。其他数据还显示，接种Prevenar 13的受试者，在免疫之后长达4年的时间内，疫苗型CAP、非菌血症性/非侵入性疫苗型CAP、疫苗型IPD首次发作均减少。该研究是首次在成人群体中明确证明疫苗型肺炎球菌CAP流性发作显著降低的研究，更重要的是，显著降低了非菌血症性/非侵入性疫苗型肺炎球菌CAP的流性发作。

Prevenar 13（沛儿13）是由辉瑞开发的一款13价肺炎链球菌结合型疫苗，是目前唯一一种获FDA和欧盟批准用于全年龄段（从婴儿期至成年期）的肺炎球菌疫苗，用于预防13株肺炎链球菌菌株（1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,23F）导致的肺炎球菌性肺炎和侵入性疾病。

Prevenar 13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。此外，Prevenar13在90多个国家被加速批准用于50岁及以上成年人，以解决老年群体中的医疗需求。作为加速审批的要求，辉瑞开展了CAPiTA来验证Prevenar13的临床利益。在美国和欧洲，Prevenar 13也被批准用于更大年龄的儿童及6至17岁的青少年。2013年，Prevenar13在欧洲也被批准用于18至49岁成年人。

英文原文：

Pfizer Receives European Approval for New Indication for Prevenar 13 for Prevention of Vaccine-Type Pneumococcal Pneumonia in Adults

Label Also Updated to Include Data From the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA)

Tuesday, March 3, 2015 - 8:35am
EST
Pfizer Inc. (NYSE:PFE) announced today that the European Commission approved an expanded indication for the use of Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from Pfizer’s landmark Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia (CAP), including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease (IPD) in adults aged 65 and older.

“We welcome the approval of this new indication for Prevenar 13 in the EU, which will enable healthcare professionals to help adults reduce their risk of pneumococcal pneumonia caused by the 13 serotypes in the vaccine. This is particularly important for older adults and those with medical conditions that may make them more vulnerable to this serious, debilitating and potentially deadly disease,” said Rene Reinert, Vice President, Pfizer Vaccines Medical and Scientific Affairs, Europe. “Pfizer looks forward to working with vaccine technical committees in Europe to discuss this new indication and the CAPiTA data, as well as potential updates to recommendations for the use of Prevenar 13 in adults.”

Streptococcus pneumoniae, also known as pneumococcus, is the most common bacterial cause of community-acquired pneumonia.1Pneumococcal pneumonia is one of the leading causes of death and hospitalization worldwide.2,3 Pneumococcal pneumonia can be classified as non-invasive, when bacteria cause infection in the lungs but are not detected in the blood concurrently, or invasive, when bacteria also enter the bloodstream (bacteremic pneumonia) or another normally sterile site in the body.4 For every one case of invasive pneumococcal pneumonia in adults, it is estimated that at least three cases of non-invasive pneumococcal pneumonia occur.5 While non-invasive forms of pneumococcal disease are typically more common, the invasive types of disease are generally more severe.6

Pfizer conducted the CAPiTA study (Community-Acquired Pneumonia Immunization Trial in Adults) as part of its regulatory commitments to global regulatory authorities. The results have been submitted to the U.S. Food and Drug Administration and regulatory agencies in other major markets, including Australia and Canada, for inclusion in the product’s labeling.

About CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults)

This study is one of the largest double-blind, randomized, placebo-controlled vaccine efficacy trials ever conducted in older adults. The study achieved its primary and secondary objectives. It involved approximately 85,000 subjects aged 65 years and older and was conducted by Julius Clinical, an academic research organization affiliated with the University Medical Center Utrecht (UMCU) in the Netherlands. Fifty-nine sentinel hospitals were used for the surveillance of CAP and IPD.

About Prevenar 13

With this approval for Prevenar 13, it is now indicated in the EU for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly. Prevenar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide, including the United States and Japan. It is the most widely used pneumococcal conjugate vaccine (PCV) in the world, and more than 750 million doses of Prevenar 7-valent/Prevenar 13 have been distributed worldwide. In addition, Prevenar 13 is approved for use in adults 50 years of age and older in more than 90 countries, and is also approved in the United States, European Union (EU) and other countries for use in older children and adolescents aged 6 to 17 years.

INDICATIONS FOR PREVNAR 13®

Prevnar 13® is a vaccine approved in the U.S. for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). This indication is based upon immune responses to the vaccine
For children 6 weeks through 17 years of age, Prevnar 13® is approved in the U.S. for the prevention of invasive disease caused by the 13 vaccine strains, and for children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains
Prevnar 13® is not 100% effective and will only help protect against the 13 strains included in the vaccine
Effectiveness when given less than 5 years after a pneumococcal polysaccharide vaccine is not known