Department of Health Sciences, University of Genoa, Via A. Pastore 1, 16132 Genoa, Italy.
Expert Rev Vaccines. 2012 Jan;11(1):17-25. doi: 10.1586/erv.11.154.
On May 9 2011, the US FDA approved Sanofi Pasteur's Fluzone(®) Intradermal influenza vaccine, the first influenza vaccine licensed in the USA that uses a new microinjection system for intradermal delivery of vaccines (Soluvia™, Becton Dickinson). Its antigen content is lower (9 µg hemagglutinin per strain) than the conventional intramuscular vaccine (15 µg) and it is indicated for active immunization of adults aged between 18 and 64 years. Data from the clinical trial assessing immunogenicity and safety of Fluzone Intradermal in adults were consistent with substantial experience accumulated with Intanza(®) 9 µg, the intradermal vaccine licensed on February 26 2009 and launched during the 2010/2011 season in Europe. Fluzone Intradermal is safe and its immunogenicity comparable with that of conventional intramuscular vaccines. Obtaining optimal acceptability of intradermal vaccines may represent an additional asset to help increase the coverage of influenza vaccination in young adults.
2011 年 5 月 9 日,美国食品药品监督管理局批准赛诺菲巴斯德的 Fluzone(®)皮内用流感疫苗,这是美国首个获准使用新型微注射系统皮内接种疫苗的流感疫苗(Soluvia™,BD)。其抗原含量低于传统的肌肉内用疫苗(15µg),适用于 18 至 64 岁成人的主动免疫。评估 Fluzone 皮内用在成人中的免疫原性和安全性的临床试验数据与 2009 年 2 月 26 日获准上市、2010/2011 年流感季节在欧洲推出的 Intanza(®)9µg皮内用疫苗积累的大量经验一致。Fluzone 皮内用是安全的,其免疫原性与传统的肌肉内用疫苗相当。获得皮内用疫苗的最佳可接受性可能是增加年轻人流感疫苗接种覆盖率的一个额外优势。