Prescrire Int. 2004 Dec;13(74):206-8.
(1) Injectable influenza vaccines reduce morbidity and mortality in people over 65 years. (2) A new influenza vaccine, with an adjuvant (MF59C.1) based on squalene, is now marketed in France for people over 65, and especially those with chronic conditions at risk of influenza complications. (3) The clinical evaluation dossier contains data from about twenty immunogenicity studies in more than 4000 elderly subjects. According to a meta-analysis of these studies, there is no firm evidence that the MF59C.1 adjuvant vaccine is any better than other vaccines at inducing immunity in elderly people with chronic conditions. (4) A retrospective analysis of mortality among subjects enrolled in immunogenicity studies showed no significant difference between groups receiving the squalene adjuvant vaccine and groups receiving another influenza vaccine, either in the general population or in subsets of patients with relevant chronic conditions. (5) Local adverse effects (pain, rash, induration) and systemic adverse effects (malaise, myalgia, headache) were significantly more common after the squalene adjuvant vaccine than after other influenza vaccines. Pharmacovigilance data collected by the company show no unexpected adverse events. (6) In practice, there is no reason to prefer the squalene adjuvant vaccine to existing vaccines for elderly people, whether or not they have underlying chronic conditions.
(1) 注射用流感疫苗可降低65岁以上人群的发病率和死亡率。(2) 一种基于角鲨烯的新型流感疫苗（MF59C.1佐剂）目前在法国上市，适用于65岁以上人群，尤其是有流感并发症风险的慢性病患者。(3) 临床评估档案包含来自4000多名老年受试者的约二十项免疫原性研究的数据。根据对这些研究的荟萃分析，没有确凿证据表明MF59C.1佐剂疫苗在诱导患有慢性病的老年人产生免疫方面比其他疫苗更好。(4) 对免疫原性研究中受试者死亡率的回顾性分析表明，在普通人群或患有相关慢性病的患者亚组中，接受角鲨烯佐剂疫苗的组与接受另一种流感疫苗的组之间没有显著差异。(5) 角鲨烯佐剂疫苗接种后的局部不良反应（疼痛、皮疹、硬结）和全身不良反应（不适、肌痛、头痛）明显比其他流感疫苗更常见。该公司收集的药物警戒数据显示没有意外不良事件。(6) 在实际应用中，无论老年人是否有潜在慢性病，都没有理由更倾向于使用角鲨烯佐剂疫苗而不是现有疫苗。
