Registration of influenza vaccines for children in Europe

被引:11
作者
Granstrom, Marta [1 ,2 ,3 ,4 ]
Voordouw, Albertha C. G. [4 ,5 ]
机构
[1] Karolinska Inst, Dept Microbiol Tumor & Cellbiol MTC, Stockholm, Sweden
[2] Karolinska Univ Hosp Solna, Stockholm, Sweden
[3] EMA, Paediat Comm, London E14 4HB, England
[4] EMA, Comm Med Prod Human Use CHMP, London E14 4HB, England
[5] Med Evaluat Board, The Hague, Netherlands
关键词
Influenza vaccines; Children; Efficacy; Serology; Correlates to protection; MICRONEUTRALIZATION TEST; NEUTRALIZING ANTIBODY; VIRUS; PROTECTION; INFECTION; VACCINATION; CHALLENGE; LIVE;
D O I
10.1016/j.vaccine.2011.08.017
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Current trivalent inactivated influenza vaccines (TIV) for seasonal use have all been licensed in the EU based on serological data only. European Medicines Agency (EMA) guidelines for development of influenza vaccines and acceptance criteria are in place for adults but not for children. The Paediatric Committee initiated a review of the literature on influenza vaccines for children, which led to the conclusion that for new influenza vaccines the Paediatric Investigation Plan (PIP) will need to include an efficacy trial. A review of the serological assays raised questions on the relevance of the current assays for children and on the methodological differences in the performance of the neutralisation test. The basis for the current correlate for immune protection is been discussed and the role of antibodies to the neuraminidase for protection against disease has increasingly been recognised. These considerations, together with the experiences gathered during the pandemic, resulted in an ongoing revision of the EMA guidelines for influenza vaccines to be replaced by a single guideline with the aim of having better characterised influenza vaccines that will also address the needs of children. (C) 2011 Elsevier Ltd. All rights reserved.
引用
收藏
页码:7572 / 7575
页数:4
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