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继南美两项试验失败后,美国国立卫生研究院和Wyeth-Ayerst药厂研制的口服轮状病毒疫苗证明在发展中国家可能有效.2207名委内瑞拉婴儿分别于2、3、4月龄时接种3剂四价恒河猴疫苗(每剂含4万蚀斑形成单位)或安慰剂.疫苗可减少严重轮状病毒腹泻88%、脱水75%和住院70%.疫苗还可预防48%的轮状病毒腹泻初次发作.但该疫苗首剂口服后有15%婴儿发热,而安慰剂组只有7%.根据上述结果以及芬兰2398名婴儿研究的肯定结果,美国食品和药物管理局(FDA)咨询委员会计划于12月初开会决定是否推荐该疫苗获取批准,Wyeth药厂已于今年初向FDA提出该疫苗的生产许可申请.
Oral rotavirus vaccine developed by the National Institutes of Health and Wyeth-Ayerst Pharmaceuticals may prove effective in developing countries following the failure of two South American trials.2207 Venezuelan infants were vaccinated at 2, 3, and 4 months of age respectively Vaccine reduces the incidence of severe rotavirus diarrhea by 88%, dehydration by 75%, and hospitalization by 70%. The vaccine also prevented 48% of the rotations The initial episode of viral diarrhea was 15% of the infants after the first oral dose of the vaccine, compared with 7% in the placebo group.Based on the above results and the positive findings of 2398 infants in Finland, the FDA Advisory Committee It is planned that a meeting will be held in early December to decide whether the vaccine should be approved for approval. Wyeth Pharmaceuticals filed an application for the vaccine with the FDA earlier this year.