Field Epidemiology Training Program, Health Surveillance Secretariat, Ministry of Health, Brasília, Brazil.
Vaccine. 2013 Jan 30;31(6):950-4. doi: 10.1016/j.vaccine.2012.11.095. Epub 2012 Dec 13.
During Brazil's national measles, mumps, and rubella (MMR) vaccination campaign in August 2004, an unexpectedly high rate of hypersensitivity-type adverse events (HAEs) was reported.
We reviewed information about children with suspected HAEs reported by clinicians to Brazil's national passive surveillance system for adverse events following immunization (AEFI), compared attack rate of HAE by manufacturer of MMR vaccine used in the campaign, and conducted a case-control study to determine possible risk factors for HAEs.
During the 2004 national campaign, the rate of HAEs following MMR vaccination was one log higher for manufacturer A (15.2/100,000 doses administered) compared to the other two manufacturers (1.2 and 0.6/100,000 doses; p<0.0001); a similar pattern was observed retrospectively in analysis of the 2000-2003 AEFI surveillance (0.95 vs. 0.07 per 100,000 doses administered; p<0.0001). In the case-control study, among the 49 case-patients with HAEs identified, reported symptoms included conjunctival injection (60%), urticaria (55%), fever (54%), and facial edema (53%); no deaths occurred. The median time interval between vaccination and symptom onset was 42min (range: 5min-24h). We did not identify any differences in the proportion of case-patients and control children with a history of known allergy to food (including egg, egg-containing products or gelatin), drugs, or environmental antigens.
Our study highlights the importance of a well-functioning routine AEFI surveillance system linked with mass vaccination campaigns. Such a system in Brazil permitted timely detection of HAEs and validation of a safety signal associated with one vaccine manufacturer. Unlike earlier publications, this outbreak linked to a single manufacturer of MMR showed no association with a prior allergic history to eggs or other foods, including gelatin; subsequent studies implicate the dextran stabilizer in MMR from manufacturer A as the likely cause of HAEs.
2004 年 8 月，巴西全国开展麻疹、腮腺炎和风疹（MMR）疫苗接种运动期间，报告了异常高比例的过敏型不良反应（HAE）。
我们复习了临床医生向巴西全国免疫接种后不良反应被动监测系统报告的疑似 HAE 患儿信息，比较了疫苗接种运动中使用的 MMR 疫苗制造商的 HAE 发病率，并进行了病例对照研究，以确定 HAE 的可能危险因素。
在 2004 年全国运动期间，与其他两家制造商（每 10 万剂接种 1.2 和 0.6 剂）相比，制造商 A 的 MMR 疫苗接种后 HAE 发生率高出一个对数级（15.2/10 万剂；p<0.0001）；在对 2000-2003 年 AEFI 监测的回顾性分析中观察到类似模式（每 10 万剂接种 0.95 与 0.07 剂；p<0.0001）。在病例对照研究中，在确定的 49 例 HAE 病例患者中，报告的症状包括结膜充血（60%）、荨麻疹（55%）、发热（54%）和面部水肿（53%）；没有死亡发生。接种和症状出现之间的中位时间间隔为 42min（范围：5min-24h）。我们没有发现病例患者和对照儿童中，对食物（包括鸡蛋、含鸡蛋产品或明胶）、药物或环境抗原有已知过敏史的比例有任何差异。
我们的研究强调了与大规模疫苗接种运动相关的常规 AEFI 监测系统的重要性。巴西的这种系统允许及时发现 HAE，并验证与一家疫苗制造商相关的安全性信号。与之前的出版物不同，此次与 MMR 的单一制造商相关的暴发与鸡蛋或其他食物（包括明胶）的既往过敏史无关；随后的研究表明，来自制造商 A 的 MMR 中的葡聚糖稳定剂可能是 HAE 的原因。
