National Immunization Program, Chinese Center for Disease Control and Prevention, Beijing, China and.
World Health Organization Office in China, Beijing, China.
Int J Epidemiol. 2016 Apr;45(2):441-9. doi: 10.1093/ije/dyv349.
China reduced hepatitis B virus (HBV) infection by 90% among children under 5 years old with safe and effective hepatitis B vaccines (HepB). In December 2013, this success was threatened by widespread media reports of infant deaths following HepB administration. Seventeen deaths and one case of anaphylactic shock following HBV vaccination had been reported.
We conducted a telephone survey to measure parental confidence in HepB in eleven provinces at four points in time; reviewed maternal HBV status and use of HepB for newborns in birth hospitals in eight provinces before and after the event; and monitored coverage with hepatitis B vaccine and other programme vaccines in ten provinces.
HepB from the implicated company was suspended during the investigation, which showed that the deaths were not caused by HepB vaccination. Before the event, 85% respondents regarded domestic vaccines as safe, decreasing to 26.7% during the event. During the height of the crisis, 30% of parents reported being hesitant to vaccinate and 18.4% reported they would refuse HepB. Use of HepB in the monitored provinces decreased by 18.6%, from 53 653 doses the week before the event to 43 688 doses during the week that Biokangtai HepB was suspended. Use of HepB within the first day of life decreased by 10% among infants born to HBsAg-negative mothers, and by 6% among infants born to HBsAg-positive mothers. Vaccine refusal and HepB birth dose rates returned to baseline within 2 months; confidence increased, but remained below baseline.
The HBV vaccine event resulted in the suspension of a safe vaccine, which was associated with a decline of parental confidence, and refusal of vaccination. Suspension of a vaccine can lead to loss of confidence that is difficult to recover. Timely and credible investigation, accompanied by proactive outreach to stakeholders and the media, may help mitigate negative impact of future coincidental adverse events following immunization.
中国通过使用安全有效的乙型肝炎疫苗（乙肝疫苗），使 5 岁以下儿童的乙肝病毒（HBV）感染率降低了 90%。然而，2013 年 12 月，由于媒体广泛报道乙肝疫苗接种后婴儿死亡事件，这一成功受到了威胁。当时已经报告了 17 例死亡和 1 例接种乙肝疫苗后出现过敏休克的病例。
我们在 11 个省份的四个时间点进行了电话调查，以衡量父母对乙肝疫苗的信心；调查了 8 个省份的出生医院在事件发生前后产妇的乙肝病毒状况和新生儿使用乙肝疫苗的情况；并监测了 10 个省份的乙肝疫苗和其他疫苗的覆盖率。
在调查期间，涉事公司的乙肝疫苗被暂停使用，调查结果表明这些死亡并非由乙肝疫苗接种引起。事件发生前，85%的受访者认为国产疫苗是安全的，而在事件发生期间，这一比例降至 26.7%。在危机最严重的时候，30%的家长表示对接种犹豫不决，18.4%的家长表示他们将拒绝接种乙肝疫苗。在监测省份，乙肝疫苗的使用量下降了 18.6%，从事件发生前一周的 53653 剂降至 Biokangtai 乙肝疫苗暂停使用期间的 43688 剂。HBsAg 阴性母亲所生婴儿乙肝疫苗第一针的接种率下降了 10%，HBsAg 阳性母亲所生婴儿的接种率下降了 6%。在两个月内，疫苗拒绝率和乙肝疫苗基础免疫剂量率恢复到基线水平；信心有所增加，但仍低于基线水平。
乙肝疫苗事件导致安全疫苗被暂停使用，这导致了家长信心下降和疫苗接种拒绝。疫苗的暂停使用会导致信心的丧失，而这种信心的恢复是困难的。及时和可信的调查，以及对利益相关者和媒体的积极外联，可能有助于减轻未来偶发疫苗接种后不良反应事件的负面影响。
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