Chang Soju, Begier Elizabeth M, Schech Stephanie D, Venus Patricia, Shatin Deborah, Braun M Miles, Ball Robert
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 20852, USA.
Pediatr Infect Dis J. 2007 Apr;26(4):329-33. doi: 10.1097/01.inf.0000258616.12752.51.
From July to September 1999, due to a concern of toxicity from exposure to thimerosal-containing vaccines, the American Academy of Pediatrics and U.S. Public Health Service temporarily recommended delaying the administration of first dose of hepatitis B vaccine until the age of 2-6 months for infants born to hepatitis B surface antigen negative mothers. Our objectives were to determine whether the recommendation affected the rate of perinatal hepatitis B infection in a multistate managed care population; to describe neonatal and early childhood cases of hepatitis B infection and to evaluate a possible role of the recommendation; and to assess the timeliness, with respect to the U.S. childhood immunization schedule, of vaccinations during the first 2 years of life.
We identified 3 cohorts of infants born before (July 1998 to June 1999), during (July 1999 to September 1999) and after (October 1999 to September 2000) the recommendation period. We used automated claims data to identify possible neonatal and early childhood hepatitis B cases using specific ICD-9 diagnosis and CPT procedure codes and validated cases through medical record review. Using Health Plan Employer Data and Information Set (HEDIS) data, we calculated vaccination coverage for the first dose of hepatitis B vaccine at 3-month intervals from January 1999 to September 2000.
The eligible populations in the "before," "during" and "after" cohorts were 29,347, 7791 and 29,215 infants, respectively. Of 41 possible hepatitis B cases identified in the 3 cohorts, we confirmed 1 case in the after cohort with medical record review. Despite receiving the first dose of hepatitis B vaccine and hepatitis B immunoglobulin within 12-24 hours of birth, the infant was diagnosed with laboratory-confirmed chronic hepatitis B at age of 9 months. An analysis of HEDIS data showed that vaccination coverage for the first dose of hepatitis B vaccine was 98% (January to March 1999) and 96% (April to June 1999) for the "before" cohort and 66% for the "during" cohort. For the "after" cohort the coverage was 72% (October to December 1999), 83% (January to March 2000), 91% (April to June 2000) and 95% (July to September 2000).
This study did not identify any perinatal hepatitis B transmission among health plan enrollees associated with the 1999 recommendation. The recommendation did result in a delay of hepatitis B birth dose in the "during" cohort as intended for infants born to hepatitis B surface antigen negative mothers. Six months after the recommendation was rescinded there was still a delay in the timing of first dose of hepatitis B vaccine, but the timing had returned to the prerecommendation level after 9-12 months.
1999年7月至9月，由于担心接触含硫柳汞疫苗会产生毒性，美国儿科学会和美国公共卫生服务局临时建议，对于母亲乙肝表面抗原阴性的婴儿，将首剂乙肝疫苗的接种时间推迟至2至6个月龄。我们的目标是确定该建议是否影响了多州管理式医疗人群中的围产期乙肝感染率；描述新生儿和儿童期乙肝感染病例，并评估该建议可能发挥的作用；以及根据美国儿童免疫规划评估生命最初2年疫苗接种的及时性。
我们确定了3组婴儿队列，分别在建议期之前（1998年7月至1999年6月）、期间（1999年7月至1999年9月）和之后（1999年10月至2000年9月）出生。我们使用自动化理赔数据，通过特定的ICD - 9诊断和CPT程序编码来识别可能的新生儿和儿童期乙肝病例，并通过病历审查来验证病例。利用健康计划雇主数据和信息集（HEDIS）数据，我们计算了1999年1月至2000年9月期间每隔3个月首剂乙肝疫苗的接种覆盖率。
“之前”“期间”和“之后”队列中的符合条件人群分别为29347名、7791名和29215名婴儿。在这3个队列中确定的41例可能的乙肝病例中，经病历审查，我们在“之后”队列中确认了1例。尽管该婴儿在出生后12至24小时内接种了首剂乙肝疫苗和乙肝免疫球蛋白，但在9个月龄时被诊断为实验室确诊的慢性乙肝。对HEDIS数据的分析显示，“之前”队列中首剂乙肝疫苗的接种覆盖率在1999年1月至3月为98%，1999年4月至6月为96%，“期间”队列为66%。“之后”队列的覆盖率在1999年10月至12月为72%，2000年1月至3月为83%，2000年4月至6月为91%，2000年7月至9月为95%。
本研究未发现与1999年建议相关的健康计划参保者中有任何围产期乙肝传播情况。该建议确实如预期那样导致了“期间”队列中母亲乙肝表面抗原阴性的婴儿乙肝首剂接种延迟。建议撤销6个月后，首剂乙肝疫苗接种时间仍有延迟，但9至12个月后接种时间已恢复到建议前水平。
