Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Vaccine. 2010 Sep 14;28(40):6609-12. doi: 10.1016/j.vaccine.2010.07.039. Epub 2010 Jul 30.
Rotavirus vaccines are the only live vaccines recommended for infants in the US. Postmarketing reports have described severe gastroenteritis with vaccine viral shedding in infants who received rotavirus vaccine and were later diagnosed with SCID. The US Food and Drug Administration recently approved labeling changes for RotaTeq and Rotarix contraindicating administration to individuals with a history of SCID. We queried VAERS to characterize reports of SCID after rotavirus vaccination.
VAERS inclusion criteria included current US-licensed rotavirus vaccines, report dates from February 3, 2006 to January 15, 2010, and queries for the MedDRA preferred term "combined immunodeficiency" as well as any text containing the terms, "SCID" or "combined immunodeficiency."
We identified nine reports of SCID and rotavirus vaccination in infants between 3 and 9 months of age. All but one case presented with diarrhea among other symptoms. All infants were hospitalized and had workups leading to the SCID diagnosis. Stool rotavirus testing was positive in all cases and the virus was identified as the vaccine strain in six cases. Prolonged viral shedding was documented in five cases. No deaths were reported.
The aforementioned labeling changes were warranted given the risk posed by live rotavirus vaccine to individuals with SCID, as illustrated by these VAERS cases. Although congenital, SCID was not diagnosed in these infants until after rotavirus vaccination. Earlier identification of SCID (e.g., from expanded newborn screening or heightened clinical vigilance) could prevent inadvertent live rotavirus vaccine administration and also potentially result in earlier life-saving stem cell transplants.
轮状病毒疫苗是唯一被推荐给美国婴儿使用的活疫苗。上市后报告描述了在接种轮状病毒疫苗并随后被诊断为 SCID 的婴儿中出现严重的胃肠炎和疫苗病毒脱落。美国食品和药物管理局最近批准了 RotaTeq 和 Rotarix 的标签变更，禁止向有 SCID 病史的个体使用。我们查询了 VAERS 以描述轮状病毒疫苗接种后 SCID 的报告。
VAERS 的纳入标准包括目前在美国许可的轮状病毒疫苗、报告日期为 2006 年 2 月 3 日至 2010 年 1 月 15 日，以及 MedDRA 首选术语“联合免疫缺陷”的查询以及任何包含术语“SCID”或“联合免疫缺陷”的文本。
我们确定了 9 例 3 至 9 个月大婴儿的 SCID 和轮状病毒疫苗接种报告。除了一个病例外，所有病例均出现腹泻等其他症状。所有婴儿均住院治疗，并进行了导致 SCID 诊断的检查。所有病例的粪便轮状病毒检测均呈阳性，6 例病毒被鉴定为疫苗株。5 例病例记录了病毒的持续脱落。未报告死亡。
鉴于活轮状病毒疫苗对 SCID 个体构成的风险，上述标签变更得到了保证，这些 VAERS 病例说明了这一点。尽管是先天性的，但直到接种轮状病毒疫苗后，这些婴儿才被诊断出 SCID。更早地识别 SCID（例如，通过扩展的新生儿筛查或更高的临床警惕性）可以防止意外接种活轮状病毒疫苗，并且还可能导致更早的救命干细胞移植。
