Angela Calugar1, Vitali Pool
2, Susan Reef
3, Weigong Zhou
4, and Robert Chen
2. (1) Immunization Safety Branch at the National Immunization program, CDC, NIP/ESD/ISB, E-61Centers For Disease Control and Prevention, 1600 Clifton Rd, NE, Atlanta, GA, USA, (2) National Immunization Program, Centers for Disease Control and Prevention, 1600 Clifton Road, MS-E61, Atlanta, GA, USA, (3) Centers for Disease Control and Prevention, National Immunization Program, Rubella/Mumps Activity Chief, 1600 Clifton Road, NE, MS E-61, Atlanta, Georgia, USA, (4) NCID, CDC, Mailstop A32, CDC, 1600 Clifton Rd, NE, atlanta, GA, USA
BACKGROUND:
Rubella infection during early pregnancy can result in congenital rubella syndrome (CRS). When rubella vaccines (RV) were introduced in 1969, pregnancy registries were established to monitor the safety of RV. No cases of CRS were found. Nevertheless because of the theoretical risk, RV is recommended for non-pregnant susceptible women of childbearing age. The US RV pregnancy registry was closed in 1989, however the US Vaccine Adverse Events Reporting System (VAERS) continues to receive spontaneous reports of RV use in pregnancy.
OBJECTIVE:
To review VAERS reports associated with inadvertent use of RV during pregnancy for cases consistent with CRS and for pregnancy outcomes.
METHOD:
Case-series study of RV records in pregnancy reported to VAERS from January 1, 1991 through December 31, 2003. The primary outcome of interest was CRS; secondary outcomes included congenital anomalies and pregnancy outcomes (live births, miscarriages, elective abortions, and fetal deaths).
RESULT:
Of 154 reported cases of administration of RV during pregnancy, 41 (27%) were live births, 27(18%) miscarriages, 24 (16%) elective abortions, and 3(2%) fetal deaths. Local and systemic reactions and lack of response to RV accounted for 30 cases; 29 (19%) reports had insufficient information for evaluation. Among live births, 16 reported congenital anomalies including three cases describing pulmonary atresia, microcephaly and bilateral sensory neural deafness (from Denmark, U.S, and U.K, respectively). Reviewed cases were lacking information for causality assessment. We observed no clustering by type of outcomes.
CONCLUSION:
No cases consistent with probable CRS were identified. This corroborates the earlier negative findings for RV associated CRS from the registries. No conclusion regarding etiology of reviewed cases could be made because of the limitation of passive surveillance data. A detailed clinical evaluation, virological testing, and follow up on any suspected infant congenital anomaly should be considered to rule out the vaccine etiology.
LEARNING OBJECTIVES:
Describe methods used for safety monitoring following inadvertent administration of RV.
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