Follow-up Study of Unknowingly Pregnant Women Vaccinated Against Rubella in Brazil, 2001–2002

Abstract

As rubella elimination goals are adopted worldwide, evidence of rubella vaccine safety aids in planning and implementation of mass adult immunization.

Congenital anomalies: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

“…The incidence of congenital rubella syndrome (CRS) following inadvertent rubella vaccination of pregnant women has been evaluated in several countries in Europe, the United States, Canada, Iran and Latin America. Among more than 3500 susceptible women inadvertently vaccinated against rubella shortly before or in the first trimester of pregnancy, no cases of CRS were reported [38], [39], [40], [41], [42], [43], [44], [45].…”

Adverse event following immunization surveillance systems for pregnant women and their infants: a systematic review

“…As evidence mounts on the importance of immunization during pregnancy, the value of surveillance for adverse events becomes increasingly clear. Studies of women inadvertently immunized with rubella vaccine during, or shortly before pregnancy as part of mass vaccination campaigns in Central and South America in 2001 to 2008 have provided evidence of the safety of this live attenuated vaccine during pregnancy . Careful assessment and follow‐up of thousands of such women failed to identify any cases of congenital rubella syndrome among their infants, suggesting that the risk, if any, is very low .…”

Vaccines and immunoglobulins

“…In a number of studies, data were analyzed covering more than 4,000 women who had been vaccinated from 3 months prior to conception and up to pregnancy. Data were collected from women in Germany, Sweden, England, Latin America, Iran and North America, some of them were already seropositive (Soares 2011, Nasiri 2009, Namaei 2008, Badilla 2007, Hamkar 2006, Enders 2005, Bar-Oz 2004. There were no cases of CRS after inadvertent exposure to rubella vaccine shortly before or during pregnancy, nor was there an association with other adverse effects.…”

“…During a mass vaccination campaign in Brazil, 2,332 susceptible women were vaccinated shortly before or during pregnancy. No children were born with CRS (Soares 2011).…”

“…Rubella-specific IgM antibodies can be documented in the cord blood of offspring of about 0-6% of women who had received the rubella vaccination during early pregnancy (Soares 2011, Hamkar 2006, Enders 2005, CDC 1989. A persistent subclinical infection was diagnosed in one case (Hofmann 2000).…”