Safety and Efficacy of the Rubella Vaccine in the Immediate Postpartum Period: A Systematic Review of the Literature

Context: Immunization against rubella is recommended in the immediate postpartum period in order to prevent congenital rubella syndrome. To date, there is no systematic review of the studies examining the safety and efficacy of the vaccine.

Objective: To critically review literature addressing the safety and efficacy of rubella vaccines administered immediately postpartum.

Design: A systematic search of the MEDLINE, CINAHL, Psycinfo, and Cochrane Library databases was performed up to September 1999 to find all English-language, human, randomized controlled trials of interventions pertaining to rubella vaccination conducted within North America, Europe, Australia, or New Zealand.

Main Outcome Measures: Seroconversion rates and assessments of adverse side effects among the study participants.

Results: Two randomized controlled trials met the inclusion criteria. The first study examined the efficacy and adverse effects of two postpartum rubella vaccines (RA27/3 and Candehill). The results indicated a 97.6% seroconversion among women who received the RA27/3 vaccine compared with an 82.2% seroconversion rate in the Candehill group. Painful joints, soreness at the injection site and fever were reported by 24%, 11% and 11% of those in the RA/27/3 group compared with 12%, 0% and 16% of those who received Candehill. The second, study assessed only the adverse effects of RA27/3. There were no reports of fever or soreness at the injection site, and no significant difference in the occurrence of myalgias/paraesthesias between the intervention and placebo group. There was a significantly increased risk of arthralgia/arthritis in the RA27/3 group, both at 4 weeks and 12 months following vaccination (OR 1.73 (1.17-2.57) and 1.58 (1.01-2.45) respectively).

Conclusion: RA27/3 (currently used in North America) given in the immediate postpartum period appears to be effective with a small risk of arthralgia/arthritis at 12 months post vaccination. Larger, methodologically rigorous RCTs are needed to verify the efficacy and adverse effects in other populations.