Safety of COVID-19 Vaccines Among Pregnant Women in India: A Systematic Review and Meta-Analysis.

Abstract

Coronavirus disease 2019 (COVID-19) documented an estimated decrease in life expectancy of 1.6 years globally. Pregnant women exhibited higher infection rates and experienced prolonged illness durations, often exceeding four months. COVID-19 was also related to adverse maternal morbidity and near-miss incidents. In India, although there are studies on the effectiveness of COVID-19 vaccines among the overall population, the effectiveness in preventing infections among pregnant women is not well documented. The present meta-analysis pooled the safety of the COVID-19 vaccine among pregnant women in India. The search was conducted among the major electronic databases: PubMed, Scopus, Web of Science, and Cochrane (date of search: November 30, 2024). Screening, risk of bias (ROB), and data extraction of the studies were undertaken by two independent reviewers, with adjudication of conflicts by a third reviewer. We described the pooled effectiveness of vaccination on adverse events following immunization (AEFI) and fetomaternal outcomes using RStudio (Posit Software, Boston, MA). The I² statistic assessed the heterogeneity among studies. We conducted a Grading of Recommendations Assessment, Development, and Evaluation (GRADE) assessment to ascertain the certainty of the results. Database search yielded 215 unique articles. We included nine eligible studies for the analysis, including 5,630 pregnant women. Covishield and Covaxin were the vaccines taken by them. The pooled odds ratio (OR) for preterm labor in mothers with COVID-19 vaccination was 0.62 (95% confidence interval (CI): 0.49-0.79), with low certainty. The OR for low birth weight was 0.88 (95% CI: 0.06-13.71). AEFI rates were similar between the vaccinated pregnant and non-pregnant women (OR: 0.88, 95% CI: 0.00-268.11). No studies on efficacy and effectiveness could be found. Our pooled analysis concluded that COVID-19 vaccination among pregnant women in India is not associated with the increased risk of AEFIs or maternal or fetal outcomes.