How safe is COVID-19 vaccination among pregnant women and its outcome -A hospital-based retrospective study in Indian population

Background: Although susceptibility to COVID-19 infection exists for all, pregnancy is associated with relative immunological changes increasing vulnerability. Vaccination is a key preventive tool. Covishield and Covaxin were introduced in India, including for pregnant women, but safety was a concern, particularly for the newer vaccine platform. Objectives: To assess the safety of COVID-19 vaccination in pregnancy by evaluating pregnancy outcomes and adverse events following immunization (AEFI). Materials and Methods: Hospital-based retrospective cohort of all women delivering at a tertiary care hospital in Vadodara from July 2021 to April 2022. Vaccination status and antenatal details were extracted from institutional records. Results: Among 1974 pregnant women, 531 (27%) received COVID-19 vaccine (Covishield 96%, Covaxin 4%) and 1443 (73%) were unvaccinated. AEFI occurred in 46% of vaccinated women, most commonly fever (28%) and injection site pain (11%); no serious AEFI were reported. Low birth weight (LBW) was 40% in vaccinated vs 39% in unvaccinated; congenital malformation 0.6% vs 1% respectively. Preterm birth was lower in vaccinated (8%) vs unvaccinated (13%) and NICU admission was 8% vs 12% respectively. Conclusion: AEFI among pregnant women were fewer compared to reports from the general population. Both Covishield and Covaxin appeared safe regarding pregnancy outcomes and can be administered in any trimester; findings support reassurance by family physicians.