The COVID-19 pandemic posed a significant threat, particularly to pregnant women with their compromised immunity. India approved Covishield and Covaxin in 2021, raising concerns about their safety in pregnancy due to their novel nature. This study aimed to evaluate the safety of COVID-19 vaccination on pregnancy outcomes and the incidence of AEFI among pregnant women in India. The second wave of the pandemic saw a surge in COVID-19 cases and deaths among pregnant women, prompting the National Technical Advisory Group on Immunization (NTAGI) to recommend vaccination for this population in July 2021. While the majority of infected pregnant women recovered without hospitalization, some experienced rapid deterioration, highlighting the need for vaccination. Although the Ministry of Health and Family Welfare approved the vaccination of pregnant women, acknowledging the need to balance risks and benefits, low vaccination coverage was expected initially due to limited safety data. This retrospective study, therefore, sought to address this gap in knowledge and provide crucial safety information to guide healthcare professionals counseling pregnant women about COVID-19 vaccination.

Existing literature on COVID-19 vaccine safety in pregnancy was largely from developed countries, with limited data from India. Studies from Chicago, Taiwan, and London using mRNA vaccines showed no increased risk of congenital anomalies with vaccination. Systematic reviews also showed no increased risk of stillbirth, miscarriage, premature delivery, or postpartum complications. However, there was a lack of research specifically on the Indian context and the use of Covishield and Covaxin during pregnancy. This absence of data presented a challenge for clinicians advising pregnant women in India regarding vaccination choices and potential risks.

This hospital-based retrospective cohort study analyzed data from the Healthy Mother Healthy Child (HMHC) project at Dhiraj Hospital in Vadodara, India, between July 2021 and April 2022. The study population comprised 1974 pregnant women who delivered at the hospital during this period. Exclusion criteria included incomplete ANC care, delivery outside Dhiraj Hospital, loss to follow-up, or lack of consent. Data on socio-demographics, vaccination status (Covishield or Covaxin), pregnancy outcomes (preterm birth, low birth weight, congenital malformations, NICU admission), and AEFI were collected from the HMHC software. Statistical analysis using Epi Info and Microsoft Excel included incidence rate, relative risk, and p-value calculations to assess the association between vaccination and pregnancy outcomes. The study was approved by the institutional ethics committee, and informed consent was obtained from all participants.

Of the 1974 women, 531 (27%) received at least one dose of a COVID-19 vaccine (511 Covishield, 20 Covaxin). AEFI were reported by 46% of vaccinated women, most commonly fever (28%) and injection site pain (11%). No serious AEFI (hospitalization or death) were reported. The incidence of low birth weight (LBW) was 40% among vaccinated mothers versus 39% in unvaccinated mothers (not statistically significant). The incidence of congenital malformations was 0.6% in the vaccinated group versus 1% in the unvaccinated group (not statistically significant). However, vaccination was associated with a significantly lower risk of preterm birth (RR = 0.624, p = 0.0039) and NICU admission (RR = 0.699, p = 0.028).

This study provides valuable data on the safety of Covishield and Covaxin in pregnant women in India. The relatively low AEFI rate compared to the general population suggests that these vaccines are well-tolerated in this group. The lack of increased risk for LBW or congenital anomalies is reassuring. The finding of a protective effect against preterm birth and NICU admission is particularly important. These findings align with similar studies conducted elsewhere using mRNA vaccines. The study highlights the importance of vaccination in protecting pregnant women and their babies, while addressing safety concerns that might hinder uptake. While this study adds to the existing body of evidence, more research may be needed to explore the reasons for the protective effect of vaccination observed against preterm birth and NICU admission.

This study is the first of its kind in India to assess the safety and pregnancy outcomes associated with Covishield and Covaxin vaccines. Both vaccines were found to be safe for pregnant women and their babies, with a potential protective effect against preterm birth and NICU admission. This information is crucial for healthcare professionals counseling pregnant women about COVID-19 vaccination. Future research could involve larger, multicenter studies to strengthen the generalizability of findings and further investigate the observed protective effects.

The study’s limitations include its retrospective design and single-center setting, which may limit the generalizability of the findings to other populations. The reliance on self-reported AEFI might lead to underreporting. Further, the limited number of women who received Covaxin might have affected the precision of the analysis related to that specific vaccine.