# Adverse Effects Following Covishield and Covaxin Vaccination in Pregnant and Non-pregnant Women: A Comparative Study From Ranchi, Jharkhand

## TL;DR

This study compares the adverse effects of Covishield and Covaxin vaccines in pregnant and non-pregnant women in India, finding similar safety profiles with Covaxin showing more side effects.

## Contribution

The study provides safety data on Covishield and Covaxin in pregnant women from a specific Indian population.

## Key findings

- Covaxin had a higher AEFI rate (41%) compared to Covishield (24%).
- Adverse effects like fever and local pain were similar in pregnant and non-pregnant women.
- No significant adverse maternal or fetal outcomes were linked to vaccination.

## Abstract

Background

Although COVID-19 vaccination in pregnancy has been approved by health authorities worldwide, data on adverse effects and safety profiles in pregnant women remain limited, particularly from diverse populations. Hence, this study aimed to compare the adverse effects following COVID-19 vaccination (Covishield and Covaxin) in pregnant and non-pregnant women in a tertiary care hospital in eastern India.

Methodology

This prospective, observational study was conducted at Rajendra Institute of Medical Sciences, Ranchi. Women aged 18-45 years receiving their first dose of COVID-19 vaccination were included and categorized into the following four groups: pregnant women receiving Covishield (Group A, n = 300), pregnant women receiving Covaxin (Group B, n = 357), non-pregnant women receiving Covishield (Group C, n = 446), and non-pregnant women receiving Covaxin (Group D, n = 100). Participants were followed up within 24 hours, at 7-14 days, after one month, and at delivery (for pregnant women). Adverse events following immunization (AEFIs) were recorded and analyzed using SPSS version 24.0 (IBM Corp., Armonk, NY, USA).

Results

Vaccine acceptance was 54.6% among pregnant women and 45.39% among non-pregnant women. The overall AEFI incidence rate was 41% for Covaxin and 24% for Covishield recipients (p < 0.001). Presence of allergy (adjusted odds ratio (AOR) = 1.950, 95% confidence interval (CI) = 1.379-2.757, p < 0.001) and vaccine type (AOR = 1.808, 95% CI = 1.408-2.322, p < 0.001) were significantly associated with AEFIs. Common adverse effects within 24 hours included fever, local pain at the injection site, and body aches, with similar profiles between pregnant and non-pregnant women. No significant adverse maternal or fetal outcomes were attributed to vaccination.

Conclusions

Both Covishield and Covaxin demonstrated acceptable safety profiles in pregnant and non-pregnant women, though Covaxin showed a higher AEFI rate. The types and frequencies of adverse effects were comparable between pregnant and non-pregnant women, suggesting that COVID-19 vaccination can be safely administered during pregnancy.