Estimation of the adverse effects following immunization after SARS-CoV-2 Vaccine (Covishield and Covaxin) in lactating women: A single centre exploratory study from India

Abstract

ABSTRACT Context: The global COVID-19 pandemic has universally impacted individuals, with lactating women being uniquely susceptible to severe infection. Vaccination plays a critical role in building population immunity, mitigating severe illness and curtailing the health crisis. However, data on adverse effects and vaccine safety in lactating women remains scarce. Aims: To assess the prevalence and types of adverse effects post-COVID vaccination in lactating women. Methods: This study was conducted at a tertiary care hospital’s COVID-19 vaccination centre in North India, and followed a prospective observational design over a specific timeframe. A total of 200 lactating women were surveyed, with specific inclusion and exclusion criteria applied. Telephonic follow-up was conducted for one month after the first dose for 152 participants and after the second dose for 123 participants. Adverse effects following immunization (AEFIs) were recorded and analyzed. Results: Of the study cohort, 45 (29.60%) reported minor adverse effects following the first vaccine dose, with just four (3.25%) experiencing adverse effects after the second dose. Common AEFIs included fever (18.42%) and body aches (9.21%), along with headache, malaise, injection site pain and diffuse abdominal pain. Conclusions: This study provides valuable insights into the adverse effects of COVID-19 vaccines in lactating women, which can help primary physicians and policy maker to improve vaccination policies and guidelines. The study revealed that lactating mothers experienced only mild AEFIs, aligning with current literature. Further broader, multicentre research is needed to reinforce these findings and to assess the long-term safety and efficacy of COVID-19 vaccines in this population.