COVID-19 vaccination uptake and adverse events following COVID-19 immunization in pregnant women in Northern India: a prospective, comparative, cohort study

Abstract

Objectives:The most commonly used vaccine in India, Covishield, is a recombinant adenovirus vector vaccine for which safety data in pregnant women are not available. The present study was conducted to assess the uptake of COVID-19 vaccines and monitor adverse events following COVID-19 immunization among pregnant women in northern India. Patients and Methods: A prospective cohort study was conducted among pregnant women registered with the antenatal clinics in Chandigarh Union Territory (U.T.) in northern India. The study included 247 pregnant women and a comparative group of age-matched, non-pregnant women (247) who received the first dose of the COVID-19 vaccine and were followed up by telephone interviews for adverse events following immunization at three time points until 28 days after vaccination. Multivariate regression (logistic and linear) was used for the adjusted analysis, with adverse events following immunization and the duration of adverse events following immunization as the outcomes. Results:The COVID-19 vaccination uptake rate was 66.8% among the pregnant women. The 28-day incidence rate of adverse events following immunization among the pregnant women was 76.5%. The overall 28-day incidence of adverse events following immunization in pregnant women did not differ significantly from that of non-pregnant women (P=0.153). Conclusion:The Covishield vaccine is safe for pregnant women in India. Further follow-up of the cohort for feto-maternal outcomes needs to be conducted with an adequate sample size to confirm the overall safety profile of the vaccine.

Adverse events following COVID-19 vaccination among pregnant women attending primary health centers: An active-surveillance study

“…In our study, majority of the adverse events following COIVD-19 vaccination were reported within 1 day. Similar findings are also observed in the studies conducted by Goldshtein et al and Gandhi et al 8 , 25 It indicates that majority of the adverse events are either fever or injection site pain that are nearly similar with the routinely used pediatric or adult vaccines. The current study actively captured all events within 30 min after COVDI-19 vaccination among pregnant women, thereafter pregnant women passively report the adverse events experienced in the 30 days after vaccination.…”

“…Similar severe adverse events are also reported among 234 pregnant women vaccinated with Covaxin in Mumbai, India. 8 …”

“… 7 Considering the safety profile of the COVID-19 vaccine in pregnant women generated by other countries, India started vaccinating pregnant women based on emergency use license from the first week of July 2021. 8 …”

Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes: a systematic review and meta-analysis

“…We included 16 studies (425 867 women) reporting SARS-CoV-2 infection-related outcomes6 7 17 19 21 31 33 36 38–45 and 35 (1 362 172 women) reporting pregnancy-related maternal and offspring outcomes in the secondary analysis 17 18 21–24 29–34 36 38 39 41–60. Twenty-three studies reported reactogenicity outcomes (94 206 women) following vaccination 38 39 46 61–80…”

Uptake and impact of COVID-19 vaccination among HIV key populations: a cohort study from Tamil Nadu, India

“…Among the general population aged 45+ years in Tamil Nadu, a vaccination rate of 64% was reported between June–September 2021 19 ) . Among the general population in other parts of India, Arora et al and Dhumal et al reported that the uptake was 54.6% and 82.1%, respectively 20 , 21 ) , whereas Gandhi et al reported an uptake rate of 66.8% among pregnant women in Northern India 22 ) . However, the time interval between the present study and these studies was one year 19 , 20 , 21 ) .…”