Evaluation of safety concerns for COVID-19 immunization of pregnant women: A systematic review of emerging evidence (preprint)

Background: There is an urgent need to review the status of COVID-19 vaccine immunization in pregnant women globally so that the adverse outcomes may be prevented. Objective: To evaluate the probable outcome of COVID-19 vaccination in pregnant women. Search strategy: An electronic search was conducted over the period of 3 months (June 15-August 15, 2021). Selection criteria: The original studies evaluating safety concerns in pregnant women for COVID-19 vaccination were included. Data collection and analysis: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2009 guidelines were used for the collection of the data and reporting of the findings. The inclusion and exclusion criteria for the studies were determined based on ‘PICO principle’ (Population, Intervention, Comparator, and Outcome, Study design. Risk of bias assessment was done using National Institute of Health (NIH) tool for systematic reviews. Main results: COVID-19 vaccination in pregnant women was not associated with increased adverse effects or complications to the mother as well as developing fetus or newborn compared to non-vaccinated pregnant women. Vaccinated pregnant women showed a robust immune response against COVID-19 infection. Conclusions: COVID-19 vaccination during pregnancy causes no significant health risks for the mother or developing fetus or newborn.

Evaluation of safety concerns for COVID-19 immunization of pregnant women: A systematic review of emerging evidence (preprint)

Objectives There is an urgent need to review the status of COVID-19 vaccine immunization in pregnant women globally so that the adverse outcomes may be prevented. In this study we performed a systematic review of the available literature to evaluate the probable outcomes of COVID-19 vaccination in pregnant women.Methods An electronic search was conducted over the period of 3 months (June 15-August 15, 2021). The original studies evaluating safety concerns in pregnant women for COVID-19 vaccination were included. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2009 guidelines were used for the collection of the data and reporting of the findings. The inclusion and exclusion criteria for the studies were determined based on ‘PICO principle’ (Population, Intervention, Comparator, and Outcome, Study design. Risk of bias assessment was done using National Institute of Health (NIH) tool for systematic reviews.Results COVID-19 vaccination in pregnant women was not associated with increased adverse effects or complications to the mother as well as developing fetus or newborn compared to non-vaccinated pregnant women. Vaccinated pregnant women showed a robust immune response against COVID-19 infection.Conclusions COVID-19 vaccination during pregnancy causes no significant health risks for the mother or developing fetus or newborn.

Demographic characteristics of SARS-CoV-2 B.1.617.2 (Delta) variant infections in Indian population (preprint)

ImportanceHigher risks of contracting infection, developing severe illness and mortality are known facts in aged and male sex if exposed to the wild type SARS-CoV-2 strains (Wuhan and B.1 strains). Now, accumulating evidence suggests greater involvement of lower age and narrowing the age and sex based differences for the severity of symptoms in infections with emerging SARS-CoV-2 variants. Delta variant (B.1.617.2) is now a globally dominant SARS-CoV-2 strain, however, current evidence on demographic characteristics for this variant are limited. Recently, delta variant caused a devastating second wave of COVID-19 in India. We performed a demographic characterization of COVID-19 cases in Indian population diagnosed with SARS-CoV-2 genomic sequencing for delta variant. ObjectiveTo determine demographic characteristics of delta variant in terms of age and sex, severity of the illness and mortality rate, and post-vaccination infections. DesignA cross sectional study SettingDemographic characteristics, including vaccination status (for two complete doses) and severity of the illness and mortality rate, of COVID-19 cases caused by wild type strain (B.1) and delta variant (B.1.617.2) of SARS-CoV-2 in Indian population were studied. ParticipantsCOVID-19 cases for which SARS-CoV-2 genomic sequencing was performed and complete demographic details (age, sex, and location) were available, were included. ExposuresSARS-CoV-2 infection with Delta (B.1.617.2) variant and wild type (B.1) strain. Main Outcomes and MeasuresThe patient metadata containing details for demographic and vaccination status (two complete doses) of the COVID-19 patients with confirmed delta variant and WT (B.1) infections were analyzed [total number of cases (N) =9500, Ndelta=6238, NWT=3262]. Further, severity of the illness and mortality were assessed in subsets of patients. Final data were tabulated and statistically analyzed to determine age and sex based differences in chances of getting infection and the severity of illness, and post-vaccination infections were compared between wild type and delta variant strains. Graphs were plotted to visualize the trends. ResultsWith delta variant, in comparison to wild type (B.1) strain, higher proportion of lower age groups, particularly <20 year (0-9 year: 4.47% vs. 2.3%, 10-19 year: 9% vs. 7%) were affected. The proportion of women contracting infection were increased (41% vs. 36%). The higher proportion of total young (0-19 year, 10% vs. 4%) (p=.017) population and young (14% vs. 3%) as well as adult (20-59 year, 75% vs. 55%) women developed symptoms/hospitalized with delta variant in comparison to B.1 infection (p< .00001). The mean age of contracting infection [Delta, men=37.9 ({+/-}17.2) year, women=36.6 ({+/-}17.6) year; B.1, men=39.6 ({+/-}16.9) year and women= 40.1 ({+/-}17.4) year (p< .001)] as well as developing symptoms/hospitalization [Delta, men=39.6({+/-} 17.4) year, women=35.6 ({+/-}16.9) year; B.1, men=47({+/-}18) year and women= 49.5({+/-}20.9) year (p< .001)] was considerably lower. The total mortality was about 1.8 times higher (13% vs. 7%). Risk of death increased irrespective of the sex (Odds ratio: 3.034, 95% Confidence Interval: 1.7-5.2, p<0.001), however, increased proportion of women (32% vs. 25%) were died. Further, multiple incidences of delta infections were noted following complete vaccination. Conclusions and RelevanceThe increased involvement of young (0-19 year) and women, lower mean age for contracting infection and symptomatic illness/hospitalization, higher mortality, and frequent incidences of post-vaccination infections with delta variant compared to wild type strain raises significant epidemiological concerns. Key PointsO_ST_ABSQuestionC_ST_ABSDid SARS-CoV-2 B.1.617.2 (Delta) variant infections show varied demographic characteristics in comparison to wild type strains? FindingsIn this cross sectional study viral genomic sequences of 9500 COVID-19 patients were analyzed. As the key findings, increased involvement of young (0-19 year) and women, lower mean age for contracting infection and symptomatic illness/hospitalization, higher mortality, and frequent incidences of post-vaccination infections with delta variant in comparison to wild type (WT) strain (B.1) were observed. MeaningThe findings of this study suggest that delta variant has varied demographic characteristics reflecting increased involvement of the young and women, and increased lethality in comparison to wild type strains.