Browsing by Author "Mahek Rai"

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RETRACTED ARTICLE: Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India (Drug Safety, (2024), 47, 12)
(Adis, 2024) Upinder Kaur; Aakanksha Jaiswal; Ayushi Jaiswal; Kunal Singh; Aditi Pandey; Mayank Chauhan; Mahek Rai; Sangeeta Kansal; Kishor Patwardhan; Vaibhav Jaisawal; Sankha Shubhra Chakrabarti
The Editor has retracted this article as he no longer has confidence in the conclusions as stated in the article. Post-publication review concluded that the reported adverse events of special interest (AESIs) were presented in a way that could lead to ambiguous or incorrect interpretations regarding the relationship with the BBV152 vaccine. Given these findings, the editor and the publisher have decided that this article should be removed on public health grounds. The authors disagree with this retraction. © The Author(s)
Risk factors of cardiovascular adverse events in ChAdOx1-nCoV-19-vaccinated priority groups in North India
(Elsevier B.V., 2025) Noti Taruni Srija Reddy; Mahek Rai; Sankha Shubhra Chakrabarti; Upinder Kaur
Rationale: Studies on determinants of cardiovascular adverse events (CVAEs) in ChAdOx1-nCoV-19 vaccine recipients are scarce. Methods: This is a subgroup analysis of our published one-year prospective study (February 2021 to April 2022) on the safety of the ChAdOx1-nCoV-19 vaccine. Healthcare workers and the elderly were the core study participants (priority vaccine recipients) who were followed up telephonically for one year after vaccination. Patterns of CVAEs and their risk factors were analyzed. Results: Out of 1650 enrolled participants, the data on CVAEs were available for 1525. Cardiac AEs and vascular AEs occurred in 1.4 % and 1.8 %, respectively. CVAEs were serious in 0.45 % of participants. Obese individuals had 3.8- and 2-times higher odds of cardiac and vascular AEs, respectively. Individuals aged 40 years and above had 3 times higher odds of vascular AEs. Cardiac AEs were significantly more common after the first dose of the vaccine. No association was seen between CVAEs and COVID-19 before or after vaccination. The rates of persistent CVAEs were 2.4–3.1 %, 1.1–1.3 %, and 0.5–0.9 % in the Vaccine After COVID (VAC) group, COVID After Vaccine (CAV) group, and Vaccine NO COVID (VNC) group, respectively. Conclusion: The occurrence of CVAEs might be governed by the number of vaccine doses, age, obesity, and timing of the vaccine with respect to natural SARS-CoV-2 infection. While no causality can be established between the observed events and vaccination, individuals receiving any dose of vaccine after recovery from COVID-19 need extended monitoring for CVAEs. Larger studies including unvaccinated individuals are required to understand the predictors of CVAEs for the individualization of future vaccination policies. © 2025 The Authors