Adverse events reported from the COVID-19 vaccines: a descriptive study based on the WHO database (VigiBaseR)

The emergency approval of a few COVID-19 vaccines provided a ray of hope to fight the deadly pandemic. However, their approval was solely based on limited data from the clinical trials in a short period, thereby imposing a demand for post-marketing surveillance studies to monitor beneficial and adverse events (AEs). This study focuses on observing the serious adverse events (SAEs) data reported in the World Health Organization database. The data from VigiBaseR was analyzed. The duplicates in the data were removed and analyzed based on age, gender, and SAEs at the system organ classification level and the individual preferred term level. A total of 103,954 AEs were reported. The majority of them were seen as females (80%), from Europe (83%), and were between 18 and 64 years (80.74%) of age. The most-reported AEs were of the nervous system (19.1%), musculoskeletal (11.2%), and elderly (>65 years) people. The reported SAEs from the COVID-19 vaccines were in line with the data published in the clinical trial reports. These SAEs to vaccines will need causality analysis and review of individual reports.

Efficacy and Safety of Ayurveda Intervention AYUSH 64 as add-on therapy for patients with COVID 19 infections: An open labelled, Parallel Group, Randomized controlled clinical trial (preprint)

The authors have withdrawn this manuscript because they found a serious issue in data-analysis which leads to wrong interpretation of the results. Therefore, the authors do not wish this work to be cited as reference for the project. If you have any questions, please contact the corresponding author.

Longitudinal protection following natural SARS-CoV-2 infection and early vaccine responses: insights from a cohort of community based dental health care professionals (preprint)

Abstract Background The threshold of protection for anti-SARS-CoV-2 spike glycoprotein antibodies and their longevity are not known. Interpretation of serological results in with respect to international reference material can inform this essential question. Methods 1,507 West Midlands dental care professionals were recruited into this study in June 2020. Baseline seroprevalence of antibodies directed against the SARS-CoV-2 spike glycoprotein was determined and the cohort was followed longitudinally for 6 months until January/February 2021 through the second wave of the COVID-19 pandemic in the United Kingdom, and commencement of vaccination. Results Baseline seroprevalence was 16.3% in this cohort, compared to estimates in the general population of between 6-7%. Seropositivity was retained in over 70% of participants at 3 and 6-month follow up and conferred a 74% reduced risk of infection. During follow-up, no PCR-proven infections occurred in individuals with a baseline anti-SARS-CoV-2 IgG level greater than 147.6 IU/ml with respect to the World Health Organization international standard 20-136. Post-vaccination, antibody responses were more rapid and of higher magnitude in individuals with who were seropositive at baseline. Conclusion Natural infection leads to a serological response that remains detectable in over 70% of individuals 6 months after initial sampling and 9 months from the peak of the first wave of the pandemic. This response is associated with protection from future infection. Even if serological responses wane, a single dose of the Pfizer-BioNTech vaccine is associated with an antibody response indicative of immunological memory. Funding The Association of Clinical Biochemistry and Laboratory Medicine and The Institute for Global Innovation (IGI) of the University of Birmingham.