ACTIVE SURVEILLANCE OF THE SPUTNIK V VACCINE IN HEALTH WORKERS release_brjischurzh5xju4zrdhxw2cfe

by Vanina Pagotto, Analia Ferloni, Maria Mercedes Soriano, Morena Diaz, Nahuel Braguinsky, Valeria Asprea, Maria Ines staneloni, Gustavo Gabriel Vidal, Martin Guido Silveira, Paula Zingoni, Valeria Aliperti, Hernan Michelangelo (+1 others)

Released as a post by Cold Spring Harbor Laboratory.

2021  

Abstract

Introduction The World Health Organization (WHO) recommends vaccination against Sars Cov-2 coronavirus to mitigate COVID-19 pandemic. On December 29th, the Argentine Ministry of Health started a vaccination plan with the Sputnik V vaccine emphasizing the registration of the Events Supposedly Attributed to Vaccines and Immunizations (ESAVI) in the National Surveillance System. The aim of this study is to determine the safety of this vaccine. Methods In an ongoing cohort study, health professionals from Hospital Italiano de Buenos Aires vaccinated with the first component of the Sputnik V vaccine (a rAd26 vector-based) were followed up. Safety at 72 hs was analysed from a self-report form. Local and systemic reactions were characterized as mild, moderate and severe. Incident rates were calculated per 1000 person-hours by age groups and gender. Adjusted hazard ratio and 95% Confidence Interval (HR; 95%CI) is obtained by Cox Regression Model. Results 707 health professionals (mean age 35, 67% female) were vaccinated, response rate was 96,6% and 71,3% reported at least one ESAVI. Rate was 6.3 per 1.000 person-hours. Among local reactions, 54% reported pain at the injection site, 11% redness and swelling. Among systemic reactions 40% reported fever, 5% diarrhea and 68% new or worsened muscle pain. Five percent had serious adverse events that required medical evaluation and one inpatient. ESAVI rate was higher among females (65.4% vs 50%; HR 1.38, 95%CI 1.13-5.38) and in younger than 55 years-old (72.8% vs 32%; HR 2.66, 95%CI 1.32-1.68). Conclusion Active surveillance on safety for vaccines with emergency approval is mandatory. This study shows high rates of local and systemic reactions however early serious events were rare. Short term safety is supported by these preliminary findings. Studies on long term safety and efficacy, accoding sex and age, are needed.
In application/xml+jats format

Archived Files and Locations

application/pdf  486.9 kB
file_6s6cu5ckinc3lb3gyrshjpgnpe
web.archive.org (webarchive)
www.medrxiv.org (repository)
Read Archived PDF
Archived
Type  post
Stage   unknown
Date   2021-02-05
Work Entity
access all versions, variants, and formats of this works (eg, pre-prints)
Catalog Record
Revision: c7f69b76-89c2-461f-8ab2-83877bb2c6f5
API URL: JSON