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.
The number of overdose deaths are on the rise all over the world. An estimate of 93,000 drug overdose deaths have been estimated in the United States in 2020. COVID-19 pandemic has exacerbated the drug crisis. Factors, such as existing health disparities among underserved communities, lack of resources for people of color, lack of belief in available resources, social isolation and economic burden, limited access to treatment, regulatory barriers in telehealth, and stress from the on-going COVID-19 pandemic have been identified as some of the key factors behind the acute health effects of people with substance use disorder. These interrelated factors exacerbate the impact of already existing disparities in the underserved communities. Policy and regulatory changes around telehealth and access of treatment for substance use disorder are warranted. Evidence-based strategies and other safer drug practices should be implemented to mitigate the impact on human health. Investment in programs that increase access to treatment, will be useful for potential future pandemics, where increasing mental health services and overall access to healthcare in disadvantaged communities would lessen the disparities in physical and mental ailments. In this review, we are evaluating and summarizing the acute health effects of the ongoing COVID-19 pandemic on individuals with substance use disorder.
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