Home » Covid, a new App will monitor the safety of vaccines

Covid, a new App will monitor the safety of vaccines

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MONITOR the safety of Covid-19 vaccines. This is the purpose of a project, funded by the European Medicines Agency (Ema), which will last two years and will allow, through an app used in 11 European countries, to track adverse reactions (therefore safety) in a short time. and long-term, as well as the effectiveness of coronavirus immunizations in special categories of patients such as pregnant women, children and adolescents, immunocompromised patients and people with a history of allergy or previous Covid infection.

These are in fact the categories of frail people which have been excluded from much of the preliminary studies of corornavirus vaccines. For this reason, monitoring in the current phase of successful marketing is absolutely essential. Once on the market, drugs and vaccines, in fact, pass to the so-called phase 4, the pharmacovigilance phase, during which the product, already in use, is kept under control to detect any side effects that may have escaped the previous preclinical and clinical tests.

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Pharmacovigilance

The pharmacovigilance phase is particularly valuable, because drugs and vaccines, once on the market, are taken by many millions of people, so many more than the tests of the traditional clinical phases (including those who are generally not enrolled in premarketing studies). giving us a snapshot of safety and effectiveness in the real world. It is no coincidence that these data are defined as Real World Evidence (RWE) data.

“In the current situation it is essential to rapidly establish the risk-benefit profiles of vaccines which represent the only effective weapon against the virus – explains the President of the Italian Society of Pharmacology. Giorgio Racagni -. It is understandable why Real World Evidence (RWE) data, that is, deriving from the phase immediately following commercialization, are precious, since the “real world” is made up of a sample of many millions of people. Furthermore, RWE studies can give results in the short term and with limited costs “.

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The network in Italy

The Dutch Utrecht University Medical Center will lead the project, with our country playing a leading role. In fact, an Italian network was set up coordinated by the University of Verona, with the involvement of various vaccination centers, academic centers and regional pharmacovigilance centers, together with the Italian Society of Pharmacology (SIF), the Italian Society of General Medicine (SIMG) and the National Association. of Rheumatic Patients (ANMAR).

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The Italian Society of Pharmacology has therefore set up a group of experts with the aim of examining the role of this data in health emergency situations just like the one we are going through, to compare the risk and benefit profiles of the various products approved in Europe: Pfizer -BionTech, Moderna, AstraZeneca and Johnson & Johnson. “The serious pandemic situation due to the impact of Covid – continues Racagni – underlines the need to generate scientific evidence that supports the decisions of the Regulatory Agencies, namely the European Medicines Agency and the Italian Medicines Agency, appointed to grant authorizations for trials and the possible marketing of drugs and vaccines, supplementing the valuable data already collected through the spontaneous reporting system for adverse reactions of individual countries “.

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Adverse reactions

Coordinating the network of Italian partners participating in the project is the University of Verona, with Gianluca Trifirò, SIF member, Full Professor of Pharmacology of the same university as well as scientific manager of the academic spin-off INSPIRE – Innovative Solutions For Medical Prediction And Big Data Integration In Real World Setting “The monitoring of the most fragile categories, which have not been included in most of the premarketing studies on Covid-19 vaccines, is strategic because it will enrich us with information that it was not possible to acquire at the start, and in this context the data of the Real World Evidence are absolutely essential. The app was developed by Dutch colleagues and then adapted to the Italian context. In particular, vaccinated people who join the study will have to register on the web app within 48 hours of the vaccine and fill in a basic electronic questionnaire, followed by the timed sending of questionnaires via e-mail at 1 and 3 weeks from the first. dose and from the second dose, and then at 3 and 6 months from the first dose, to control the long-term effects and the possible occurrence of Sars-COV-2 infection “.

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