Milan, May 24 (beraking latest news Salute) – An App will monitor the safety of anti-Covid vaccines in pregnant women, children and adolescents, and in immunocompromised patients, with a history of allergies or already affected by the Sars-CoV-2 virus in 11 European countries . It is the ‘Covid-Vaccine-Monitor’ project funded by the European drug agency Ema, which is headed by the Dutch Utrecht University Medical Center and provides for our country “a leading role”, according to the Company. Italian Pharmacology (Sif). “In fact, a special” tricolor “network was set up coordinated by the University of Verona, with the involvement of various vaccination, academic and regional pharmacovigilance centers, together with Sif, the Italian Society of General Medicine (Simg) and the Association national rheumatic patients (Anmar) “.
The details of the initiative, which will last 2 years, will be illustrated on Friday 28 May during the webinar ‘Post-marketing surveillance of vaccines against Covid-19: where do we stand?’, Promoted by Sif with the support of the International Society of Pharmacovigilance (Isop) and the Italian drug agency Aifa. The web App will allow you to check short and long-term adverse reactions, as well as the effectiveness of anti-Covid vaccines in categories that have been excluded from most of the pre-marketing studies conducted on shield products. Hence the importance of the so-called ‘phase 4’ following marketing, “the pharmacovigilance phase – recalls Sif – during which the product, already in use, is kept under control to detect any side effects that may have escaped the preclinical and clinical tests previous “.
“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 – says Sif president Giorgio Racagni – It is understandable why the data from Real World Evidence (Rwe), 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’s studies can give results in the short term and with limited costs “.
“The serious pandemic situation due to the impact of Covid-19 – the expert also highlights – underlines the need to generate scientific evidence that supports the decisions of the regulatory agencies, appointed to grant authorizations for trials and the possible marketing of drugs and vaccines, supplementing the precious data already collected through the spontaneous reporting system of adverse reactions of individual countries “.
Coordinating the network of Italian partners participating in the project is the University of Verona with Sif member Gianluca Trifirò, full professor of Pharmacology and scientific director 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 pre-marketing studies on Covid vaccines, is strategic – confirms the expert – because it will enrich us with information that it was not possible to acquire at the start, and in this context, the data from Real World Evidence are absolutely fundamental “.
“The web App was developed by Dutch colleagues and then adapted to the Italian context – specifies Trifirò – In particular, vaccinated people who join the study will have to register on the App within 48 hours of the vaccine and fill in a basic electronic questionnaire, followed by the timed sending of questionnaires by 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 check the long-term effects and the possible appearance of Sars-CoV-2 infection “.