Title : Focus on vaccine safety: the clinical relevance to keep focusing on the close monitoring and safety surveillance of Covid-19 available and forthcoming vaccines. Can all the available and future safety clinical data be conveyed in one global safety database
Abstract:
History teaches us all about the course of past pandemics and the importance of the use of effective and safe vaccines to contribute to prevent diffuse bacterial and viral infections. But vaccines have also generated ethical controversies over the years. It is important to learn from the past and to make sure the efficacy and the safety of the available and future vaccines is continuously and carefully monitored.
There is an urgent need today to merge all serious and non-serious adverse events post COVID-19 vaccine administrations generated on a national and continental level, in order to globally assess the safety profile of these vaccines, so they can be conveyed in one only global clinical safety database. This harmonized and coordinated effort would allow generating a global clinical safety report to be continuously assessed and monitored by an independent global panel of safety experts across the world. The approach is of highest clinical relevance to figure out any potential safety signal emerging from all adverse events around the world post COVID-19 vaccinations. The approach would allow to eventually recalibrating, if deemed necessary, the clinical positioning and the labelling of the approved vaccines, which are currently utilized for preventing COVID-19 infection.
This abstract aims to generate awareness on this topic and to invite all involved regulatory authorities to collate all the adverse events arisen from every single country and to promptly disclose in one global report the available information related to the serious and non-serious side effects occurred post-COVID-19 vaccinations. This is of clinically high relevance, particularly to the whole world community. It is extremely important to carefully evaluate and not to downplay any emerging safety signal from the real world data, even if this was assessed as ‘minimal’.
Due to the accelerated timing to develop and to produce the approved COVID-19 vaccines by several regulatory agencies, also by considering the limited information from the available clinical studies at the time of their approval, i.e. because of the studies sample size; the limited number of patients/subgroups; the study durations, the absence at that time of the latest variants of the virus etc. based on prediction of more vaccines to become available, the clinical relevance to urgently identify vaccine-specific subgroups of people at higher risk to develop specific side effects, especially those most serious ones, all this is of high clinical importance. The approach could help to better understand the use of the existing vaccines and the most eligible populations needed to be vaccinated and to complete the full course of each vaccination. This is also relevant in light of future vaccination recalls and a full global vaccination campaign necessary to tackle the ongoing pandemic’.
