Pfizer BioNTech COVID-19 Vaccine Safety Subcommittee Meeting.
On January 19th 2021, the GACVS COVID-19 Vaccine Safety Subcommittee met online to review the available information and data on reported deaths in frail and elderly individuals who had received the Pfizer BioNTech COVID-19 mRNA vaccine BNT162b2. Experts invited by the European Medicines Agency (EMA) and the Uppsala Monitoring Center (UMC) provided an overview of the deaths reported in Europe and in the WHO global database following vaccination with BNT162b2. The analyses carried out revealed no unexpected increase in deaths in frail and elderly individuals.
The Global Advisory Committee on Vaccine Safety (GACVS), established in 1999 by the World Health Organization, provides a global, efficient, and scientifically exhaustive response to issues related to vaccination safety. GACVS assesses the standards of credibility, content, accessibility and planning that Vaccine Health Communication, i.e., the information resources offered by modern digital technologies on the subject of vaccine communication, should adhere to. Based on these criteria, WHO endorses scientifically based websites and adds them to the Vaccine Safety Net network (VSN) (Vaccine Safety Net) a global network of websites deemed by WHO to be reliable sources of information on vaccinations. Launched in 2003 by WHO, the Vaccine Safety Net Project, therefore, was created to spread correct, plausible and proven medical-scientific information on the web regarding the usefulness and safety of vaccines. It currently includes 53 certified web portals worldwide, including Italian sites such as the EpiCentro site and the IoVaccino site as well as the nationwide VaccinarSì Network.
Vaccinarsinsardegna.org has been proudly recognised as a certified means of vaccination communication within the worldwide VSN network together with the other websites of the VaccinarSì network, as reported in a GACVS statement in relation to recent deaths following administration of the Pfizer vaccine, shared by VSN with network members. The GACVS subcommittee met digitally on January 19th to review the available information and data on reported deaths in frail and elderly individuals who had received Pfizer BioNTech COVID-19 mRNA vaccine and to evaluate its safety. Experts invited by the European Medicines Agency (EMA) the Uppsala Monitoring Center (UMC) provided an overview of reported deaths in Europe and in the WHO global database following vaccination with BNT162b2.
Based on a careful scientific review of the information made available, the subcommittee concluded that the current reports do not suggest any unexpected or untoward increase in deaths in frail and elderly individuals and do not identify any unusual manifestations of adverse events following administration of the vaccine BNT162b2. Reports are in line with mortality rates and the available information regarding causes of death in the cohorts of frail and/or elderly individuals does not confirm a contributing role of the vaccine in reported fatalities. In light of this, the Committee considers that the benefit-risk balance of BNT162b2 remains favourable in the elderly and does not currently suggest any revision of the safety recommendations for this vaccine.
Countries should continue to monitor the safety of this vaccine and those pending approval, in order to promote after-care in line with good surveillance practices applied to all vaccines and/or drugs. The committee recommends that data on suspected adverse events be collected and reviewed on a timely and ongoing basis at the global, national, regional and local levels.
Attached is the WHO COVID-19 vaccine safety surveillance manual which provides countries with information on monitoring safety and sharing data on adverse events for the new COVID-19 vaccines.
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