GACVS COVID-19 Vaccine Safety subcommittee meeting to review reports of deaths of very frail elderly individuals vaccinated with Pfizer BioNTech COVID-19 vaccine

The GACVS COVID-19 Vaccine Safety subcommittee met virtually on Tuesday, 19 January 2021, to review available information and data on deaths reported in frail, elderly individuals who had received the Pfizer BioNTech COVID-19 mRNA vaccine, BNT162b2 (hereafter, BNT162b2). Experts invited from the European Medicines Agency (EMA) and the Uppsala Monitoring Center (UMC) provided an overview of deaths reported in Europe and in the WHO global database (VigiBase) following vaccination with BNT162b2.

Based on a careful scientific review of the information made available, the subcommittee came to the following conclusions:

The current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of BNT162b2. Reports are in line with the expected, all-cause mortality rates and causes of death in the sub-population of frail, elderly individuals, and the available information does not confirm a contributory role for the vaccine in the reported fatal events. In view of this, the committee considers that the benefit-risk balance of BNT162b2 remains favourable in the elderly, and does not suggest any revision, at present, to the recommendations around the safety of this vaccine.

Countries should continue to monitor the safety of vaccines, and promote routine after-care following immunization, consistent with good immunization practices for any vaccine. The committee recommends that data on suspected adverse events should be collected and reviewed continuously – nationally, regionally, and globally – as the COVID-19 vaccines are rolled out, world-wide[1].

The GACVS subcommittee will continue to monitor the safety data from these vaccines and update any advice as necessary.

[1] The WHO COVID-19 vaccine safety surveillance manual provides guidance to countries on the safety monitoring and adverse events data sharing for the new COVID-19 vaccines, and can be accessed here.

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