The committee published its opinion today (January 22) after reviewing deaths following vaccination with BNT162b2 in this demographic in Europe as well as those reported via the WHO global database (VigiBase). Norway, in particular, had reported 23 deaths in elderly people following vaccination.
“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,” says a statement from the committee, following the review with experts from the European Medicines Agency and Uppsala Monitoring Centre.
“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.”
The WHO listed the vaccine for emergency use on December 31: saying it met its must-have criteria for safety and efficacy.
Norwegian authorities reach similar conclusion
Many countries are prioritizing vaccination of care home residents in the initial roll-out of vaccines: given this population is more likely to suffer severe forms of COVID-19 resulting in hospitilization or death.
Last week, the Norwegian Medicines Agency reported it was investigating 23 deaths which occured among elderly people in nursing homes within a week after vaccination. The Norwegian Ministry of Health and Care Services, however, yesterday stated there was no cause for concern over the safety of the vaccine (noting that, on average, more than 300 elderly people die in Norwegian nursing homes every week).
The Norwegian Institute of Public Health (NIPH) states fatal incidents among these severely frail patients following vaccination do not imply a causal relationship between COVID-19 vaccination and death; adding that there are no statistical analyses that indicate vaccination has increased the risk of death.
“The reported deaths are among elderly, very frail patients and nursing home residents in the end-of-life phase. This does not give cause for concern for the safety of the vaccine", said Bent Høie, Minister of Health and Care Services.
The GACVS subcommittee will keep monitoring safety data and says data on any suspected adverse events should continue to be collected and reviewed. In Norway, both healthcare professionals and the public can report any suspected side effects electronically.