Covid-19: Norway investigates 23 deaths in frail elderly patients after vaccination

Abstract

Doctors in Norway have been told to conduct more thorough evaluations of very frail elderly patients in line to receive the Pfizer BioNTec vaccine against covid-19, following the deaths of 23 patients shortly after receiving the vaccine."It may be a coincidence, but we aren't sure," Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA), told The BMJ. "There is no certain connection between these deaths and the vaccine."The agency has investigated 13 of the deaths so far and concluded that common adverse reactions of mRNA vaccines, such as fever, nausea, and diarrhoea, may have contributed to fatal outcomes in some of the frail patients."There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly," Madsen said. "We are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease," he emphasised. "We are now asking for doctors to continue with the vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it." This evaluation includes discussing the risks and benefits of vaccination with the patient and their families to decide whether or not vaccination is the best course.

Untimely Myocardial Infarction or COVID-19 Vaccine Side Effect

“…While Moderna considered these side effects minor, they could be significant stresses for older adults, especially those with preexisting comorbidities. In Norway, there was concern that the Pfizer vaccine was associated with increased mortality in older adults with 23 deaths, and investigation into these deaths suggested some of the listed side effects above might have caused the death of "frail patients" [7]. According to the CDC, there have been greater than 1,100 reports of death after the COVID-19 vaccine, with no indication of a link to the vaccine [8].…”

Considering Frailty in SARS-CoV-2 Vaccine Development: How Geriatricians Can Assist

“…Examples include management of comfort during vaccination, potential for reactogenicity in already frail vaccine recipients (although evidence from COVID-19 and other vaccines suggests that reactogenicity tends to be lower with increasing age and frailty), 13,[30][31][32]55 and concerns about serious adverse events occurring in the setting of a population with high background events. 56 This age-and frailty-specific communication is important to help inform and guide immunization practice across settings; integrating this messaging within primary care is particularly essential, and geriatricians are likely to have existing collaborative relationships with primary care and long-term care clinicians. Again, trust is important -although vaccine hesitancy is generally lower among older adults, it is present in the older age groups and also among substitute decision makers (SDMs) and LTCF staff who engage with older persons with cognitive impairment, impacting decision-making capacity to make vaccination decisions.…”

Mortality Rate and Characteristics of Deaths Following COVID-19 Vaccination

“…The emergency use authorization for coronavirus disease 2019 (COVID-19) vaccines brought both hopes and concerns to the Americans and others. Most recently, the Norwegian Medicines Agency reported 29 deaths following COVID-19 vaccines in very frail elderly patients, raising safety concerns for vaccination in older adults (1). Norwegian government has adjusted advice on who should receive COVID-19 vaccines which are based on novel messenger RNA (mRNA) technology.…”