(updated 18 Jan to reflect new information)
Health authorities in Norway are reporting some concerns about deaths in frail elderly after receiving their COVID-19 vaccine. Is this causally related to the vaccine? Probably not but here are the things to consider.
According to the news there have been
23 29 deaths in Norway shortly after vaccine administration and apparently 13 autopsies had some kind of indication that common vaccine side effects might have contributed. We do not have information on these cases and I can’t imagine how an autopsy would reveal that a person died of a fever, muscle aches, fatigue, or a head ache (the common side effects). The more recent report states:
Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site,…..
Hang on, nausea and vomiting? Those are not side effects of the Pfizer vaccine. In the trials the rates of vomiting were the same in both vaccine and placebo groups.
The mass vaccination of the frailest in our population has always been concerning. Not because of safety but because of the high risk of coincidental adverse events, particularly among persons frail enough to be living in aged care facilities.
Before we launch in to this, keep in mind that in this age group the chances of dying from COVID-19 are around 2 in 10.
About deaths in older people
As we age our risk of dying goes up exponentially (basically it skyrockets) and instead of the usual causes of death in people in their spritely fifties and sixties it is more likely related to the failure of body functions (basically we clap out). It is true that minor things can hasten a departure from the mortal world in a very frail older person.
How many deaths occur every day?
Of course it is easy to calculate this for any country by dividing the annual deaths by days of the year. This is pretty crude and if we only consider older folk there will be more deaths in the winter months as viruses such as flu wreck havoc.
In Norway, based on 2019 data, 13,150 persons aged 80-89 and 10,057 persons aged over 90 years died, an average of 446 persons per week and 64 person a day in the very elderly.
In NZ there were 17,583 persons over 80 who died that year, an average of 338 per week and 48 per day.
So, everyday nearly 50 very elderly people die in NZ and over 60 in Norway.
COVID-19 vaccination in Norway
Norway began vaccinating 27 December and are first vaccinating residents in nursing homes and selected health care personnel. That is being followed by age 85 years and above and further selected healthcare personnel. As of 15 Jan 2021 around 42,000 doses had been administered.
COVID-19 vaccines and deaths – experience so far
Just considering the Pfizer vaccine for now, during the Phase III trials deaths occurred in both vaccine and placebo recipients. All deaths were the kinds of things that occur in the general population of the age groups where they occurred, at a similar rate.
There were a total of six (2 vaccine, 4 placebo) of 43,448 enrolled participants (0.01%) died during the reporting period April 29, 2020 (first participant, first visit) to November 14, 2020 (cut-off date). Both vaccine recipients were >55 years of age; one experienced a cardiac arrest 62 days after vaccination #2 and died 3 days later, and the other died from arteriosclerosis 3 days after vaccination #1. The placebo recipients died from myocardial infarction (n=1), hemorrhagic stroke (n=1) or unknown causes (n=2); three of the four deaths occurred in the older group (>55 years of age).
Since deployment of COVID-19 vaccines in the United States as of 9 Jan 2021 11 deaths following administration of the Pfizer and Moderna vaccines. Almost all of these deaths were in persons over 80 years of age and residing an aged care facilities. None are considered related to receipt of vaccine. (See here for ongoing spontaneous reporting in the US
Vaccine reactogenicity in older people
There is some concern in Norway that the reactogenicity (common reactions like fever) associated with the vaccines is too intense for the frail elderly. Is this possible? I generally doubt it, particularly as nausea and diarrhea are not reactions to this vaccine.
Systemic events, those that affect the general body rather than the injection site, were generally increased in frequency and severity in younger age groups compared with older age groups. This is because these are related to an immune response and generally older people do not respond as intensely. The systemic events across all vaccines authorised at this stage are generally fatigue, headache, muscle pain, chills, joint pain, fever. In other words, flu-like symptoms that are fairly non-specific to many infections. Vomiting and diarrhoea were reported at similar rates between vaccine and placebo groups. The median onset day for most events after either dose was day 2-3 and they lasted a day or two. Among 65-85-year olds in the Phase 1,2 systemic events were uncommon with only muscle pain reported as severe in a few people. There was no severe fever reported in this age group.
The point here is that generally speaking the older the person the less reactogenic the vaccines.
The importance of background rates
It is vital that every country that has the capability should prepare baseline rates of possible adverse events, including deaths. Without this data it will be very difficult to determine if we are seeing more cases that we should expect without the vaccine. Most countries are not yet well prepared with this data and would do well to get a wriggle on, there is a fair bit of work required to extract and analyse this data so that it is meaningful and useful. Bureaucracy and funding barriers were overcome to develop vaccines at phenominal speed but in my opinion this has not extended into the issues of deployment. This reporting from Norway illustrates the absolute urgency to get this done. Are NZ ready? No.