January 18, 2021

expert reaction to reports that Norway are investigating several deaths in frail elderly patients after vaccination with Pfizer’s COVID-19 vaccine

There have been reports that Norway is investigating deaths of several frail elderly patients after receiving the Pfizer/BioNTech COVID-19 vaccine.

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:

“All medicines, including vaccines, have to consider the balance of benefits and harms. For vaccines this is particularly true since they are used in prevention rather than treatment of disease.

“With vaccines that are given to healthy people, then any possible harm must be clearly offset against clear benefits. We have had experience of giving flu vaccinations to elderly, and often frail and unwell people. They are vulnerable to flu.

“With Covid we know that the risks of death if you get the disease rise very dramatically with age. The very elderly are most at risk of death. In a context where there is a lot of the SARS-CoV-2 virus about, it is vital that the elderly are as protected as possible.

“When we vaccinate people at high risk of death then there will be a certain number of coincidental deaths that occur shortly after vaccination. It is possible, in a particular context, to calculate the “expected number” of deaths within various time periods, and this will be done routinely by most regulatory authorities monitoring the safety of vaccines. It is vital that this monitoring is done and it is done well in the UK, the EU and the US among other countries. We do not yet know, but it would seem that the observed numbers of deaths is not notably above the numbers expected, but this will need to be examined continually in all countries where it can be done. So far, there is no evidence that any link between vaccination and death in these vulnerable patients is a causal one.

“It is reported that The Norwegian Institute of Public Health judges that “for those with the most severe frailty, even relatively mild vaccine side-effects can have serious consequences. For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant.”

“This is in the context of Norway where recently they seem to have less than an average of 1000 cases reported per day and less than about 25 deaths per day. The UK has recently had more than 1000 deaths per day and about 50,000 cases. The UK numbers are about 50 times higher for a population that is about 12 times higher.

“We can be assured that the UK authorities will be monitoring this carefully and will issue amended advice if necessary. It is possible that there could be differences between vaccines if there were to be evidence of a causal association, and if so, this will also be investigated.

“Overall, there is no need for anxiety, but complacency is equally mistaken. It illustrates what has been said that we will need different vaccines in case the experience in widespread use shows that some are more suitable for some groups of people than others.”

Eg. https://www.bmj.com/content/372/bmj.n149

Declared interests

Prof Stephen Evans: “No conflicts of interest.  I am funded (one day per week) by LSHTM.  They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them.  I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI.  I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs.  I am a participant in the Oxford/Astra Zeneca trial, and on 13^th January 2021 learnt I had received the active vaccine”