Vaccine season again. Flu is likely to be a problem this winter and it is essential that all those eligible get their flu jab as soon as possible. Vaccination generally is an incredibly effective public health intervention. We were all convinced with the miracle that was the Covid19 vaccine programme but, as we jab patients for the 5th time with a vaccine that has had little modification since introduced in December 2020, perhaps we need a proper critical assessment of real world safety and efficacy data. Yes the new version of the Moderna vaccine is now bivalent that is it contains mRNA from the B1 version of the virus along with the Wuhan wild strain yet the evidence base for the Emergency Use Licence amounts to a study in 460 patients at a time that virus prevalence was low. The bivalent Pfizer vaccine may only have been tested on mice.
Aseem Malhotra, a cardiologist and evidence-based medicine expert, raised concerns following his father’s sudden death due to a heart attack. For Aseem a fatal heart attack only a few months after a clean bill of health was a puzzle. Could there be a link to his father’s two Pfizer vaccines in the Winter/Spring of 2021? This was a puzzle he decided to address and in September published two papers in the Journal of Insulin Resistance suggesting that the safety of the Pfizer Covid19 vaccine needed to be more critically assessed and in particular its potential role in cardiac side effects and possible deaths.
Aseem’s paper postulated a link between the Pfizer vaccine and an increased risk of CHD. To many Aseem might appear an over-zealous son doing what he can to understand the tragic loss of his father and to some extent he may feel guilty he didn’t do more. An anecdotal report, certainly on its own proves nothing; no association and certainly no proof of causality.
However, and completely independently, there is now concern that we are experiencing a persistent and sustained increase in excess deaths across the globe and these excess deaths have been happening since April 2022. They are not a statistical blip but indicate a real phenomenon that needs explanation.
More importantly, these additional deaths are not due directly to Covid19 infection. They are unexpected deaths occurring in younger than expected age groups. For Spain, Greece and Cyprus these excess deaths –more deaths than would be expected taking into account the 5 year average – were 37%, 31% and 35% respectively across the summer months. In the UK the figure is above 10% and might be has high as 16% and in Ireland the rate is more than 15%. In Australia, it is 17%. These are big numbers of people dying that otherwise, we would not expect to die.
Several possible reasons are actively being investigated. They might relate to the impact of post-Covid complications. We know that about 10% to 20% of those who contract the virus suffer from long-covid with specific impact on the respiratory system and the CNS. There is also the impact of lockdown, which includes less access to healthcare and delayed diagnosis which potentially could cause additional deaths. And off course Europe had a significant heatwave in the Summer of 2022 that we know increased the death rate. Yet if we look at the causes of deaths we find that cardiac events are by far the most frequently cited reason.
Aseem Malhotra’s main point is that even suggesting a link between CHD deaths and the mRNA vaccines is viewed as bordering on criminal. He points out that critical appraisal of safety data on mRNA vaccines was seen, and still is seen, not as it should be; an essential part of the scientific process but, as anti-vaxxer sentiment that will only serve to support the crack-pots who are hell-bent on stopping any form of vaccination. It is unacceptable that safety data on these vaccines are not yet freely available to the research community.
I will continue to support the vaccination programme for Covid19 yet I find I am being biased by one paper and conflating it with the reports of excess deaths. The lack of transparency on vaccine safety data would solve this. Yet, given the current prevalence of less dangerous virus strains, vaccines may only have more benefits than risks in much older patients and probably not in those under 50 years.
Editors note: To confirm, Terry is not suggesting you should avoid vaccines. Terry administered the covid vaccine and booster to myself and my wife. It is good science that we should look at all the data, and just because you ask questions does not make you an anti-vaxxer. Brian
I am a pharmacist in Belfast.