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Covid-19 Vaccines; How Safe And Efficacious Are They?

By Terry Maguire - 01st Nov 2022

vaccines

We can ask objective scientific questions about the safety and efficacy of the Covid-19 vaccines and potential side-effects without being ‘anti-vaxxers’, writes Terry Maguire.

Vaccine season again. Community pharmacists in Ireland have been commissioned to provide seasonal flu vaccines and booster Covid-19 vaccines this autumn and winter. The cohort we are targeting is patients over 50 years. In addition to being an important service for the pharmacy network, it is also an important income stream. We were all convinced by the miracle that was the Covid-19 vaccine programme but, as we jab patients for the fifth time with a vaccine that has had little modification since introduced in December 2020, perhaps we need a critical assessment of real-world safety and efficacy data. So, I thought to myself, are there any emerging concerns beyond those of the lunatic fringe of anti-vaxxers? This is what I found. 

I never met Dr Kailash Chand, but I knew of him as Deputy Chair of BMA and a staunch and vocal supporter of the NHS. He died suddenly in July 2021 following an unexpected heart attack. He was in his early 70s and apparently in good health. Indeed his son, Dr Aseem Malhotra, a well-known cardiologist and evidence-based medicine expert, had assessed his father’s cardiac status a few months before and found excellent coronary blood supply. For Aseem, a fatal heart attack only a few months after a clean bill of health was a puzzle. This was a puzzle Aseem decided to address and in September 2022, he published a paper in the Journal of Insulin Resistance in which he suggested that the safely of the Pfizer Covid-19 vaccine needed to be more critically assessed and in particular, its potential role in cardiac side-effects and possible deaths. He wondered if his father’s sudden CHD death might be linked to the two Pfizer vaccines he received Spring 2021. 

So, I thought to myself, are there any emerging concerns beyond those of the lunatic fringe of anti-vaxxers?

My interest in Aseem’s paper was piqued by an identical personal experience, yet I had never considered any role for the vaccine in my heart attack. I had a stent so, unlike Dr Chand, had existing heart disease but my stent was stable until the early summer of 2021, at which time I too had got two Pfizer vaccines, one in January and one in March. When I had a heart attack in September 2021, it was six months from my last vaccine, just like Dr Chand. My heart attack was due to a failure in the existing stent, which effectively clotted up. This is a very rare event. There was no progression of arterial disease in other regions of my coronary arteries. 

Aseem’s paper postulated a link between the Pfizer vaccine and an increased risk of CHD. A paper he cites, published in November 2021, showed that in a cohort of 500 CHD patients, their CHD risk doubled from 11 per cent risk of an event in the next five years, to a 25 per cent risk, mainly due to an increase in inflammatory markers associated with an increased CHD risk. 

In the pivotal Pfizer study on its mRNA vaccine, in data on which an Emergency Use Licence was based, there were four cardiac events in the vaccine group compared to one in the control group. Small and statistically insignificant, but nonetheless a signal, and there is now evidence that serious ADRs were under-reported by study participants. Myocarditis was the most common side-effect noted, mostly in young adults, with relatively high rates identified in Israel and Hong Kong in independent studies. There is now an established causal link between mRNA vaccines and myocarditis. 

In the UK, the MHRA Yellow Card scheme that is used to monitor safety post-licensing had 500,000 adverse events reports from 150,000 individuals. MHRA do not distinguish between serious and non-serious Yellow Card reports but Norway does, and their data shows that one-in-1,000 patients after two Pfizer vaccine doses was hospitalised or had life-changing issues. 

A paper in Nature revealed a 25 per cent increase in both acute coronary syndrome and cardiac arrest in young people and linked these to the administration of the first and second doses of the Pfizer vaccine. The mRNA technology to produce the Covid-19 vaccine is new and very different to traditional vaccine technology, so it cannot be taken at face value as safe. In this technology, also used by Moderna, mRNA is inserted into cells to manufacture proteins on the cell surface that mimics the spike proteins on the SARs-CoV-2 virus. This activates and stimulates an immune response that provides immunity. 

To many, Aseem Malhotra may just seem to be 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. My similar experience, again only 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, and are certainly not a statistical blip but indicate a real phenomenon that needs explanation. 

More importantly, these additional deaths are not due directly to Covid-19 infection. These 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 five-year average — were 37 per cent, 31 per cent and 35 per cent, respectively, across the summer months. In the UK, the figure was 16 per cent and in Ireland, the rate is more than 15 per cent. These are big numbers of people dying that otherwise we would not expect to die. 

A number of possible reasons are actively being investigated. They might relate to the impact of post-Covid complications. We know that about 10-to-20 per cent 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 of course Europe had a significant heatwave in the summer of 2022 that we know increases 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 to even suggest a link between CHD deaths and the mRNA vaccine is considered bordering on the criminal. Such has been the caution around making false statements about the vaccines that any dissent is viewed as being ‘anti-vaccination’. He rightly points out that critical appraisal of safety data on mRNA vaccines, was seen, and still can be 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 crackpots who are hell bent on stopping any form of vaccination. 

I will continue to support the vaccination programme for Covid-19, but I find I am being biased by one paper and conflating it with reports of excess deaths. Yet, given the current prevalence of less dangerous strains of the virus, vaccines may only have more benefits than risks in older patients. With the booster vaccination cohorts targeted this winter, perhaps Government advisers are also seeing this. 

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