Dr. Martin Feeley served as Clinical Director of the Dublin Midlands Hospital Group until September 2020, when he resigned after the HSE said his criticisms of lockdown made his position “untenable”. In this piece, he sets out his views on the Government’s Covid Vaccination strategy, and asks whether universal vaccination for Covid is appropriate, when compared with the focused vaccination strategy used to control influenza.

You can watch a full interview with Dr. Feeley, conducted by Gript’s Ben Scallan, here.

_________________________________________________________________________________________

 

The announcements of the reported success of the various vaccines in combating Covid-19 last November certainly helped lift the mood of the nation. The vaccines represented the perfect escape from a perceived lethal pandemic and a promise to restore normality.

There is a true sense that many of the population and our political leaders are still of a mind that Covid-19 is universally extremely dangerous and that vaccination is a 100% effective and extremely safe and they are not fully aware of the established facts regarding either the Covid-19 disease or the vaccines.

Vaccination is a health intervention. As such it is subject to the principles of all treatment, the first of which is “primum non nocere” or “first do no harm”. In order to fulfil this a treatment or intervention must be proven to improve outcomes to at least the same degree as best available treatment/s, or better than no treatment if no effective one available. Every intervention must be subjected to a rigorous risk/benefit or cost/benefit analysis. The assessment of Covid-19 vaccines at this point in time is greatly complicated by a number of factors; (a) the widely varying age-related Covid-19 mortality risk, (b) there are multiple vaccines, (c) two of the vaccines have a completely new untried and untested mechanism of action, and (d) none of the vaccines has been subjected to the required rigorous trials legally required to assess safety.

Because of all the reports of significant side-effects caused by vaccines there have been almost daily changes in national and international guidelines and recommendations regarding the administration of individual vaccines. Normally  this would generate an outburst of concern and inquisition from the public and especially from the media. However so complete and deep-rooted is the fear of Covid-19 that the prevailing mind-set is still one of desperation to get the vaccine. So complete is the public belief in the lethality of Covid-19 that nobody asks or seems concerned about the multiple international reports of complications which caused multiple U-Turns and stop/go’s in the vaccination programmes.

In order to apply the “primum non nocare” principle it is necessary to carry out a simple risk/benefit analysis. The absence of certain data due to the fast-tracked nature of the vaccine production might suggest the exercise is not possible: nothing could be further from the truth. The country is effectively engaged in giant scale experimental medicine. We must use the factual data which are available on the most crucial factors necessary in order to make a judgement on the use of a vaccine against Covid-19; this is simply a matter of quantifying the risk from the disease and the benefits and risks from the vaccine.

Covid-19 Risk

The risk from Covid-19 is highly variable yet, paradoxically, quantifiable to a remarkable degree of accuracy.  Thinking of and treating the population as a homogenous Covid-19 risk group, as is done with most measures thus far, is completely illogical. Quoting overall mortality risk is unhelpful and should be avoided when discussing individual disease risk and vaccination. The risk of death is directly related to age and wellbeing; the Centres for Disease Control and Prevention in the US estimates that the risk of death from Covid-19 in those over 85 years-of-age is almost 10,000 times greater than those aged between 5 and 17 years old and the mortality risk doubles every 7.6 years. Mortality risk in healthy children is virtually zero, calculated as equivalent to risk of being struck by lightning.

In Ireland the Health Protection Surveillance Centre (HPSC) reported an underlying medical illness present in over 87% of almost 5,000 deaths from or with Covid-19; Ireland differs from most jurisdictions in that obesity is recorded only if the BMI is ≥40, thus understating the co-morbidity level. Dr Cusack, Kildare County Coroner, reported comorbidity present in 99% of Covid-19 victims with an average of just over 2 co-morbidities per patient. Of those admitted to Irish ICUs 90% had an average of 3.2 underlying medical conditions. The precise risk for any individual can be calculated using a formula such as the Oxford University QCovid calculator.

Vaccine Benefit

The benefits of vaccination with any of the available vaccines are not as accurately quantifiable as is generally believed. The population understanding is based on the November 2020 reports of greater than 90% efficacy; results mistakenly taken to mean prevention of the disease in over 90% of people vaccinated. For the purposes of this article it can be accepted that the vaccines do help reduce severity and incidence of Covid-19. However, it has to be stated that some of the claims made since the roll-out are overstated; the dramatic drop in numbers of PCR positive at the end of January/early February was part of the normal cycle of seasonal virus behaviour, no different to what occurred in April 2020 when there was no vaccine. This type of messaging may be justified in order to reassure an unnecessarily terrorised people.

Vaccine Risks

There have been multiple reports of adverse effects following vaccination. The vast majority of supposed side effects are mild and a natural response to the injected agent. There have been some distressing neurological side effects and allergic reactions which can be serious. More worryingly, there have been a significant number of reports of fatal adverse events. Despite initial assertions that the blood-clot complications were coincidental and not vaccine related it has been established that vaccines can causes changes in platelets which lead to abnormal blood clot formation.

There are 4 vaccines licensed in Europe with two very different production processes and mechanisms of action; Pfizer and Moderna are similar as are Jonson & Johnson and AstraZeneca. The emphasis has been on the thrombosis complication which has been reported associated with all four albeit to different degrees. It should be pointed out that the same risk profile does not necessarily apply to similar products as evidenced by the previously fast-tracked vaccine against Swine Flu in 2009. For the purposes of this discussion the term vaccine is used generically for all 4 vaccines.

The incidence of this vaccine related clotting complication is very low, but the estimates vary widely. In early April the WHOs Global Advisory Committee on Vaccine Safety (GACVS) estimated the incidence at about 1 per million. The European Medicines Agency (EMA) at the same time reported 86 events in 25 million vaccinated; this gives a rate of about 1 in 300,000 which is slightly less than the rate estimated by the UKs Medicines and Healthcare products Regulatory Agency (MHRA) of 1 in 250,000. Norway reported the occurrence of 5 severe clotting problems in health care workers, 32 – 54 years-of-age, 4 females, post vaccination giving a rate of 1 in 26,000 vaccinations. All had the platelet antibody specific which is near conclusive that these were not coincidental but causal. This was reported in the New England Journal of Medicine as was a report from Germany and Austria on 28 positive antibody tests in patients who developed vaccine associated clotting events, details of 11 these patients are reported; aged 22 – 49 years-of-age, 9 females. Of the 16 patients in these two reports 9 (56%) died. It is worth noting that the number of those vaccinated among Norwegian healthcare workers is multiples of numbers in the vaccine trials.

It is hardly surprising that concerns regarding safety have caused numerous interruptions of vaccination programmes, alterations in profiles the of those to be vaccinated and complete U-turns on recommendations.

We know the disease risk varies enormously, as much as a factor of 10,000, but it is unclear if the vaccine risk varies among individuals. The European reports of clotting suggest a predominance in women aged 20 – 55 years old; this may be because of most vaccinations in this age group are in health-care workers, the vast majority of whom are women. However, there have to be concerns that there is a real female gender related risk.

There have been many reports of deaths in the frail elderly, such as the Norwegian report in January of 29 deaths within a few days of vaccination. However, as there is as yet, no confirmation of a causal relationship this cannot be included in this assessment which is based on factual data.

When assessing risk/benefit many look at the overall risk of clotting and the overall risk from Covid-19 and spokespeople for the various agencies such as the EMA and MHHA trot out the mantra, the “benefits greatly outweigh the risks”.  At its mildest this is disingenuous and shows contempt for, not just many in the Healthcare workforce as recipients and vaccinators but the entire population.

The history of fast tracked vaccines should not be forgotten. Because of the fast tracking of these vaccines there are many unknowns. In addition to any possible delayed complications such as those which occurred with the swine flu vaccine there is the complete void of knowledge regarding the effects of mRNA vaccines, particularly in the young.

The Analysis

With this information we now need to compile a risk/benefit ledger for each individual. The most important and best validated factor is the individual mortality risk from Covid-19.

The known risk of serious clot occurrence as shown in 130,000 Norwegian healthcare workers is 0.004%, with a mortality as demonstrated in the Norwegian and German/Austrian reports of about 0.0022%.

The Advice

Even ignoring all other complications including the completely unknown mRNA effects nobody with a Covid-19 fatality risk less than 0.004% should be advised to vaccinate. On seeing this the vast majority of the population will assume that this mandates almost universal vaccination. However, the fact is that nobody under 50 years old with no co-morbidities should be advised to vaccinate. Such is the significance of the co-morbidities that vaccination should be considered in most with significant illness. This is very conservative as the above estimations exaggerate the Covid-19 mortality risk, firstly because the treatment of Covid-19 has improved outcomes and secondly, it assumes everybody gets the disease. Apart from the unknown numbers who have had asymptomatic infection (60%) there is already community immunity due to previous Corona virus infections, estimated at between 20 and 50%. These factors mean that the Covid-19 mortality risk is less than 50% of quoted figures.

It should be pointed out that not vaccinating this cohort of the population does not significantly impact on any benefits of vaccination for the high risk. In fact, vaccination of only the at risk is the norm as with regular influenza.