“It is a huge responsibility to impose a medical intervention on a healthy person who may not directly benefit from it, and who may be made sick by it...”
The UK government recently ran a public consultation about vaccinations for the Corvid virus. Dr Elizabeth Evans has kindly offered her response for TAC Bulletin readers. She wrote as follows:
Please find below my concerns/comments:
NATURE OF THE CONSULTATION
- I would argue that it is not COVID-19 that is "the biggest threat this country has faced in peacetime history" but instead the threat comes from the draconian measures the UK Government has chosen to take which are disproportionate to the actual threat to public health from COVID-19. With a current total of around 800,000 deaths worldwide and a case fatality rate (CFR) of 0.26% (CDC estimate), Covid falls well behind the Spanish Flu (1918) 40-50 million deaths worldwide, CFR >2.5%; Asian Flu (1957-58) 1-4 million deaths worldwide, CFR 0.67%: Hong Kong Flu (1968) 1 million deaths worldwide (many young people), CFR <0.5%.
- The statement that an effective COVID-19 vaccine is the "best way to deal with the pandemic" is highly subjective and not supported by evidence. Looking at the UK daily deaths curve, which is now a classic inverted bell shape which obeys Farr's Law, would suggest the epidemic in the UK and many other Northern Hemisphere countries, has almost run its course, and that a vaccine is no longer needed. The reported "spikes" in cases (positive test results as opposed to symptomatic people) are not leading to increased hospitalisations or deaths which would suggest that either the virus has become less virulent so no longer constitutes the threat to public health that it did in March-May, or that we now have a good level of immunity in the population and those picked up on testing are asymptomatic "healthy" people who have eliminated the virus when exposed without becoming ill or infectious. Both would mean that rolling out an experimental and unlicensed vaccine would not be justified, as the risk of vaccine side-effects would now outweigh any benefit.
TEMPORARY AUTHORISATION OF UNLICENSED PRODUCTS
- The JCVI are able to recommend using an unlicensed vaccine against Covid, This is problematic as the head of the JCVI is Professor Andrew Pollard who is also the Director of the Oxford Vaccine Group, who are working with Astra Zeneca on their Covid Vaccine. This is a blatant and unacceptable conflict of interest and he should be asked to step down as his role of JCVI Chairman for the duration of the pandemic. It also must be remembered that Professor Pollard was the Chair of the JCVI who passed the Pandemrix vaccine as safe for children in the 2009 Swine Flu "pandemic". This was a catastrophic decision for the 1300 children who suffered permanent neurological damage, in the form of the life-changing condition narcolepsy, as an unexpected side-effect from the Pandemrix vaccine, which was the hastily withdrawn. We must learn from this lesson and not risk more injury/death to be caused, especially to those who are at almost no risk from Covid, from a inadequately tested and rush-out vaccine.
- The definition of a "safe and effective vaccine" needs to be clearer. Regarding safety - what will an acceptable level of risk of death or serious side effects be? It must be significantly safer than the risk from Covid for each age group the vaccine is given to. It is known that the risk of dying from Covid for 4-15 years is around 1 in 3,000,000. The limited safety studies any vaccine will have undergone will not be able to pick up serious adverse events or deaths at a rate of much less than 1 in 10,000 due to the short duration of the trials and the number of participants in the trials being under 100,000. What level of efficacy will be considered worthwhile in the face of the inevitable risks? It is worth remembering that Covid has a 99.74% survival rate, and those people will have immunity at least as good and long-lasting as a vaccine as natural infection always gives longer-lasting immunity than vaccines. The WHO is talking about vaccine efficacy needing to be >50%. This would leave 50% of people vaccinated unprotected but who will have been exposed to the risk from the vaccine. It is also not clear whether a vaccine would be considered as a candidate if it only reduced the severity of symptoms but did not prevent transmission - allowing the vaccinated to still contract and transmit the virus to others. If this is the case, the risk:benefit analysis does not come out in favour of rolling out an unlicensed vaccine. We already know that the Astra Zeneca vaccine was temporarily halted when one of the 30,000 participants developed the serious inflammatory, paralysing condition, transverse myelitis, which is a known side effect of several vaccines including the influenza vaccine and the Hepatitis B vaccine. If a serious and permanently disabling condition like this occurred in one in every 30,000 doses this would lead to thousands of life-changing injuries from the vaccine if the whole population were to be vaccinated.
- In "balancing risks and benefits to patients" of an unlicensed vaccine it is imperative that the risk of Covid to different groups in the population is considered. We now know that the whole population survival rate from Covid-19, from the latest data (CDC and others), is around 99.74%, with rates of 99.99+% survival for under 50s. The risks of the vaccine could therefore be greater than the risk from Covid-19 for a considerable section of the population. All medicines and vaccines will have side effects - even if rare - which can be devastating to those unfortunate enough to be affected. These occur even when vaccines are extensively trialled. In the UK we have a Vaccine Damage Payment Scheme run by the government to compensate people damaged by vaccines - an admission that they are not 100% safe - which has paid out millions of pounds to victims of vaccinations over the last 20 years. In 2011, the US Supreme Court ruled that vaccines are "unavoidably unsafe". Even vaccine companies have never claimed that vaccines are 100% safe - listed on the package insert for every vaccine is a long list of potential side effects listed, from the very minor to brain damage and death. In the US, pro-vaccine experts like Prof Peter Hotez and Paul Offit are cautioning against a rushed vaccine, and history is littered with examples of damage caused by rushed vaccines. This is a sobering article from the Telegraph outlining incidents when serious vaccine side-effects only became apparent after a vaccine was rolled out to the population, which then had to be hastily withdrawn e.g. Dengvaxia, Pandemrix, RotaShield, RSV vaccine, 1976 Swine Flu Vaccine, https://www.telegraph.co.uk/news/2020/07/26/risk-uncertainty-fear-failurewhy-scientists-arent-celebrating/
CIVIL LIABILITY AND IMMUNITY
- Given the proposed immunity from liability for the pharmaceutical companies, manufacturers and healthcare workers administering the Covid vaccine, it appears that the only risk will be shouldered by the public, who are not included as named stakeholders in the consultation. This is unacceptable as their lives could be negatively impacted permanently if death/injury occur to them or their children, as a side-effect from the vaccine. Not all vaccines are created equal and some are riskier than others. The existence of benefits from a vaccine does not mean we should ignore the damage and harm that may be caused to a few. These individuals should not be treated as acceptable "collateral damage" for the greater good. If the vaccine companies are immune from liability for injury and death caused by their vaccines, who will pick up the tab if people are injured, as happened with the Pandemrix jab? Will any Covid vaccine be listed in the UK Government Vaccine Injury Payment Scheme so that those injured can claim? It is completely unacceptable that the UK Government has already agreed to protect the pharmaceutical companies from any financial risks to them from injury/death caused by their product, but seems unconcerned about the public being exposed to the implied risk of injury/death.
- The Government appears more concerned to protect the profits and finances of the pharmaceutical companies than the health of the public. Exempting "key actors in the medicine supply chain" (doctors, nurses, and manufacturers) from liability for injury or death from an unlicensed vaccine does nothing to give the public confidence in the vaccine or to compensate those who will be harmed. The average time for a vaccine to be trialled before marketing is 7 years, which gives time for participants to be followed up for a few years to look for any increase in chronic conditions which may indicate a long-term side-effect of the vaccine. Science cannot be rushed safely, there is logically no way to look for long-term side effects if a vaccine is rushed through in a year or less. This has been admitted openly by the vaccine companies, who have demanded immunity from liability before rolling out any coronavirus vaccine, including Astra Zeneca, whose spokesperson is on the record as saying, "This is a unique situation where we as a company simply cannot take the risk if in.. 4 years the vaccine is showing side-effects"
- If the Government is looking to remove all civil liability, for side effects/deaths caused by the vaccine, from vaccine companies and also from professionals administering the vaccines, this will leave nowhere for the victims of vaccine injury to go to obtain compensation. This is a concerning development as we know, from past experience of all vaccines, but particularly the Pandemrix vaccine which was rushed out during the swine flu "pandemic" in 2009 and which led to over 1300 cases of narcolepsy (a permanent and life-changing neurological condition) in children and teenagers across Europe. Some victims were eventually compensated by the Government for damage and the long-term care they would require, but others are still fighting for compensation. It is not clear if the Government is planning any compensation scheme for an unapproved Covid vaccine, if it is rushed out before regulatory approval or long-term safety studies have been carried out. The Government exists to protect the population, not the profits of big companies like the pharmaceutical industry.
VACCINATORS WHO ARE NOT REGISTERED HEALTHCARE PROFESSIONALS
- As a former doctor, I am concerned about the prospect of unqualified people undertaking what is a medical procedure. This would place the public at risk if there were to be immediate, unexpected, serious reactions (e.g. anaphylactic shock) that requires urgent medical intervention.
- Using vaccinators who are not doctors or nurses would also jeopardise the obtaining of proper, informed consent, which is essential for any medical procedure which carries risk. For a patient to give informed consent they need to understand the individual risks and benefits of the vaccine, which will be different for different patients depending on age, sex, comorbidities etc. The process of explaining the risks and benefits is a specialised task that requires a good degree of medical knowledge. It is a huge responsibility to impose a medical intervention on a healthy person who may not directly benefit from it, and who may be made sick by it, therefore it must be done with fully informed consent.
- Doctors are taught that their professional responsibility is to "First, do no Harm". The desire to rush out a vaccine must not be done in a way that cuts corners and puts the public at risk.
- If short/medium/long-term vaccine side effects are suffered by a patient, who will be the clinician responsible for looking after the patient and where will the patient go to obtain support and compensation?
- I am uneasy with the idea of adverting being allowed for this product. Advertising is by nature marketing, not science, and rarely gives a balanced view of risks and benefits. Given that a Covid vaccine would essentially still be an experimental vaccine when released on the population, there should be no pressure put on any member of the public to have the vaccine or any restrictions put on people who choose not to accept the risk of a vaccine who's long term side effects will be completely unknown and untested (infertility, autoimmune diseases, chronic fatigue, neurological disorders, cancers etc are all possible and documented long-term effects from vaccines)
- I understand that there is no provision in the Coronavirus Act to make a coronavirus vaccine mandatory but I am concerned that there will be an attempt to coerce the public into taking the (unlicensed and inadequately tested) vaccine by imposing restrictions on their ability to live a normal life - travel, schooling, jobs, etc. I find the idea of coercion to take a vaccine deeply disturbing. It is naive and simplistic to believe that one approach/treatment can work for all, with no exceptions. For most people, vaccines will cause no obvious or serious harm - and this is reflected by the 90%+ take-up of vaccines in general. However, for a small but significant minority of individuals (who may be genetically predisposed to a lower tolerance of the ingredients in vaccines, or who may have other underlying health conditions, or for other reasons medicine and science do not yet understand) vaccines may cause serious and devastating harm. It is therefore imperative that people have the right to choose for themselves and their children, as they are the ones who have the most to lose if injury or death occurs. We now know that the whole population survival rate from coronavirus, from the latest data (CDC and others), is around 99.74%, with rates of 99.99+% survival for under 50s. The risks of the vaccine could therefore be greater than the risk from the disease for a considerable section of the population.
- Unless or until vaccines are guaranteed 100% safe by the manufacturers, the government should never seek to mandate their use or restrict the freedoms of people who choose not to have them. Giving a government the authority to effectively inject whatever they deem desirable into the public would lead to a frightening loss of autonomy for all people over their own bodies, and the loss of the fundamentalright to freedom of informed medical consent. Thiswould effectively create a medical dictatorship. It is a huge responsibility to impose a medical intervention on a healthy person who may not directly benefit from it, and who may be made sick by it, therefore it must be done with fully informed consent, allowing dissenters
Dr Elizabeth Evans MA(Cantab), MBBS(Lond), DRGOG - retired doctor.