“The UK Currently Operates a System of Informed Consent for Vaccinations.” Currently, Minister?

Dr Helen Westwood, a GP whose previous letters and comments have appeared on Lockdown Sceptics, wrote to her MP Sir Graham Brady in March with some concerns about the vaccines and the potential for coercion. She has now received a reply from Vaccines Minister Nadhim Zahawi that is far from reassuring.

Here’s what she wrote.

Dear Sir Graham, 

Firstly I wish to thank you again for your ongoing hard work in arguing for a more proportionate response to dealing with COVID-19.  The concerns I wish to raise with you today relate to the vaccination program and the proposition of vaccination certificates.

As you know I am a GP. I am horrified by the talk of ‘No Jab, No Job’ policies and vaccination certificates.

The GMC are very clear that “all patients have the right to be involved in decisions about their treatment and care” and that “doctors must be satisfied that they have a patient’s consent… before providing treatment or care”. They also state “doctors must… share relevant information about the benefits and harms of proposed options and reasonable alternatives, including the option to take no action”.

Following interim analysis of the ongoing clinical trials, emergency use authorisation has been granted by the MHRA for both the Pfizer BioNTech and the AstraZeneca vaccines. They are as yet unlicensed. The clinical trials are due to continue until 2023. I find it alarming that much attention is paid to the headline figures of relative risk reduction (RRR) with no mention of the absolute risk reduction (ARR). The RRR of the Pfizer BioNTech vaccine is 95.1% (CI 90.0%-97.6%, p=0.016). Dig a little deeper into the data and you learn that the ARR is only 0.7% (CI 0.59%-0.83%, p<0.001) and the number needed to vaccinate in order to prevent one infection is 142 (CI 122-170).

The WHO published a bulletin written by John Ioannidis, Professor of Medicine at Stanford University, in October 2020. He quotes an infection fatality rate (IFR) for Covid of 0.00-0.57% and in those under the age of 70 it stands at 0.05%.

Given the minimal risk healthy people under the age of 70 face, and the very small absolute risk reductions noted in the clinical trials, I have to ask why are we so desperate to vaccinate the whole population? For healthy, working age people Covid poses less of a risk than seasonal flu. It has never been proposed that we vaccinate the entire adult population against flu; we target the populations most at risk.

The speed at which these vaccines have been developed is truly remarkable. However, I have grave concerns that they are being rolled out on such a scale and at such pace. I am not sure whether you are familiar with the work of Joel Smalley MBA (a member of HART) but he has done some very interesting analysis of mortality data. Whilst correlation (between vaccination administration and rises in mortality) absolutely does not mean causation, the striking patterns he has highlighted suggest to me that now is the time to pause and reflect on the data we have so far. We know from the clinical trials that the Pfizer BioNTech vaccine causes a drop in lymphocytes around seven days post administration; theoretically at least this could pose a risk of intercurrent infection, especially in frail patients. 

Both vaccines in current use in England employ novel technology, namely mRNA (Pfizer BioNTech) and Adenovirus vector (AZ). Human challenge studies have only recently begun. We do not currently know anything about the medium and long term safety of these vaccines. There are concerns about Antibody Dependent Enhancement (ADE) reactions whereby vaccinated individuals may develop more severe disease upon exposure to the wild virus. Theoretical concerns have also been raised about potential cross reactivity with Syncytin-1 which could have effects on placental development and therefore fertility. Until these areas have been studied we cannot advise patients fully. This has significant implications for the informed consent process.

There seems to be some enthusiasm for “vaccination passports” among the population, whether for domestic use or international travel. These have been compared to Yellow Fever certificates that are required for individuals travelling to certain destinations. In reality there is no comparison. The mortality rate for Yellow Fever is in the region of 30%, transmission of Yellow Fever is confined to a relatively small number of countries and there are long term safety data available regarding the licensed vaccine.

Uptake of the Covid vaccine has been notably lower amongst certain ethnic minorities. The reasons for this are as yet unclear, but any policy requiring proof of vaccination has the potential to lead to indirect discrimination.

Professor Chris Whitty has said that doctors and care workers have a “professional responsibility” to get vaccinated. Given that reduction of transmission is not an outcome that is being measured in the clinical trials that are still ongoing, I do not agree with him. Article 6 of the Universal Declaration on Bioethics and Human Rights states: “Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.”

On November 4th 2020 Theresa May MP made a speech in the House of Commons. She was referring to the closure of places of worship when she said, “My concern is that the Government today making it illegal to conduct an act of public worship, for the best of intentions, sets a precedent that could be misused by a Government in future with the worst of intentions, and that has unintended consequences.” I fear the same could be said for the introduction of vaccination passports.

Personally I have declined this vaccine because of the concerns outlined above. I hope this decision does not mean I am unable to work, visit a restaurant or travel.

Yours sincerely,

Dr Helen Westwood

Here is Nadhim Zahawi’s response, passed on to Dr Westood by Sir Graham Brady.

This is how Dr Westwood replied this week.

Dear Sir Graham, 

Thank you for sending me the letter you received from Nadhim Zahawi MP, Minister for Business and Industry & Minister for COVID Vaccine Deployment in response to the representations you made to him on my behalf. I have attached his letter and my original email.

I must say I find his responses entirely unsatisfactory. He has failed to address any of my concerns. I know he is an intelligent man, so I can only assume that he has been deliberately disingenuous rather than not understanding the questions posed.

I am already aware of the processes involved in the development and testing of new drugs. I understand that Phases 2 and 3 are usually run sequentially but, given the urgency of this situation, a pragmatic decision was taken to run them in parallel. For elderly patients at increased risk from COVID-19 infection I can understand this approach. However, when the program is being rolled out to younger, healthy individuals whose risk-benefit ratio is entirely different, an alternative approach is required. It is imperative that individuals are not exposed to a greater risk of harm undergoing a medical intervention than the risk of not doing anything. Primum non nocere. Since my original email, significant concerns have been raised in a number of European countries about the risk of rare cerebral venous sinus thromboses associated with thrombocytopenia. Young, fit, healthy people who were at negligible risk of COVID-19 have tragically died.

Mr Zahawi has elected not to make any comment on the concerns I raised regarding rises in mortality in the immediate post-vaccination period. This is a pattern that has been repeated in multiple locations, currently most notably in India. I would like to know what research is being done by the UK Government to investigate this.

I note that Mr Zahawi referred to the fact that the UK “currently operates a system of informed consent for vaccinations”. I have two concerns regarding this statement. Firstly, how is the consent fully informed if we do not know the answers to the questions I have raised? I know from first hand experience that individuals attending for Covid vaccinations are not routinely being informed that the clinical trials are ongoing until 2023. Nor is the potential issue of antibody dependent enhancement being discussed. The advice for vaccinating pregnant women changes virtually day by day. Secondly, why does he need to use the word “currently”? Are there plans for mandatory vaccination in future? Already there are discussions about making vaccination compulsory for care home workers. In September 2019 the Guardian reported that Secretary of State for Health Matt Hancock was seriously considering making vaccinations compulsory for state school pupils. I defy anyone not to find this proposal chilling.

With regard to black, Asian and minority ethnic populations, again Mr Zahawi seems to have entirely missed my point. I was not arguing for the prioritisation of these groups; I was pointing out that uptake in these groups has been lower and therefore any certification system has the potential to lead to indirect discrimination.

I agree with Mr Zahawi that an effective vaccine is an excellent way to protect those that need protection, but it also needs to be safe. Given his failure to address the concerns I raised I can only assume he does not have answers to my questions.

Yours sincerely, 

Dr Helen Westwood