Government Guidance to GPs on Vaccine Safety Omits Pfizer Trial Data Showing Twice as Many Cardiovascular Deaths in Vaccinated

When Daily Sceptic reader Ian Price experienced an alarming adverse reaction to his first AstraZeneca jab he decided that he did not want to risk a second dose. However, his GP had other ideas and told him he should have Pfizer for his second dose. Despite being presented with worrying safety data from Pfizer’s own trial results, the GP would not agree to an exemption. Ian writes:

I am pro-vaccine but anti-mandate. However, I have recently discovered via correspondence from my GP that the Department of Health is not ‘following the science’ in the guidance it gives to GPs on vaccine safety.

By way of background, I declined the second vaccine following an adverse reaction to the first AstraZeneca vaccine received in March 2021. I remain partially vaccinated which means that I fall into the category of citizens described by Sir Tony Blair as “idiots”. Resenting the increasing stigmatisation of the unvaccinated, I discovered via Google search that there was such a thing as a vaccine exemption. After all, even Blair acknowledges that it is possible to have a “health reason” for not being jabbed. So I called the NHS number and had a form posted to me. I filled it in and dropped it off at my GP’s surgery.

“I’m struggling a bit with the Covid exemption form,” wrote my GP to me in a text on December 1st. “I am not sure I am comfortable with precluding you from the option of a second injection.” He was about to go away but offered a phone consultation on his return. Puzzled by his framing of the issue as being about not limiting my options, I agreed to the follow-up call.

In our long discussion on December 29th, his advice remained that I should take the Pfizer vaccine. I explained that I felt my risk from Covid was negligible and I was not convinced that it was greater than the risk from a second vaccine. He remained reluctant to issue an exemption but agreed to look into it further and come back to me. His subsequent text message read as follows: “I have re-read the guidance extensively on issuing of vaccine exemptions and unfortunately it can only be issued if there is a medical contraindication to receiving an alternate vaccine.”

He was good enough to attach a link to the guidance document from the Department of Health and Social Care. I looked at this document and found a further link to the Green Book Chapter 14a. As outlined in my letter to him below, the paragraph on the safety of the Pfizer vaccine reads as if the scientific evidence is reassuring. The paragraph cites two published papers that describe safety studies of the Pfizer vaccine: Walsh et al, 2020 and Polack et al, 2020. Both studies demonstrated very limited evidence of systemic events – “generally mild and shortlived”. Reading this paragraph, as a layman, I would conclude that there is no cause for concern.

Dated December 21st 2021, the Green Book omits Pfizer’s own trial data from the six-month stage – published on November 4th 2021 – even though it refers to an article published in the same journal in May 2020 by the same authors. While Pfizer has come in for criticism for its trial methodologies, the safety issues at the six-month stage are clear: out of 21,926 subjects in the vaccinated group, 6,617 or 30.2% experienced an adverse event. This compares with 13.9% in the placebo group. Related adverse events which an investigator has assessed as related to the Pfizer injection stood at 23.9% of the vaccinated group against 6.0% of the placebo group. The results also show an increased risk of death with nine from cardiovascular events compared with five from the placebo group. The evidence of risk is plain to see.

But this published paper – with the same authors and in the same journal (the New England Journal of Medicine) as the one of May 2020 – is not referred to in the Green Book. Is this a sin of commission or omission? It’s hard to say. My letter to my GP, attached in full as an appendix below, lays out my reasons for not getting a second vaccination. My GP called me on the phone and explained he still felt unable to award an exemption. When pressed he told me that he could not refute any of the arguments I made in my letter to him.

I respect my GP who I feel is, like his colleagues, under political pressure to vaccinate as many people as possible. I believe in personal autonomy when it comes to decisions such as whether or not to take a vaccine and it appears to me that by omitting the latest published evidence from Pfizer in its guidance to GPs, the Government is not being honest about vaccine safety.

Dear Dr. XXXXX

Happy New Year.

Many thanks for your text message of December 30th 2021 and for forwarding me the link to the Department of Health and Social Care clinical guidance document. Now that I’ve had a chance to take a look at the document, I wanted to come back to you.

Firstly, while I am disappointed in your decision not to issue me a vaccine exemption, I do accept that it is consistent with the guidance you shared with me. It is, I agree, unambiguous in stating: “A caution to one vaccine or vaccine type where safe alternatives are available should not lead to exemption.” On this basis, you have recommended to me that I take a Pfizer vaccine following an adverse reaction in April to AstraZeneca.

My issue is with the question of safety with regard to the Pfizer vaccine, particularly when, as I explained on the phone last week, set against the possible risks I face from COVID-19.

Risks from Covid

To get an objective sense of my risk from COVID-19, I used the QCovid risk assessment tool. Led by the University of Oxford, the development of this tool involved the Department of Health and Social Care and NHS England. Research published in the BMJ shows that the model performed well in predicting severe outcomes due to COVID-19 i.e., death and hospitalisation.

My absolute risk of catching and dying from COVID-19 – based on my age, BMI and all the other personal data entered – is 0.0018%.

Since the data used in the model is only as recent as June 2021, I assume that this risk is, if anything, now significantly lower since the milder Omicron variant is now prevalent. The risk figure does not, furthermore, account for the fact that I have had one vaccine.

Safety of Pfizer Vaccines as Presented in Department of Health & Social Care Guidance

The Guidance document links to the Green Book Chapter 14a for more information on vaccines and their cautions.
The Green Book has a paragraph citing two published papers that describe safety studies of the Pfizer vaccine: Walsh et al, 2020 and Polack et al, 2020. Both studies demonstrated very limited evidence of systemic events – “generally mild and shortlived”. Reading this paragraph, as a layman, I would conclude that there is no cause for concern.
However, my understanding of the Walsh et al, 2020 paper is that it covered data concerning the first seven days after vaccination only. The Polack et al paper, which I now understand to be derived Pfizer’s own trial data, has two months’ worth of study and efficacy data. The same authors published a six-month study dated November 4th 2021. The Green Book is dated December 21st 2021 and yet makes no mention of the follow-up study.
The Polack et al paper of 2021 reports adverse events among 30.2% of the vaccinated trial subjects as against 13.9% of the placebo group.

My evaluation of the risks confronting me

As I mentioned when we spoke on the phone, having experienced an adverse reaction to the first vaccine – something that caused me and my wife considerable distress – I have to trade off the risk of taking another vaccine against the combined risk of a) catching COVID-19 in the first place and b) falling ill as a result.
Pfizer’s own trial data published in the Pollack et al paper referenced in the Green Book shows an absolute risk reduction of 0.84% seven days after the second dose.
So, were I to take the vaccine as advised, I would be reducing my risk of dying by 0.84% – from 0.0018% to 0.0015%.
However, the risk of an adverse reaction to the vaccine at more than twice the rate experienced by the placebo group in Pfizer’s own trial strikes me as a considerably poorer option.

Summary

I am educated to Masters level in social science and can read an academic journal article. Nevertheless, I acknowledge that I am not a clinician and may have misinterpreted something. If so, please tell me what is the statistical likelihood of my serious injury, illness or death from the Pfizer vaccine? Also, please tell me what is the statistical likelihood of my serious injury, illness or death from COVID-19 if I were to remain only partially vaccinated?
On the principle of “first, do no harm” I urge you to reconsider your decision based on up-to-date clinical trial data that has not been included in Department of Health and Social Care Guidance.

Yours sincerely

Ian Price