I told you here about Pfizer’s abstract of its Interim Report 5, showing at least 23-40% higher risk of some heart-related conditions in the vaccinated, but that the MHRA, the U.K. medicines regulator, was withholding publication of the full report. As I said at the time : “In summary, if, as I suspect, MHRA is worried by the results in Pfizer’s ‘Interim Report 5’ then no wonder it is sitting on it.”
Well, MHRA is still sitting on the report but I’ve managed to obtain a copy. It looks like I was right – the detailed results in the full report are even more worrying than the Hazard Ratios in the abstract which I reported last time (below).
To recap: this is a report of a Post Authorisation Safety Study (PASS) of Pfizer’s Covid vaccine. National regulators routinely require pharmaceutical manufacturers to conduct PASS studies as a condition of authorisation of most new medicines. The regulators provide data to the manufacturer covering millions of patients registered in national healthcare systems. The manufacturer then conducts analysis, matched for things like age and sex, to determine whether the medicine has increased the risk of specified health conditions.
Let’s dive straight in. Below are some heart-related cumulative incidence graphs from Pfizer’s full ‘Interim Report 5’. You will immediately notice that the incidence for each type of condition is significantly greater in the Covid vaccinated (bad) – but we already knew that from the Hazard Ratios in the abstract. What’s worse is that the curves diverge over time, i.e., the relative incidence between vaccinated and unvaccinated increases over the time period of the data in the report (December 8th 2020 – March 21st 2022). I wonder what happened subsequently.
Acute cardiovascular injury (23% higher in the vaccinated and getting worse; page 130):
Arrhythmia (27% higher in the vaccinated and getting worse; page 138):
Heart failure (2% higher in the vaccinated and getting worse, though not quite statistically significant at this point; page 146):
Stress cardiomyopathy (30% higher in the vaccinated and getting worse, though not yet statistically significant; page 153):
Coronary artery disease (40% higher in the vaccinated and getting worse; page 160):
Myocarditis (21 days) (130% higher in the vaccinated, though not quite statistically significant; page 168):
No wonder MHRA is still sitting on the report. Perhaps it is hoping that Pfizer can spirit away these horrendous results from its Final Report (apparently still in preparation).
These results don’t just affect Covid vaccinated individuals. They also have wider safety implications for, say, aviation where the third party consequences of sudden pilot incapacitation from a heart condition can be catastrophic for passengers and those on the ground – especially for single pilot operations.
As I said in my last article, I wrote to the Civil Aviation Authority (CAA) about this in October, sending it a copy of Pfizer’s abstract of its report. CAA’s reply was a tragic comedy. It thought that Pfizer’s report was describing 37 events in 12 million people so it was completely dismissive. Apparently, at that rate, “if all U.K.-licensed commercial pilots received the vaccine, we would expect fewer than one to have experienced significant adverse effects”.
Sadly for the CAA, Pfizer’s report is actually describing 37 different types of events (and thousands of them) and the relative incidence for each type of event between 12 million vaccinated people and 12 million unvaccinated people matched for things like age and sex. I replied pointing out that:
- Pfizer’s abstract of its Interim Report 5 (March 2024) shows a higher incidence of heart problems in the Covid vaccinated population.
- CAA’s aeromedical regime for pilot licensing is based on the rate of sudden incapacitation in the general population.
- CAA’s aeromedical regime was never 100% effective – there was always residual risk of a pilot passing the medical with a subclinical heart problem which later manifests during flight. It calls this residual risk the “1% rule”.
- Pfizer’s report means that the rate of sudden incapacitation in the general population has increased, so proportionately more pilots will pass medicals with subclinical heart problems which, in turn, increases the risk of sudden pilot incapacitation in flight.
- It is axiomatic that CAA needs to adjust the periodicity and depth of its aeromedicals.
I await CAA’s further reply.
There is one other thing which has happened in the background: Esther McVey MP has asked a couple of Parliamentary Questions about Pfizer’s report of increased heart problems in the Covid vaccinated:
- The first asked if MHRA had consulted other industry safety regulators about Pfizer’s report. The answer was no. It seems to me that there is clash of safety cultures: MHRA think safety is relative (“safe equals benefits greater than risk”) so it probably didn’t even occur to its officials to consult other industry safety regulators who actually deal in absolute risks.
- The second question asked the Department for Transport what implications Pfizer’s report had for CAA’s aeromedical regime. DfT denied that it had any implications at all. It seems to me that DfT/CAA is ignoring the obvious.
So where are we now. We’ve got MHRA not consulting other industry safety regulators about the obvious wider safety implications of Pfizer’s report of increased heart problems in the Covid vaccinated, and CAA unable to read Pfizer’s report properly or being in denial.
This is, quite literally, deadly serious. The truth will out.
Until Nick retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. medicines regulator the MHRA.
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