For six months, the MHRA and other national regulators have been sitting on a Pfizer report about Covid vaccine safety. Worryingly, the abstract which I have just found online doesn’t look good at all:
- the vaccinated cohort have at least 23-40% higher risk of some heart-related conditions; and
- the risk is higher than in Pfizer’s previous report (i.e., it is increasing over time since vaccination).
The report in question is Pfizer’s report C4591021 ‘Interim Report 5’ dated March 12th 2024. It is a Post Authorisation Safety Study (PASS) of Pfizer’s Covid vaccine. In summary, 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 to determine whether the medicine has increased the risk of specified health conditions.
I have previously written a couple of articles about Covid vaccine PASS studies. First, in October 2023, to raise awareness of the studies and the fact that most of them were not being published. Second, in January 2024, to report that I had obtained copies of PASS studies by Pfizer, Moderna and AstraZeneca via a Freedom of Information request to the MHRA. In the second article I picked out three health conditions (arrhythmia, heart failure and acute coronary artery disease) from Pfizer’s ‘Interim Report 4’ where there was a higher incident rate in the vaccinated cohort.
Knowing that Pfizer had completed its ‘Interim Report 5’ in March 2024, in April I submitted FOI 24/075 to MHRA asking for a copy. MHRA applied a Section 22 Exemption: “information intended for future publication.” This seemed very odd given that it had sent me previous ones only three months before. However, helpfully, it stated that it “will be published in the fourth quarter of 2024”.
So in late August, I submitted another FOI (24/475) to check that this was still MHRA’s intention. Imagine my surprise when it backtracked: “We cannot confirm whether the Pfizer C4591021 Interim Study Report 5 prior to December 31st 2024 is still due to be published. We have contacted the company, who have informed us that the final report is due for submission at the end of 2024 and plans for publication will be decided at this point.” I read that as: “We’re worried about the results in Interim Report 5, so we’ve decided to wait for Pfizer’s Final Report before deciding if and when to publish either of them.”
Imagine my further surprise when I just found an abstract of Pfizer’s ‘Interim Report 5’ online. As I said at the start, it doesn’t look good. Here are the first six conditions mentioned in the abstract:
Now, a Hazard Ratio of 1.23 means that the condition is 23% more likely in the vaccinated cohort, and “CI” mean confidence interval, i.e., we can be 95% confident that the ‘true’ number lies between the following two numbers. So those data are extremely worrying. This is the manufacturer bearing out the numerous anecdotal reports of increasing heart issues since 2020 as well as various independent research reports.
Worse, those data are worse than the corresponding figures in Pfizer’s previous ‘Interim Report 4’. In other words, the risk appears to be increasing over time since Covid vaccination.
And by the way, none of the above can be attributed to Covid itself: the exposure to Covid will be broadly the same in both the vaccinated and unvaccinated cohorts, which comprise millions of individual patients.
That said, there are potential confounders. The abstract suggests two:
- that for any condition, the seriousness might vary within and between the cohorts; and
- ‘healthy vaccinee’ bias – the argument that vaccinated individuals are more likely to seek medical attention.
But that’s one reason why we need to see the whole Pfizer report – to see the whole dataset, results and argumentation which lead to Pfizer’s explanation about confounding.
Even more importantly, we need to see the whole report because the Hazard Ratio will vary by age: younger people are normally much less prone to heart-related conditions than older people. Imagine how surprised I will be if the Hazard Ratios in the full report for younger age groups are even worse than those in the abstract (which are averages across all age groups). Is MHRA sitting on information which actually confirms the many siren warnings that it was reckless for MHRA to authorise, and JCVI to recommend, Covid vaccination of younger people who were at extremely low risk from Covid when it was known at the time that the Covid vaccines didn’t stop transmission and there were no long term safety data?
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.
One final thought. The Covid Inquiry Module 4 (Vaccine & Therapeutics) oral hearings are scheduled for January 14th-25th 2025. It would be a travesty if Pfizer’s ‘Interim Report 5’ and ‘Final Report’ were withheld from the inquiry. Perhaps one of the core participants or their legal representatives will request copies or question MHRA about the data at the oral hearings.
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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The problem with human nature when it comes to the “vaccine” farago is that unless it kills or debilitates you you within say a few months then anything else you suffer from in future cannot possibly be due to the jab, well, because of the passage of time.
Tick tock I’m afraid though especially re the mmRNA jabs.
I heard today that bigpharma’s Holy Grail is to ensure all kids are on statins from an early age – in order to lessen the burden on the NHS.
And heaven gently weeps.
As time passes, there’s plenty more to blame rather than one item. And as was discussed the other day, GP outfits like the one I use are offering more than one at the same time, i.e. covid-19 and ‘flu jabs at the same time.
I’ve had 4 invites and counting from my GPs, I will not be taking them up on the offer ever, I have not had a flu jab for 5 years or more.
73, Never had one.
Anyone that messes with the mevalonate pathway is damaging the basic function of digestion and nutrition. Statins show extremely low absolute risk reduction numbers, in the order of 1% at best. They are snake oil in tablet form.
As time passes and vacinees have other medical interventions and “life events” it will be easier and easier for the authorities to dispute and/or disguise the real cause of their health issues.
The longer they can delay publication, the greater their opportunity to obfuscate and deny causation for those tempted to make a claim to the Vaccine Injury Compensation scheme.
What a brilliant find!
The FOI that launched a 1,000 class action law suits.
How do we get the ball rolling? I’m in.
So maybe after a 3yr lag Pfizer will have to agree with what ICAN and the independent media have been saying all along
This para is a bit of a confessional bombshell too
“To assess baseline exchangeability of the comparator cohorts, the incidences of COVID-19 in the first 12 days after vaccination in the vaccinated and unvaccinated cohorts were
compared. These incidences were similar, demonstrating that matching had achieved
comparable cohorts”
So does this mean in English, ‘our vaccine does sod all?’ If I am understanding the wording?
What is risk of myocarditis within 21 days in relation to a report on long-term risk? Does this relate to persons who started getting jabbed in 2021 and are continuing to take the jab?
A 130% is particularly alarming.
If the vaccine roll out was done with the best of intentions the regulatory authorities would have carefully monitored those receiving it for any adverse events. They then would have designed and carried out randomised control trials to test for any conditions they were seeing signals for. This is not rocket science, its basic science.
Unblinding the trials very early on was a sign all was not well in my opinion… it’s basic science 101 stuff
They always unblind trials.
It’s in their DNA, or is it RNA or maybe modified messenger RNA
Has BBC Verify checked this study yet…?
Excellent work by the author. Persistence and tenacity in getting this information to reveal the truth is commendable.
I long for the day when the despicable MHRA is finally prosecuted for gross misconduct, negligence and incompetence and deliberately withholding essential, life saving information from the public. They should be some of the first to swing at Nuremberg 2.
Well done to “Nick” for his persistence. The truth will – eventually – come out just as it has for other scandals, but sadly I think it will be a very, very long time before there is any admission of “mistakes” by the Blob and Ministers who perpetrated the crime.
Watching the end of GB News last night where they mention who is the hero of the day. Steven Woolfe mentioned Dominic Cummings as a hero regarding the vaccine procurement in a discussion about coming out of the EU. Steven is usually quite based, and it is regrettable listening to people who should know better, at this stage, who use the “Rollout” as some sort of WW2 moment.
Drag it out long enough and we might all forget, or be distracted by nuclear war with Russia, frequent Net Zero blackouts, the next “Novel” virus.