Concerning Safety Signals Revealed by Hidden Pfizer Vaccine Report

I want to pick up a few threads from the debate on excess deaths on January 16th secured by Andrew Bridgen MP (transcript and video).

The debate was about the fact that significantly more people than expected have been dying for over two years now, particularly in younger age groups. This is not in dispute – it was acknowledged by both the Health Minister and her Labour Shadow as a concern which needed to be investigated. Well, get on with it then!

The threads I want to pick up are, first, the data required to investigate the issue and, second, the recent study published in the Lancet which one Labour MP trotted out during the debate in support of the Covid vaccines to try to rubbish what Andrew Bridgen had said.

First, the data. Andrew Bridgen mentioned that any investigation would require record-level data on Covid vaccine dosage, dates and deaths. He noted that the HART Group had requested those data from the Government over a year ago. Both UKHSA and MHRA have confirmed that the data exist but are, currently, avoiding releasing them. A complaint to the Information Commissioner is pending. Andrew Bridgen pointed out the irony that the MHRA has already released the data to Pfizer, AstraZeneca and Moderna. I can shed more light on that from my own research and FOI requests.

MHRA approved the release of the data to Pfizer, Moderna and AstraZeneca over two years ago for use in their Post-Authorisation Safety Studies (PASS). Basically, the PASS studies – which I first wrote about here – are using using national health records on millions of people in Italy, Netherlands, Norway, Spain and U.K. to investigate whether there is an increased risk of Adverse Events of Special Interest (AESI; including death) associated with the Covid vaccines.

I recently managed to obtain the companies’ PASS interim reports via an FOI request. U.K. data for 2020 and 2021 were included in the companies’ first interim reports but not for 2022 and 2023. Those data were unavailable for subsequent PASS interim reports due to, firstly, “CPRD server capacity issues” (page 72 of Pfizer’s second report dated September 2022) and then “a quality issue with the CPRD data availability” (page 74 of its third report) which wasn’t resolved in time for its fourth (dated September 2023). Negligence, incompetence, sinister? Make of it what you will.

Anyway, despite the limited U.K. data, what do the latest PASS reports say? Well, they are very long – thousands of pages and hundreds of tables so they take a lot of digesting. But in summary, there are conflicting results between national datasets for the same AESI, and there are some AESIs where incidence rates are higher in the vaccinated than the unvaccinated and vice versa. So it’s quite hard to see the wood for the trees. But, taking the Pfizer fourth interim report (dated September 2023 but which used U.K. data for 2020-21 only), if one jumps to the ‘discussion’ there are some worrying words (from page 159):

Arrhythmia: “Rates were comparable between vaccinated and non-vaccinated. In the tails of the survival curves (after 100 days), the curves flattened in most data sources except in CPRD [Clinical Practice Research Datalink, a depository of data from primary care doctors] where the risk increased.”
Heart failure: “The incidence of heart failure was uncommon any time after the start of follow-up and increased with age, as expected, in all data sources. Rates were comparable between vaccinated and non-vaccinated individuals. In the tails of the survival curves (after 100 days), the curves flattened in most data sources except in CPRD where the risk increased.”
Acute coronary artery disease: “From day 100-150 onwards the incidence was much lower, and the curves flattened in all databases except in CPRD where there was an increase in the cumulative incidence, especially in the vaccinated cohort.”

I readily acknowledge that for some other AESIs, the incidence rate is higher in the unvaccinated cohort which, in isolation, may support Covid vaccination (absent a healthy vaccinee bias). But that’s the ‘benefit’ side of the equation. The ‘safety’ side of the equation is that, for those AESIs I have picked out, there is a higher incident rate in the vaccinated cohort. To me, that’s a loud safety signal which would surely have rung alarm bells in MHRA. You would therefore think that MHRA would therefore have strained every sinew to make sure U.K. data for 2022 and 2023 were available as soon as possible, certainly for the companies’ final PASS reports due later this year. Perhaps an MP would like to ask the Health Secretary to provide a proper explanation of the data availability issues and confirmation that they have been resolved.

The other thread I want to pick up from the debate is when Sir George Howarth quoted a study just published in the Lancet. He said that the report concluded that “Missed vaccines ‘caused 7,000 Covid hospitalisations and deaths’” which “makes completely the opposite point to his (Bridgen)”. Unfortunately for Sir George, he seems not to have read the report because its conclusion relates to the under-vaccinated not the unvaccinated. The report actually says “Our estimates for the 16-74 years and 75 years and older age groups show that being unvaccinated was associated with similar or lower hazard ratio for severe COVID-19 outcomes compared with being vaccinated but having a vaccine deficit of at least one dose.”

The study offered a couple of explanations for that inconvenient truth: vaccine waning and healthier individuals being more likely to be unvaccinated. There are two very serious problems with that:

Conventional wisdom is that unvaccinated individuals are, on average, unhealthier than those who get vaccinated. However, the Lancet’s peer-reviewers obviously didn’t bat an eyelid at a study which tries to explain an inconvenient truth by claiming the complete opposite.
The Lancet’s peer-reviewers didn’t think to ask whether another explanation might be immune degradation resulting from the Covid vaccines. I think that’s an obvious question and I’m just an Engineer and Safety Manager.

My takeaways from the excess death debate were therefore:

The Government needs urgently to get on with the investigation into excess deaths which it readily agrees is required. Deferral of the Covid Inquiry Module 4 (Vaccines and Therapeutics) – which Andrew Bridgen mentioned in his speech – indicates the opposite.
There is something seriously wrong when the Government releases our health data to Big Pharma but won’t release thrm to us.
MPs who quote studies should actually read them, not rely on the mainstream media headlines.
The Lancet, once one of the most respected medical journals, should hang its head in shame.

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.