F.O.I reveals the UK Medicine Regulator never inspected the Pfizer Covid-19 Vaccine trial data prior to its emergency use authorisation. [23/09/21]

As populations around the world face coercion to submit to COVID-19 gene-based ‘vaccination’, including being locked out of employment and medical care, while reports of deaths following vaccination soar, a scandal regarding the legitimacy of COVID vaccine authorisation processes is unfolding.

Following the exclusive revelation that a Freedom of Information request to the Australian drugs regulator (the Therapeutic Goods Administration or TGA) approved the Pfizer-BioNTech mRNA vaccine in record time, yet never sighted Pfizer’s patient-level data (IPD), another regulatory scandal is breaking.

By Doctors for Covid Ethics

Basic questions were asked of the TGA regarding their probity in performing their most fundamental task: validating clinical trial data submitted by Pfizer. Instead of verifying the data, the TGA simply rubber stamped the Pfizer vaccine, accepting on face value Pfizer’s misleading claim that their product showed “95% efficacy to prevent COVID-19 infection”.

Since then, worldwide data, particularly in the UK and Israel (but also in smaller countries such as Iceland and Gibraltar where vaccination rates approach 100% yet cases are still rising), have shown disappointing real world effectiveness, in contrast to Pfizer’s claims. Given Pfizer’s legal history of healthcare fraud it was imperative that the drug regulators verify the drug manufacturers’ submission data prior to COVID vaccine approval.

The TGA failed to do so, but what about the other drug regulator held in high regard around the world – the UK’s MHRA?

Doctors for Covid Ethics can reveal that the MHRA never validated Pfizer’s trial data either.

Freedom of Information Obfuscation

On 7^th June 2021, a Freedom of Information (FOI) request was submitted to the MHRA, seeking documentation relating to the temporary authorisation of the Pfizer (BNT162b2) and AstraZeneca (ChAdOx1) COVID-19 vaccines. Specifically, the FOI (FOI 21/632) sought:

1. Any documents requesting access from the sponsor [Pfizer and AstraZeneca] to the raw data (patient-level anonymised data or equivalent patient-level data).
2. Confirmation as to whether the MHRA holds the patient-level data (approximately 70,000 records) from these applications or whether these were restricted from access or assessment by the sponsor. If they were supplied, the format in which these records were supplied and how they were hosted at the MHRA (e.g. paper, or electronic database – specify format such as MySQL, MsSQL databases, csv, excel files).
3. Any documents confirming that a process for analysing the raw data from the sponsor was undertaken, and the result of that process (e.g. meeting minutes or equivalent) including the qualifications (and names if appropriate) of the committee (if any) which has undertaken the review of the raw data.

Rather than answering any of the questions or supplying documentation, however, the MHRA responded with generalities regarding usual process, and devolved their responsibilities to Public Health England, providing for a tangled web of deflection. See the MHRA’s initial response to the FOI request here, and the FOI applicant’s follow-up reply seeking specific answers rather than obfuscation here.

In addition to citing standard practice and noting that “the sponsor” ie Pfizer, “had access to the raw data”, the MHRA directed the FOI applicant to an earlier committee meeting with the Commission on Human Medicines (CHM), held on 24^th December 2020. Minutes from that meeting reveal that the CHM had been told: “Results from the MHRA analysis of raw data from the interim analysis showed VE of 91% (CI 63, 98) in the period from day 14 after the first dose to when dose 2 was given. Results from an independent analysis by Public Health England of the full Pfizer dataset were also discussed.”

A document summarising the CHM meeting is here.

However, based on their FOI responses, the MHRA appears not to have analyzed any raw data at all. In an email dated 29^th July 2021, following the FOI applicant’s second request for assurances that the MHRA had conducted its own data analysis, the MHRA stated:

“In order to clarify our previous statements, we can confirm the following for you: Patient-level data from clinical studies is submitted to MHRA with all applications to authorise new medicinal products. No authorisation was made to the sponsor, as none was required. “ The MHRA then directed the applicant to public posts regarding COVID vaccine authorization on government websites.

This reply was clearly inconsistent with the CHM minutes of 24^th December.

Read More – F.O.I reveals the UK Medicine Regulator never inspected the Pfizer Covid-19 Vaccine trial data prior to its emergency use authorisation. [23/09/21]