- The MHRA watchdog says no corners were cut to authorise Covid-19 vaccines – but permitted the use of a lower quality mass-produced version of the Pfizer/BioNTech vaccine on the general public
- The public were told the vaccine had been tested on tens of thousands of people but only 500 doses of this version were tested on volunteers
- The UK government, Matt Hancock and the MHRA helped in the gaming of the approval process to launch the Manhattan Project for Biodefense
ON MAY 16 this year Israeli academic Josh Guetzkow tweeted ‘Was the Pfizer/BioNTech vaccine clinical trial a bait-and-switch?’
Guetzkow had discovered from an amendment made on October 20 2020 to Pfizer/BioNTech’s clinical trial protocol that only a tiny number of the 44,000 participants in the Pfizer/BioNTech Covid-19 clinical trials were given doses that came from batches manufactured using the scaled-up processes used for the commercially supplied product. According to Guetzkow and another Israeli academic, Retsef Levi, two lots taken from two mass-manufactured batches were each given to 250 token participants, while the other participants were given doses from clinical supply batches.
Effectively, Pfizer was like the Coca Cola Company in the 1980s: Pfizer tested original Coke on the vast majority of its trial volunteers while making plans to substitute a minimally trialed New Coke when it rolled out its genetic vaccine to the wider public.
A letter by Guetzkow and Levi published in the BMJ on May 13 2023 identifies the Process 2 mass manufacture product used during the trials as coming from batches EE8496Z and EJ0553Z.
Batch EJ0553 is the same batch of Pfizer/BioNTech’s mRNA Covid-19 injectable that the UK began using on the general public in December 2020 under a temporary supply authorisation.
‘This is unprecedented prior to the SARS-CoV-2 injections,’ said Hedley Rees, a consultant specialising in life sciences operations and supply chain management. ‘Marketing Authorisation Holders (full) must comply with Good Manufacturing and Distribution Practice (GMDP), so by inference, it applies to the conditional authorisations. Under these circumstances, any change to the process or input materials renders the product different to the previous product and a full battery of safety testing in animal models must be carried out.’
On November 10, 2020, the day after preliminary results provided by Pfizer/BioNTech claimed their mRNA vaccine was 90 per cent effective, Secretary of State for Health and Social Care Matt Hancock made a statement in the House of Commons.
‘The full safety data are not yet available, and our strong and independent regulator the Medicines and Healthcare products Regulatory Agency will not approve a vaccine until it is clinically safe,’ said Hancock. He told the House that he had tasked the NHS with being ready to deploy the vaccine at any date after December 1.
According to the MHRA Public Assessment Report, Hancock’s Department of Health and Social Care (DHSC) wrote to it on November 17, 2020, requesting it to issue a temporary use authorisation under Regulation 174 of the UK Human Medicines Regulations. The request was made about two weeks before BioNTech Manufacturing GmbH submitted an application to the European Medicines Agency (EMA) for a conditional marketing authorisation on November 30, 2020.
While the UK was still under European Union law, the product should have been authorised by the EMA under its centralised procedure. The MHRA circumvented the agency using the temporary supply provision to authorise batch EJ0553.
The temporary supply was signed off by the Life Sciences minister Lord Bethell on December 1, 2020 but the news was embargoed until 7am the following day when Hancock appeared on Sky News to make the announcement before the stock market opened.
‘Fantastic news!’ said Hancock. ‘The MHRA, the fiercely independent regulator, has clinically authorised the vaccine for rollout. The NHS stands ready to make that happen. So from early next week, we will start the programme of vaccinating people against Covid-19 here in this country. As we know from earlier announcements this vaccine is effective. The MHRA have approved it as clinically safe and we have a vaccine so it’s very good news.’
Hours after his appearance on Sky, Hancock made a statement to the House of Commons: ‘We were the first country in the world to pre-order supplies of this successful vaccine and we have 40million doses pre-ordered for delivery over the coming months, enough for 20million people, because two jabs are required each.
‘Following authorisation, the next stage is to test each batch of the vaccine for safety. I can confirm that batch testing has been completed this morning for the first deployment of 800,000 doses of the vaccine. These doses are for the whole UK.’
The day of the announcement, MHRA put out an informational video to reassure the public. ‘Safety is our watchword, and we are globally recognised for requiring the highest standards of safety, quality and effectiveness for any vaccine,’ said the chief executive Dr June Raine. She also gave a press briefing alongside Professor Sir Munir Pirmohamed of Liverpool University, the chair of the Commission on Human Medicine’s Expert Working Group on Covid-19 vaccines, and Professor of Respiratory Medicine Wei Shen Lim of Nottingham University, the chair of the Joint Committee on Vaccination and Immunisation. Pfizer is an industry partner of the University of Nottingham funding respiratory disease research, while Liverpool University, under pressure from the Bill and Melinda Gates Foundation-funded UNITAID, played down ivermectin as a cheap and effective treatment for Covid-19.
Pirmohamed told reporters: ‘It’s important to note that what we have got is data relating to the vaccine up to this point. It’s important that we undertake surveillance following the use of vaccines in the population and we were very keen to recommend that the MHRA undertakes active surveillance of the vaccine after it is used and this includes the use of Yellow Cards, as well as a special active monitoring programme which we will be inviting people to join.’
The Yellow Card system, like the US Centers for Disease Control’s Vaccine Adverse Events Reporting System (VAERS) is a passive surveillance system that relies on voluntary reports. There is no evidence that the MHRA did implement an active (mandatory) reporting system to evaluate comprehensively the safety of this product in a real-world experiment.
The day after 90-year-old Margaret Keenan became the first person in the UK to receive a dose of the mRNA Covid-19 vaccine on December 8, 2020, Raine appeared before the House of Commons Health and Social Care Committee. She said: ‘As the Covid-19 pandemic is a public health emergency, we undertook to complete our scientific evaluation and approval in the shortest possible time, while complying with established and robust safety, quality and effectiveness standards . . . the highest standards of safety, effectiveness and quality have been met. No corners whatsoever have been cut. There are no compromises on standards whatever.’
However, the analysis by Guetzkow and Levi raises the startling possibility that batch EJ0553 had not even been delivered to the four Pfizer clinical trial sites in the US before the DHSC made the temporary supply request to the MHRA. The Israelis state in their BMJ letter: ‘Two documents obtained through a Freedom of Information Act (FOIA) request describe the vaccine batches and lots supplied to each of the trial sites through November 19, 2020 and March 17, 2021, respectively. According to these documents, doses from “Process 2” batch EE8493Z are listed at four trial sites prior to November 19, and four other sites are listed with “Process 2” batch EJ0553Z in the updated document.’
Batch EJ0553 was manufactured by Pfizer in Andover, Massachusetts, on September 25, 2020, as Pfizer endeavoured to meet its contractual commitment to demonstrate to the US Department of Defense its ability to manufacture 100million doses by October 31, 2020. The Operation Warp Speed contract anticipated FDA approval by the same date.
On 10 March 2021, having been sent leaked EMA documents, the BMJ reported that the EMA was concerned that the ‘commercial manufacturing was not producing vaccines to the specifications expected’.
A Pfizer/BioNTech slide deck for a meeting with the EMA on November 26, 2020, which appears to have come from the EMA leak, outlines the companies’ reply strategy to objections raised by the EMA including that GMP (Good Manufacturing Practice) status for the Andover site where Batch EJ0553 was manufactured was not ‘acceptably demonstrated’ nor had the comparability between the clinical and commercial product been demonstrated. EMA inspections of the Andover facility were ongoing.
Days later the MHRA told the British public in its December 2020 Public Assessment Report that it ‘has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for this product at all sites responsible for the manufacture, assembly and batch release of this product’.
It was further satisfied by the manufacturer that, at least so far as the data for the authorised batch went, ‘the manufacturer has performed a comparability assessment of drug substance batches used in the clinical trial programme and batches representative of the subsequent manufacturing changes occurring during product development, such as introduction of new manufacturing sites, manufacturing process changes and increase in batch scale, including full scale validation batches’.
Guetzkow and Levi point out that Pfizer undertook to do comparative immunogenicity and safety analyses comparing 250 randomly selected ‘Process 1’ batch recipients with the ‘Process 2’ batch recipients. ‘To the best of our knowledge, there is no publicly available report on this comparison,’ they said, while noting that 491 reports (138 serious, 21 deaths) for lot EJ0553 had been reported to the US Vaccine Adverse Events Reporting System (VAERS).
The deaths associated with Batch EJ0553 reported to VAERS include causes that have become prevalent in the aftermath of the vaccine rollout – cardiac arrest, stroke and sudden death. Some deaths included ‘drug ineffective’ reports. Judging by the reported vaccination dates and the large number of ‘foreign’ locations reported, many of the VAERS reports for this batch concern British recipients. Perhaps Matt Hancock is profoundly sorry for the deaths and permanent disabilities memorialised in these VAERS reports too?
As Pfizer’s junior partner BioNTech acknowledged to investors, under US Food and Drug Administration (FDA) rules, mRNA is classed as a gene therapy. BioNTech registered the trial of its Covid vaccine BNT-162b2 with the EMA, enabling Pfizer to take advantage of a regulatory back door identified in 2017 to evade the more onerous advanced medicines trials protocols gene therapies are also customarily subject to in Europe.
After the MHRA issued the TUA, the FDA cut short its review process and issued Pfizer an Emergency Use Authorisation (EUA) on December 11, 2020, as US Health and Human Services Secretary Alex Azar’s PREP Act declaration of February 4, 2020, gave it authority ‘to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives’. A PREP Act provision also enables the fast-tracking of vaccines authorised by regulators it considers to have equivalent competency to the FDA, the MHRA in this case.
Ten days after the FDA issued its EUA, the European regulator fell into line, issuing its equivalent of an EUA which is called a Conditional Marketing Authorisation (CMA). As the UK was still under EU law, this CMA superseded the MHRA’s TUA and the UK rollout proceeded without the need inherent in the TUA process for batch-by-batch approval.
Now, Mr Hancock, would be a good time for some brutal honesty about who you were taking advice from before the UK Government and the ‘fiercely independent’ MHRA enabled the gaming of the international regulatory approvals process to roll out this Manhattan Project for Biodefense, while being complicit in this bait and switch.