Part 1 of Paula Jardine’s investigation into how Pfizer secured its multi-billion-dollar US Covid ‘vaccine’ supply contract before their phase 3 clinical trials had even begun, suggest that an all-important advance promise of a UK MHRA Temporary Use Authorisation (TUA) was key to the timescale accepted. Today she asks which of the UK government’s advisers associated with the Vaccine Taskforce negotiating with Pfizer/BioNTech mooted or agreed to this prospect, and inquires into their possible conflict of interests. You can read Part 1 here.
PFIZER’S US Operation Warp Speed (OWS) contract of July 22, 2020, was executed under a special Defense Department mechanism called an Other Transaction Authority (OTA) which is ordinarily used to seamlessly transition prototypes ordered by DOD into production. This has the added attraction of beingawarded without need of oversight by other branches of government. OTA contracts are ripe for fraud. They have no standard accounting or auditing requirements, there are no dispute or change clauses and they can’t be terminated for default or convenience.
The phase 3 clinical trial of the Pfizer/BioNTech vaccine began on July 27, 2020, only after the OWS deal had been secured, and it began with a surprising development. The single vaccine candidate selected to go into this trial was not BNT162b1, a candidate designed by BioNTech itself which hitherto it was saying publicly was its most advanced candidate, but BNT162b2, a candidate designed by Anthony Fauci’s US National Institute of Allergy and Infectious Diseases (NIAID). This meant that NIAID received royalties for the design, providing it with a revenue stream that was not dependent on Congressional appropriations votes. That may be the principal reason for the switch. The fact that, as revealed in the European Trials register, one participant in cohort 12 of the BNT162b2 group died should have been an impediment but was simply ignored.
As explained in Part 1, the OWS contract was dependent on US Food and Drug Administration (FDA) authorisation, and it appears Pfizer had an understanding before the start of the phase 3 trial that there would be material assistance from the UK regulator to achieve this.
How exactly did this apparent collusion happen and which of the UK’s vaccine taskforce advisers were involved in misleading either or both Alok Sharma (now Sir Alok), then Secretary of State for Business, Energy and Industrial Strategy, or Matt Hancock, the Secretary of State for Health, about the propriety of it? Surely government ministers wouldn’t have put the health and safety of the British public at risk by sanctioning such a reckless scheme, would they? Which, bluntly, of the UK government’s advisers associated with the Vaccine Taskforce who were negotiating the UK’s supply contract with Pfizer/BioNTech mooted or agreed to the prospect of a temporary use authorisation and persuaded the ministers this was OK, when it patently was not? Which civil servants were party to this?
The answers to some of these questions are revealed in the May 17 2020 announcement by Alok Sharma of £84million new funding for Oxford University’s agreement with AstraZeneca announced that day. The government news release details an all-important Expert Advisory Board appointed to oversee the Vaccine Taskforce advising Sharma. It was chaired by Sir Patrick Vallance, then the Government’s Chief Scientific Adviser. It lists two key members of this boardas Sir Jeremy Farrar, a founder of Coalition for Epidemic Preparedness Innovations (CEPI) and then CEO of the Wellcome Foundation (now Chief Scientist of the World Health Organization) and Dr Richard Hatchett, chief executive officer of CEPI since its inception.
Other board members were the Oxford University trio Sir John Bell, Regius Professor of Medicine at Oxford University (who also oversaw the government’s investment in the deeply flawed Innova Lateral Flow Test), Professor (now Dame) Sarah Gilbert, responsible for co-developing theOxford–AstraZeneca vaccine, and Professor Sir Andrew Pollard, director of the Oxford vaccine Group. Pollard was also the chief investigator for the clinical trials of the Oxford-AstraZeneca vaccine and joint chair of the Government’s Joint Committee on Vaccination and Immunisation (JCVI) since 2013; at the time he was also a member of the WHO’s Strategic Advisory Group of Experts. Therefore his conflict of interests were multiple. His membership of the Taskforce Expert Board should have disqualified him from the JCVI, the committee that ‘independently’ advises the government on the deployment of vaccines and their age appropriateness. Another member of the board was a Vice President of AstraZeneca itself, Dr Menelas Pangelos. Together they recommended the UK government to direct large sums of public money, £88million all told, to fund the Oxford/AstraZeneca Covid vaccine.
The AstraZeneca announcement has all the appearance of being a closed shop and a done deal with Alok Sharma as the patsy. None of the ‘expert advisers’ seem to have been bothered at all about the appearance of impropriety given such overt conflicts of interest. It is interesting that the senior civil servants involved must have condoned this, raising the question of who was really in charge and who was calling the shots.
This Expert Advisory Board did not just oversee and advise for this particular AstraZeneca agreement.They advised the Vaccine Taskforce in general, and specifically over their negotiations with Pfizer/BioNTech.
With regard to this contract, two of the expert advisers had a clear conflict of interest with respect to BioNTech throughties to two of its major investors who profited handsomely as a result of the vaccine rollout, facilitated by the TUA collusion detailed in Part 1. They were Sir John Bell, by virtue of his membership of the Bill and Melinda Gates Foundations (BMGF) Scientific Advisory Board, and Sir Jeremy Farrar whose Sage Register of interests entry shows that he sat on the board of Temasek, Singapore’s national investment fund. BioNTech stock listing on the US NASDAQ index on September 19, 2019 revealed a BMGF $55million equity investment in the company. Temasek acquired a $250million equity stake in BioNTech on June 29, 2020, a few weeks in advance of the lucrative Operation Warp Speed contract.
Other notable members of the Expert Advisory Board were Kate Bingham, head of the Vaccine Taskforce and managing partner of the SV Healthcare Investment Company in which BMGF had previously invested $50million. Finally, the two individuals who were most directly involved in the issuance of the Pfizer/BioNTech TUA on the Board were Dr June Raine, chief executive of the MHRA, and Dr Jonathan Van-Tam, Deputy Chief Medical Officer at the Department of Health. He recently took a post at Pfizer’s rival Moderna.
Are we supposed to believe that in July 2020 they knew nothing of the proposal to use a TUA to launch the Pfizer/BioNTech mRNA vaccine and the deployment phase of the Covid vaccine plan? Is it credible that they did not see the huge money-making potential of the contracts they advised and the authorisations needed to secure them?
On August 28, 2020, scarcely a month into the phase 3 trial, Hancock’s Department of Health and Social Care initiated a public consultation on the use of the 2012 Human Medicines Regulation 174 mechanism under which a TUA could be issued. He said it needed to ensure the right legislative measures were in place, just in case ‘there is a compelling case, on public health grounds, for using a vaccine before it is given a product licence, given the nature of the threat we face’. He went on to warn that ‘the JCVI may take the very unusual step of advising the UK government to use a tested, unlicensed vaccine against Covid-19.’ To reassure the public, the weasel words were added: ‘A Covid-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine. “Unlicensed” does not mean “untested”.’
As we now know, there was a bait and switch and the product which was put into the trusting arms of the general public was not the same product tested in the phase 3 trial.This has been revealedthanks to the detective work of Dr Josh Guetzkow and his collaborators, who have shown that the vaccine batch EJ0553 authorised by Dr June Raine’s enabling agency the MHRA, just a fortnight after receiving a request for a TUA from Dr Jonathan Van-Tam, the Deputy Chief Medical Officer, on December 2, 2020, was an inferior quality mass-produced version of the mRNA vaccine used in the clinical trials, made with RNA fermented in e-coli and not by PCR amplification.
Contrary to the August assurance that ‘unlicensed’ does not mean ‘untested’, the product authorised by MHRA had not been tested on volunteers during the trial. A token 252 trial volunteersonly were dosed with a different batch of the mass-produced product. This data was not included in the final analysis of the phase 3 trial data which was submitted to MHRA for authorisation.
The MHRA December 2, 2020 TUA opened the door for the US HHS Secretary Alex Azar to direct the FDA to issue the Emergency Use Authorisation that enabled Pfizer to perform the OWS contract it entered into in July, albeit having missed its aspirational target of October 31, 2020. Under EUA guidance, the HHS secretary has only to make a determination that the medical countermeasure in question ‘might be effective’. As the US Government Accounting Office discovered, in December 2020 the Department of Defense negotiated additional contracts with Pfizer worth $4billion for 200million more doses of BNT162b2 vaccine (making a total of $6billion of the total $20billion Operation Warp Speed expenditure, or nearly a third) despite DOD officials saying ‘it had not yet fully demonstrated its prototyping efforts under the OTA – namely delivering 100million doses’.
The infamous batch EJ0553 which was authorised for temporary supply by the MHRA on December 2, 2020 was manufactured by Pfizer under its OWS contract which means that as per the HHS announcement of July 22, it was the property of the US military. It appears to have been agreed on some kind of lend-lease or donation arrangement which would explain why the July announcement of the UK/Pfizer supply agreement mentioned no sums of money.
We are left asking who brokered this transatlantic deal? There is one expert adviser with a foot in both camps and with a long-term vested interest in mRNA vaccine development: Dr Richard Hatchett, formerly Director for Biodefense Policy on the United States Homeland Security Council, and before he became CEO of CEPI 7 years ago, the Chief Medical Officer and Deputy Director of the US Biomedical Advanced Research and Development Authority (BARDA). Hatchett is also a long-time associate of Dr Robert Kadlec, the General Ripper of this ‘Dr Strangelove’ type Manhattan Project for Biodefense and the creator of Operation Warp Speed. This puts Hatchett squarely in the frame.
And who thought it appropriate to appoint a man with such powerful vested foreign interests as a key UK science adviser to such significant and for the British population, risky contracts? Sir Patrick Vallance? Was it Hatchett who pushed for and engineered a deal that would realise his particular ambitions? And what does that make his fellow UK Government expert advisers – accomplices or useful idiots? Finally, were either Mr Hancock or Mr Sharma aware of this scheme to help Pfizer? Or was this Expert Board a law unto itself?