This is the third part 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. You can read Part 1 here and Part 2 here.
IN EVERY Faustian bargain there is a price to be paid. It is now apparent that in July 2020 there was an understanding between Pfizer and the UK Vaccine Taskforce that Pfizer could expect material assistance from the UK and its ‘regulator’ MHRA in the form of a temporary use authorisation (TUA) for the BioNTech mRNA covid vaccine, BNT162b2. The UK had no financial stake in this ‘vaccine’, so what did it receive in return for its assistance with this audacious authorisation that unlocked Pfizer’s $5.95billion contract with the US Department of Defense (which I reported here). Surely it was not an act of charity? The answer appears to lie at No 1 Francis Crick Drive in Cambridge, the headquarters of AstraZeneca, and in the Operation Warp Speed deals it was negotiating with the US government in May 2020.
On April 30, 2020, AstraZeneca and Oxford University announced they had entered into a global licensing agreement for a Covid vaccine developed by Oxford University’s Jenner Institute which had gone into phase 1 trials the week before. Pascal Soriot, AstraZeneca’s chief executive officer, said: ‘As Covid-19 continues its grip on the world, the need for a vaccine to defeat the virus is urgent. This collaboration brings together the University of Oxford’s world-class expertise in vaccinology and AstraZeneca’s global development, manufacturing and distribution capabilities. Our hope is that, by joining forces, we can accelerate the globalisation of a vaccine to combat the virus and protect people from the deadliest pandemic in a generation.’
It just so happened that the Oxford Jenner Institute team led by Professor Sarah Gilbert (now Dame Sarah) had a head start. When SARS-CoV-2 emerged in January 2020, they had been developing a MERS-Coronavirus vaccine since 2016 and were able to pivot from one to another as it uses the same vector, a genetically modified chimpanzee common cold virus called an adenovirus. This was the one used in the first gene therapy trial in 1999 during which 18-year-old volunteer Jesse Gelsinger died. As MERS-Coronavirus vaccines have a limited commercial market with only a few thousand people ever having been sick with MERS, the Jenner team were co-developing a so-called ‘One Health’ vaccine for use in both humans and susceptible animal species. Having first been tested in Saudi Arabia on camels, the Jenner Institute’s MERS vaccine went into a phase 1 trial in 2018 thanks to funding from Jeremy Hunt’s Department of Health and Social Care, UK National Institute for Health Research and an $18million award from the Coalition for Epidemic Preparedness Innovations, CEPI.
The Oxford-AstraZeneca partnership was to be the basis of a new long-term venture according to Professor Sir John Bell, Regius Professor of Medicine at Oxford University: ‘Our partnership with AstraZeneca will be a major force in the struggle against pandemics for many years to come. We believe that together we will be in a strong position to start immunising against coronavirus once we have an effective approved vaccine. Sadly, the risk of new pandemics will always be with us and the new research centre will enhance the world’s preparedness and our speed of reaction the next time we face such a challenge.’
On 17 April 2020, just two weeks before the AstraZeneca/Oxford partnership was revealed, Business Secretary Alok Sharma and Health Secretary Matt Hancock announced the launch of a vaccine taskforce to ‘support and accelerate the development of a vaccine for coronavirus’. Representatives from government, academia and industry, they said, were ‘coming together’ to form the taskforce. They would include ‘government Life Sciences Champion Sir John Bell, as well as AstraZeneca and the Wellcome Trust.’ Other expert advisers to the Vaccine Taskforce included Bell’s Oxford colleagues Sarah Gilbert and Andrew Pollard, not to mention AstraZeneca’s executive vice President, Menelas Pangalos. Funding decisions were taken by a ministerial committee made up of Hancock and Sharma, Steve Barclay, the Chief Secretary to the Treasury, and Lord Agnew of Oulton, the Minister for Government Efficiency.
In July 2020, the Treasury allocated £5.2billion in funding to the Vaccine Taskforce to help it achieve its objectives which included investing in vaccine development and manufacturing as part of a long-term industrial strategy focused around pandemic preparedness. Of this, £2.9billion went to companies developing vaccines including Oxford/AstraZeneca, Valneva, GlaxoSmithKlein and advance purchase agreements were made with Pfizer/BioNTech and Moderna for mRNA vaccines. A total of £405million was awarded to private companies to expand their manufacturing capacity. Recipients included Oxford BioMedica, an Oxford University spin-off cell and gene therapy company which was sub-contracted to manufacture the Oxford-AstraZeneca covid vaccine. The taskforce facilitated a collaboration between Oxford Biomedica and the Vaccine Manufacturing and Innovation Centre (VMIC) in Harwell, Oxfordshire. The VMIC was set up by Oxford University, Imperial College London and the London School of Tropical Medicine and Hygiene in 2018 with £66million in UK government funding to focus on pandemic preparedness. A company called Cell and Gene Therapy Catapult, whose chairman Ian McCubbin was also a Vaccine Taskforce expert adviser, was awarded £16million to finance its acquisition of a veterinary pharmaceutical factory from Benchmark Holdings.
One of the earliest awards, announced on May 17, 2020 by the Vaccine Taskforce, was £84million in funding for the development of the Oxford-AstraZeneca covid vaccine. Kate Bingham (now Dame Kate) was appointed as chair of the taskforce the day before, precluding, it would appear, any involvement by her in this decision.
AstraZeneca CEO Pascal Soriot, welcoming the funding, said: ‘AstraZeneca is at the forefront of the response to Covid-19, and we are proud to be working with Oxford University to help make this vaccine available as quickly as possible. I would like to thank HM Government for its commitment to the vaccine and welcome its leadership and generosity for its help in expanding access beyond the UK. Our company is working hard to establish parallel supply agreements with other nations and multilateral organisations to ensure fair and equitable access around the world.’
In fact, the UK government’s £84million was far from sufficiently generous given that the stated ambition was to have up to 30million doses (out of a total of 100million doses) available by September for people in the UK. The timeline proved unachievable when the phase 3 trial was paused that month after a trial participant developed a serious inflammation of the spinal cord, transverse myelitis, which can cause permanent paralysis. AstraZeneca said: ‘In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully.’
The UK government’s £84million was not the only funding secured by AstraZeneca in May 2020. Further funding came from across the Atlantic where, on May 15, 2020, President Trump announced the US government’s Operation Warp Speed programme which he compared to the World War 2 Manhattan Project to develop a nuclear bomb. ’That means big and it means fast,’ Trump said. ‘We have the military totally involved.’
Just five days after President Trump’s announcement, AstraZeneca’s American subsidiary secured $413.2million from the very same US Operation Warp Speed programme for advance funding for the clinical development and manufacturing of the Oxford ChAdOxInCoV-19 vaccine. This agreement was between AstraZeneca and the Assistant Secretary of Preparedness and Response (ASPR), BARDA, the HHS department overseen by Dr Robert Kadlec, the driving force behind the Manhattan Project for Biodefense. Though the final terms were to be agreed at a later date the contract stated that ‘The [US] Government anticipates adding up to $786,800,000 when the contract is definitized, for a total Other Transaction Agreements value of $1,200,000,000.’
The HHS contract required AstraZeneca to do a technology transfer to enable large-scale manufacturing of the drug substance and the drug product (the vaccine). AstraZeneca then outsourced the manufacturing of the drug substance to a company with longstanding links to Dr Kadlec, Emergent BioSolutions.
Much like the Pfizer negotiations with the UK Vaccine Taskforce and the US government which took place in July, https://www.conservativewoman.co.uk/how-uk-government-advisers-helped-pfizer-win-5-95billion-us-covid-vaccine-contract-part-2/ the AstraZeneca discussions were also taking place simultaneously. Did another UK Vaccine Taskforce expert adviser, Dr Richard Hatchett, the former director of BARDA, CEO of CEPI, and a close associate of Dr Kadlec, facilitate these discussions to obtain financing for the Oxford/AstraZeneca vaccine project and and extract something, say assistance with an authorisation, in return from the UK government?
The question of the propriety of Dr June Raine, the chief executive of the UK regulator MHRA but also a member of the Vaccine Taskforce Expert Advisory Board, regarding her willingness to be accommodating with respect to ‘some form of authorisation’ to kickstart the international rollout of the vaccine deployment phase, is also raised. As with the Pfizer/BioNTech product, it was the MHRA that recommended that the licensing minister, Lord Bethell, issue a TUA for the Pfizer/BioNTech product on December 2, 2020. The Oxford-AstraZeneca vaccine was also issued with a TUA under Regulation 174 which was signed off by the minister on December 30, 2020. Two days later, when the Brexit transition period ended, a conditional marketing authorisation could have been issued, but instead a calculated decision was made, perhaps due to the earlier transverse myelitis hiccup, to authorise the supply of an unlicensed medicine instead. The principal beneficiary of this was the company as TUAs have fewer strings attached. It certainly wasn’t the British people.
Next: Paula delves further into AstraZeneca’s Operation Warp Speed contracts.