In her TCW article last week on the UK and US vaccine supply deals Paula Jardine reported on a Faustian bargain in which American funding for the Oxford AstraZeneca Covid vaccine seems to have been secured from the US Operation Warp Speed supply contract in a quid pro quo for assistance from the UK with an authorisation for the Pfizer/BioNTech mRNA ‘vaccine’. Today she delves further into these contracts.
UNDER AstraZeneca’s US Operation Warp Speed contract, money flowed through to a vaccine manufacturing company called Emergent BioSolutions, a company with a long-standing association with the Assistant Secretary of Preparedness and Response (ASPR) in the Health and Human Services Department, Dr Robert Kadlec. During his tenure as Homeland Security Director of Biosecurity Policy in the administration of President George W Bush, Dr Kadlec haddirected billions of dollars to them for the manufacture of anthrax vaccines to be stockpiled for use in emergencies under the 2004 Project BioShield Act.
Kadlec did not declare his links to Emergent Biosolutions to Congress during the confirmation process when he was appointed ASPR in 2017. Yet he was working for Emergent BioSolutions as a consultant when he established a Blue Ribbon Panel on Biodefense in 2015 which Emergent BioSolutions helped to fund. This organisation, which became the Bipartisan Biodefense Commission, held a forum on a 21st century Manhattan Project for BioDefense in July 2019. This project was conceived as a biotech ‘big bang’, designed to rapidly expand vaccine manufacturing capacity while simultaneously introducing new vaccine manufacturing technologies such as mRNA and ‘updating’ the regulatory approvals process to get new products on the market faster.
Robert G Kramer, Emergent BioSolutions CEO, testified to Congress in July 2021 that his company had been directed to work with AstraZeneca by the US Biomedical Advanced Research and Development Authority (BARDA): ‘After awarding the contract they [HHS/BARDA] directed us to immediately begin work with AstraZeneca to tech transfer in, or to transfer their candidate into our facility, scale up the manufacturing process, and begin the work.’
Emergent BioSolutions had secured a $220million contract with BARDA in 2012 to establish a Centre for Innovation in Advanced Development and Manufacturing (CIADM) in Maryland, where it was to expand its manufacturing facilities for pandemic influenza vaccine. Daniel J Abdun-Nabi, then president and CEO of Emergent BioSolutions, said: ‘We are honored by the US government’s continued confidence in us, which is founded on our longstanding track record of being the premier biodefense developer and supplier of medical countermeasures. This award underscores Emergent’s core competencies not only in product development and manufacturing, but also our expertise in contracting with the US government and navigating the regulatory process. This partnership truly allows us the opportunity to fulfil our mission – to protect life.’
But as of 2019, Emergent’s Maryland factory hadyet to be licensed as a Good Manufacturing Practice facility. A June 2020 report for the US Food and Drug Administration revealed that though the company had inadequate contamination control strategies in this factory, HHS still awarded the company a further $628million contract on June 1, 2020 to advance domestic manufacturing capabilities for Covid vaccines. The US General Accounting Office later reported that under Operation Warp Speed, the US Army Corp of Engineers was overseeing construction projects to expand vaccine manufacturing capacity.
On June 11, 2020, the first technology transfer contract between AstraZeneca and Emergent BioSolutions worth $87million was announced. A second valued at $174million was agreed on July 27, 2020. On July 31, the Other Transaction Authority (OTA) base contract between AstraZeneca and HHS was modified but no details are publicly available. US Army contracting subsequently agreed a final contract with AstraZeneca on October 28, 2020 requiring it to ‘Conduct Phase 3 clinical trials and demonstrate the ability to manufacture and distribute 100 Million (M) doses of the ChAdOx1 nCoV-19 vaccine (now referred to as AZD1222) to the United States Government to prevent the general population from developing symptoms of the COVID-19 infection.’
Under Operation Warp Speed contracts, Emergent BioSolutions was manufacturing both the AstraZeneca and J&J adenoviral vector covid vaccines in its Maryland factory. Janssen vaccines, J&J’s European subsidiary, was Oxford’s previous collaborator on its CEPI-sponsored adenoviral vector MERS vaccine project. Kramer appeared before Congress in 2021 aftermillions of doses of AstraZeneca and J&J SARS-CoV-2 vaccines were cross-contaminated and had to bedestroyed. He explained the reason for the problems with the factory saying, ‘Despite our own investment of more than $200million, the expected pipeline of government task orders to utilize the [CIADM] facility persistently fell short of what was needed to reach full operating potential.’
The Oxford/AstraZeneca vaccine never obtained the necessary Emergency Use Authorisation (EUA) from the US Food and Drug Agency (FDA). Instead the AstraZeneca vaccines manufactured by Emergent BioSolutions for the US Department of Defense were distributed to Mexico and Canada before they were quietly withdrawn when the product proved to be the least safe of all the Covid vaccines.
UK government funding also supported manufacture of the Oxford-AstraZeneca vaccine in the UK. Business Secretary Alok Sharma said: ‘This new money [£84million on May 17 ] will help mass produce the Oxford vaccine, so that if current clinical trials are successful, we have dosages to start vaccinating the UK population straight away.’ He said they anticipated the first 30million doses would be available in September.
Sharma also announced a further £94million would go to the Vaccine Manufacturing Innovation Centre (VMIC) which was established in 2018 by Oxford University in partnership with Imperial College London and the London School of Hygiene and Tropical Medicine. It was spent speeding up the completion of the facility. In total the Vaccine Taskforce committed £405million to projects relating to vaccine manufacturing.
Work on developing the manufacturing method itself began in advance of the Oxford-AstraZeneca April 2020 phase 1 trials. The Oxford University project leader Dr Alexander Douglas said, ‘We have been preparing for large-scale manufacturing of our vaccine candidate [ChAdOxInCoV-19] since February. This funding enables manufacturing to start immediately, and so will make vaccine available as soon as possible, while adhering to the most stringent safety standards.’
On December 30, 2020, two days before the end of the Brexit transition period, the licensing minister Lord Bethell issued a TUA for the Oxford AstraZeneca vaccine as well – the vaccine that proved to be the most dangerous of all. The European Medicines Agency (EMA) issued a conditional marketing authorisation on January 29, 2021, but the vaccine was loudly and quickly withdrawn in the EU. By March 2021 a dozen countries had suspended its use due to concerns over blood clots. The UK restricted its use to people aged over 30 on April 7, 2021 and stopped using it after it was not deemed suitable for the booster programme.
Impropriety cries out. At the American end, large sums of money flowed, both directly and via AstraZeneca, to Emergent BioSolutions, a company with a long-standing association with the ASPR Dr Robert Kadlec. More concerningly from the UK perspective, the $1.2billion AstraZeneca Operation Warp Speed contract looks suspiciously as though it was the quid pro quo for a hurried temporary use authorisation for the Pfizer/BioNTech mRNA vaccines, the new rapid response ‘plug-and-play’ vaccine platform the US biodefense hawks wanted to modernise vaccine manufacture with.
In other words, the US government largely financed the development of the Oxford-AstraZeneca vaccine in return for UK government assistance with Kadlec’s Manhattan Project. It appears that these arrangements were made by the UK Vaccine Taskforce or on behalf of it by members of its expert advisory board set up by the Department of Business, Energy and Industrial Strategy (BEIS). Dr Richard Hatchett, the CEO of CEPI and former director of BARDA was the expert advisory board member best placed to have coordinated this.
AstraZeneca already had skin in the Covid vaccine game. It was an early investor in Moderna and between 2013 and 2019 it built up a 7.65% ownership stake in the company. At some undisclosed point during 2020, as the value of Moderna shares rose, it sold its entire holding for nearly $1billion, a significant profit on its $290million investment. Once the Pfizer/BioNTech mRNA vaccine was authorised, an authorisation for Moderna’s mRNA vaccine was a foregone conclusion.
As Hedley Rees, a life sciences manufacturing expert, has pointed out, the MHRA lost the expertise to evaluate drugs in 1995 when the function was centralised via the creation of the European Medicines Agency. Furthermore, he explained that Dr Raine, the CEO of MHRA who sat on the Vaccine Taskforce’s expert advisory board, has no actual experience in drug approvals. She is a post-marketing pharmacovigilance expert. It is now known that the Pfizer product MHRA authorised in December 2020 was not identical to the one tested in the BioNTech sponsored clinical trials. The willingness of the MHRA to accommodate this arrangement was reckless to the point of negligence.
On the day Pfizer agreed its original $1.95billion US Operation Warp Speed deal, Sir Jeremy Farrar, another UK Vaccine taskforce expert adviser, testified before a Parliamentary Committee: ‘I personally think that the most important mortality statistic that needs to be looked at is overall excess mortality. It is the direct effects of Covid and it is the secondary consequences with other people tragically dying as well. Mortality rates are crucial, but I prefer the statistic for looking at that to be overall mortality compared with previous years at this time.’
Well, Sir Jeremy, judging by your preferred metric, overall excess mortality did not increase until after the Covid vaccines you championed were deployed on the all-too-trusting public. They have been and are a disaster. There needs to be a full investigation of the role that you and your fellow Vaccine Taskforce advisers played in making the Covid vaccine Faustian pact.