My first-hand experience working with the company developing and manufacturing the AstraZeneca ‘vaccine’
Raises some interesting questions...
[Note: Many of the links here are missing - can only assume they were taken down since posted three years ago]
AstraZeneca did not develop or manufacture the adenovirus vaccine
I was first involved with the company that developed and manufactured the AZ marketed gene therapy product in 2013. It was in the days of the coalition Government, and it related to a funding call sponsored by Sir Vince Cable, who then had responsibility for the Department for Business, Innovation & Skills.
The call was titled the Advanced Manufacturing Supply Chain Initiative (AMSCI - pronounced am-ski). It had gone through two rounds of applications and no company in life sciences had been successful. When the third round was announced, I was contacted to help out in finding a company to submit a bid, and frame it so that it met the criteria for an advanced manufacturing bid.
If you had a chance to read, you will know the bid was for Oxford Biomedica (OXB). OXB was located at a site I had worked at as a permanent employee twice before—for British Biotech and OSI Pharmaceuticals (now Astellas). It was, and still is, adjacent to the site where BMW manufactures its Mini’s. We used to watch them rolling out into the massive car park, all colours and configurations, bright and shiny waiting for their new owners.
Anyway, enough reminiscing!
By way of background, I was commisioned by OXB to consult on the AMSCI bid.
I had roped in the world-class manufacturing group at Cranfield University (I’m an Alumni) to bring academic rigour to proceedings, and the Heart of England NHS Foundation Trust (HEFT), through my Cranfield connections.
This was to be a radical approach to the development of new therapies, where healthcare professionals would be central to the process of development.
During construction of the bid, HEFT arranged for one of its eye surgeons, formerly of the renowned Moorfields Eye Hospital, to advise on an ocular product OXB was working on. The insights were far more revealing than the market research that had previously been carried out.
The approach we took mirrored that of all advanced manufacturers, whereby end users of their products are widely consulted during the design and development stage. That is often termed seeking the Voice of the Customer (VoC), and forms the basis of the product as it is manufactured for commercial use.
Also involved in the project was UK Government’s (through Innovate UK) Cell & Gene Therapy Catapult, albeit OXB dealt with them directly on technical and science considerations.
OXB working with Novartis
At the time, OXB was working with Novartis on developing a gene therapy product for blood cancers (CAR T), details in the Press Release below:
Here is an extract:
“OXB will manufacture lentiviral vectors expressing CTL019/CART-019. The manufacturing contract has an initial three year term. Additionally, OXB has granted Novartis an exclusive licence for the worldwide development and commercialisation of all Chimeric Antigen Receptor (CAR) T cell products arising from the process development collaboration.”
The AMSCI bid was based on innovations and process improvements in the supply chain for the LentiVector®.
Cutting to the chase, the bid was successful and OXB received the funding sought, see the Press Release below:
Oxford BioMedica Wins Significant Funding via a Competitive Award from UK Government’s Advanced Manufacturing Supply Chain Initiative
Here is an extract:
Oxford, UK – 11 September 2013: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), the leading gene-based biopharmaceutical company, announces that it has been selected as a winner of a funding award under the UK Government’s Advanced Manufacturing Supply Chain Initiative (AMSCI), in recognition of the Company’s potential to become a world-leader in Advanced Therapy Medicinal Product (ATMP) manufacture and supply chain expertise.
Oxford BioMedica led the successful bid with four other UK-based participants: the Heart of England NHS Foundation, Cranfield University, Cell Therapy Catapult Ltd and Biotec Services International Ltd (together, the “consortium”). Subject to due diligence and final confirmation by Birmingham City Council, the consortium has been awarded a £2.4 million grant, of which Oxford BioMedica will receive £1.8 million, and a £5.3 million loan to Oxford BioMedica which is repayable by March 2017.
Not long afterwards, there was an invite to join a meeting at BIS headquarters in London. It was chaired by a senior Government civil servant, with representatives from the Office for Life Sciences, Cell & Gene Therapy Catapult (CGTC), and others, including the Director of Manufacturing at OXB, who I had worked closely with, and me.
The subject of the meeting was to discuss how to build on the OXB success. As the meeting progressed, it became clear that the then CEO of the CGTC had rather different ideas to me. Never able to keep my mouth shut, I expressed my contrary view.
It did not go down very well!
That was the last of my involvement with OXB, and any further invitations to Government think tanks. The Director of Manufacturing was fired around the same time.
From then on, there was much Government attention given to OXB and the topic of gene therapy, which I followed with interest.
Chief Secretary to the Treasury pops in
The then coalition Government was delighted with the PR, to the extent that Rt Hon Danny Alexander, Chief Secretary to the Treasury, paid OXB a visit:
Chief Secretary to the Treasury visits Oxford BioMedica
The Press Release states: “The funding was awarded to the Company to support Oxford BioMedica in becoming a world-leader and UK Centre of Excellence in the manufacture and supply chain of gene and cell based therapies.”
OXB signs supply agreement with Novartis
Things progressed with the approval of of Novartis’ product, to the extent that OXB signed a $100 million supply agreement with Novartis:
Oxford BioMedica Announces a Major Supply Agreement
The Press Release states:
“[OXB] today announces that it has signed an agreement with Novartis for the commercial and clinical supply of lentiviral vectors used to generate CTL019 (tisagenlecleucel) and other undisclosed Chimeric Antigen Receptor T cell (CART) products. The agreement builds on the collaboration announced between the Group and Novartis in October 2014 and anticipates the commercial launch of CTL019 later this year.”
Kymriah approved by FDA.
Novartis’ product, which had been named Kymriah, was approved by FDA in August 2017. This is a previous post including some comments on Kymriah:
Note this extract which covers the current safety warning on the Kymriah labelling:
“WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab, or tocilizumab and corticosteroids
Neurological toxicities, which may be severe or life-threatening, can occur following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care as needed
KYMRIAH is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS”
That doesn't build confidence in the safety of gene therapy based vaccines, does it, given the vast scale of the vaccination programmes?
OXB and the SARS-CoV-2 injections
OXB went on to develop, manufacture and commercially supply the viral vector (adenovirus drug substance) for the AstraZeneca SARS-CoV-2 injections, as the Press Releases below recount chronologically:
8 April 2020
Oxford Biomedica joins Consortium to rapidly develop a COVID-19 vaccine candidate
13 May 2020
Oxford Biomedica receives MHRA approval for the first two manufacturing suites in Oxbox
20 July 2020
1 September 2020
6 October 2020
Oxford Biomedica receives MHRA approval for fourth manufacturing suite in Oxbox
23 November 2020
Oxford Biomedica notes AstraZeneca’s AZD1222 met primary efficacy endpoint in preventing COVID-19
30 December 2020
18 January 2021
Prime Minister Boris Johnson formally opens Oxford Biomedica’s manufacturing facility Oxbox
1 July 2022
Oxford Biomedica signs new three year agreement with AstraZeneca
In summary, this tells us the AstraZeneca SARS-CoV-2 injections were developed, manufactured and supplied not by AstraZeneca or Oxford University, who would have been passive observers only. Remember, AstraZeneca has no capability to develop or manufacture gene therapy products and Oxford University, as a research centre, certainly doesn’t.
What questions does this raise?
You may have questions or comments that arise from this, so feel free to:
Next time I’ll add my thoughts on the AstraZeneca SARS-CoV-2 injections, especially in relation to the eye-watering speed of development, virtual inspections and MHRA GMP approvals, plus take a look into the mRNA injections…
All very interesting. But why would I ever need a vaccine for anything?