Impact case study database

ChAdOx1 was patented in 2012 (PCT/GB2012/000467) and has been used in 11 vaccine programmes, including for malaria, influenza, Chikungunya, and MERS, showing a good safety profile and high immunogenicity. Recognising the potential for vaccine development using ChAdOx1, Gilbert and Hill founded Vaccitech in January 2016 to develop vaccine and T cell therapeutic products to improve global health. Vaccitech was spun out from the University of Oxford, and licensed intellectual property rights to the ChAdOx1 technology [1], raising GBP10,000,000 investment from Oxford Sciences Innovation (OSI) [A]. Vaccitech has subsequently attracted additional investment of GBP57,000,000 between Nov 2017 and Dec 2020 enabling programme development [A]. Vaccitech has grown from 1 employee in May 2017 to almost 50 employees in Dec 2020 [A], contributing to business development in the local area and has subsidiaries in Australia and the US to support global operations [A]. HAV Vaccines in London licensed ChAdOx technology from Oxford University Innovation (OUI) to develop a vaccine to treat and prevent infection by Mycobacterium avium subspecies paratuberculosis (MAP) which is responsible for the chronic gut inflammation in patients with Crohn’s Disease. A phase 1 study on healthy volunteers [Bi] showed no safety concerns and patients with Crohn’s Disease are being recruited into a follow-on phase 1 trial [Bii]. Aelix Therapeutics in Spain has also licensed the ChAdOx technology from OUI and is using the technology to develop a therapeutic vaccine for the treatment of HIV. Aelix Therapeutics launched a phase 1, randomised, double-blind, placebo-controlled safety, tolerability, and immunogenicity clinical trial in 45 individuals with HIV in July 2017 [C].

Between 23 April and 4 November 2020, Oxford led clinical trials in geographically and ethnically diverse populations over three continents. 11,636 individuals were vaccinated with ChAdOx1 nCoV-19 in clinical trials in the UK, Brazil, and South Africa. Based on interim efficacy results [6], these individuals now have a 70.4% reduced risk of developing COVID-19 and vaccinated individuals are protected against hospitalisation with COVID-19. In August 2020, AstraZeneca began a Phase III clinical trial in the US to determine the safety, efficacy, and immunogenicity of AZD1222 [D], enrolling 32,449 participants, with two thirds receiving the COVID-19 vaccine and one third the placebo. Data from the US trial showed that the vaccine reduced risk of severe COVID-19 by 100%, of clinical COVID-19 by 76% and was 85% effective in older adults.

On 30 December 2020, following review of the Oxford clinical trial data by the Commission on Human Medicines, ChAdOx1 nCoV-19/AZD1222 was authorised for emergency use supply in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) [E], the first viral vectored vaccine against COVID-19 to be granted approval in Europe. Oxford research [6] was used to inform the Joint Committee on Vaccination and Immunisation (JCVI) decision on dosing regimen for the Oxford vaccine, and for the Pfizer-BioNTech mRNA vaccine that had received regulatory approval in the UK on 2 December 2020 and whose clinical trial data used a three-week dosing interval. Oxford research [6] showed that a longer interval between the first and second vaccine dose promoted a stronger immune response. On 31 December 2020, the JCVI recommended a two-dose schedule for the Pfizer-BioNTech and Oxford-AZ vaccines, with a maximal interval of 12 weeks between the first and second dose for both vaccines, based on the likelihood that immune responses to both vaccines were similar [F]. The Committee recommended prioritising delivery of the first vaccine dose as this was highly likely to have a greater public health impact, allowing more people to be vaccinated, and reduce the number of preventable deaths from COVID-19 [F]. Emergency use authorisation of ChAdOx1 nCoV-19/AZD1222 was granted in Argentina and El Salvador on 30 December 2020, and in Dominican Republic on 31 December 2020.

The UK, through the UK Vaccine Taskforce (VTF), was the first country in the world to secure access to the Oxford vaccine, securing 100,000,000 doses (enough for 50,000,000 people) in May 2020, 7 months before the vaccine received regulatory approval. The former Chair of the VTF wrote that,

“The portfolio of Oxford’s research on ChAdOx viral vectored vaccines was a critical factor for the VTF’s decision to secure 100 million doses of the Oxford/AZ vaccine before it had received regulatory approval” [G].

Guaranteeing doses of the Oxford vaccine helped the UK government meet its goal of securing access to COVID-19 vaccines for the UK population as quickly as possible [G].

On 30 April 2020, the University of Oxford and AstraZeneca signed a landmark agreement for the global development, manufacture, and distribution of ChAdOx1 nCoV-19/AZD1222 [Hi]. Of crucial importance to the Oxford/AstraZeneca partnership was the joint commitment to ensure broad and equitable access to the vaccine on a not-for-profit basis for the duration of the pandemic and in perpetuity to low and middle income countries (LMICs) [Hii]. In June 2020, AstraZeneca was the first global pharmaceutical company to join COVAX (COVID-19 Vaccines Global Access), a global initiative led by CEPI, GAVI and WHO, aiming to distribute 2 billion vaccine doses to 92 LMICs at no more than USD3 per dose. As of 31 December 2020, agreements were in place for the supply of 2,678,900,000 doses of the Oxford vaccine worldwide [I], almost twice as many as any other vaccine developer globally, and notably with approximately half committed to LMICs via COVAX [J]. The Oxford vaccine has the significant benefit of being easy to manufacture, store in a fridge and distribute, allowing it to be rapidly deployed in LMICs.

AstraZeneca confirmed,

“The ChAdOx platform was particularly attractive for us as it enabled the rapid development and deployment of novel vaccines with a manufacturing process and supply chain that would enable the equitable and global rollout we all envisaged, without some of the limitations of mRNA vaccines” [K].

Alongside expanding manufacturing capacity at AstraZeneca, the collaboration with Oxford also resulted in growth of

“a significant preclinical, clinical capability to support the vaccine programme. This now provides the platform for next generation vaccine development, not just for SARS CoV-2 but potentially for other important viral infections" [K].

The former Chair of the VTF said “ The development of the Oxford vaccine helped drive the growth of the UK’s vaccine capability” [G]. In May 2020, the UK government announced GBP131,000,000 investment to accelerate construction of the Vaccines Manufacturing and Innovation Centre (VMIC) at Harwell, Oxfordshire, and to create a virtual VMIC which could produce vaccine doses whilst VMIC was under construction [Li]. As of 31 December 2020, three of the seven most advanced COVID-19 vaccines were being manufactured in the UK, including the Oxford vaccine [Lii].

The former Chair of the VTF stated,

“The development of the Oxford vaccine has stimulated new investment in skills and training and dramatically expanded the UK’s capacity to manufacture and fill vials across a range of bioprocessing and fill finish companies throughout the UK” [G].