In April 2020 Kate Bingham was invited by Sir Patrick Vallance, the government’s chief scientific advisor, to join the Vaccine Expert Advisory Group. In May 2020 she was appointed Chair of the UK Vaccine Taskforce (VTF), an idea originated by Patrick Vallance, reporting to the Prime Minister to lead UK efforts to find and manufacture regulated COVID-19 vaccines. Kate took a sabbatical from her work as managing partner at venture capital firm SV Health Investors to do this. After several months of tireless work and unprecedented collaboration between government and industry the UK kicked off its vaccination programme on 8th December 2020, the first Western country to do so. Kate’s six-month, unpaid appointment ended at the end of 2020 and together with Professor Sara Gilbert, a key scientist behind the AstraZeneca COVID-19 vaccine Kate was appointed a Dame Commander of the Order of the British Empire (DBE) on the Queen’s Birthday Honours List in June 2021 in recognition of work on vaccine design and delivery. Congratulations to both Dames! And THANK YOU.
At the 17th Anglonordic Life Science conference this year Kate Bingham discussed the actions of the VTF, how parties were brought together, and how they tackled the procurement, manufacturing, and distribution challenges they were faced with in what was a triumph of science and global collaboration. Watch Kate Bingham’s keynote and our key takeaways below.
Time is of the essence – it doesn’t have to be perfect!
The previous fastest development of a vaccine from recognition of a disease (measles) to a licensed vaccine in the US was 10 years and there was a clear need to speed up development of COVID-19 vaccines. The Prime Minister stressed that “time is of the essence, it doesn’t have to be perfect!” and set three goals:
- Secure effective COVID-19 vaccines for the UK
- Ensure successful vaccines are distributed internationally to all who need it
- Put plans in place to be better prepared next time around
How did it work?
The VTF recruited industry specialists who knew everything about vaccine discovery, pre-clinical, clinical, manufacturing, regulatory etc. and embedded that team of experts with government experts on for example, international collaboration, deployment and commercial negotiation, due diligence, triage, support and so on.
The VTF ring fenced a budget with the government to ensure a clear streamlined way of making decisions. VTF proposals were actioned by government very quickly. £900 million upfront secured the rights to different vaccines which was also used to fund manufacturing at risk, as well as carry out clinical trials on the safety and efficacy of those vaccines.
Diverse Portfolio of Vaccines
Eminent vaccine experts said that there was a 10-15% chance that any vaccine in the clinic at the time could be successful against SARS-Cov2, so a portfolio approach from the start was crucial. The VTF ordered early and bought doses of seven different vaccine candidates, across four different types of development processes, securing contracts for the two most advanced type of the adenoviral vaccines – the AstraZeneca/Oxford and Johnson & Johnson (Janssen) products – and the mRNA vaccines from BioNTech/ Pfizer and Moderna. The adenoviral and mRNA vaccines were the most advanced vaccines with respect to development but the least understood. The adjuvant protein-based vaccines and inactivated whole viral vaccines were better understood in terms of the technology and format, but at the time, still needed to complete clinical development and receive regulatory approval, indeed we still do not have an approved whole virus vaccine. A heads-of-terms was also agreed for AstraZeneca’s long-acting anti-body cocktail to act as potential prophylactic protection for highly immune-compromised patients unable to respond to a vaccine and those who need immediate protection. The VTF within 3-4 months converted heads of terms agreements with vaccine companies to full legal supply contracts.
The VTF created and launched the first National Citizen Registry for clinical trial volunteers on the NHS website to expedite the execution of clinical trials. A little under 500,000 people have already signed up to that registry of which over a third are elderly, over the age of 60 years (most at risk from infection). This enabled the UK to complete a phase 3 trial for the Novavax vaccine before the US even started a phase 3 study. The VTF also established the first Human Challenge Model for COVID-19. This involves the deliberate infection of young, healthy volunteers to understand how the virus infects and what the corelates of protection are that demonstrate that the vaccines are effective. Public Health England Porton Down and Oxford Immunotec also received funding to develop standardised assays to give rich immunological read outs to consistently compare different vaccines.
Scale up and reinforcement of the supply chain
It was important to bring manufacturing on shore in the UK to manage the scale up from clinical batch size to full population. One example of how this was achieved is that the VTF worked with and “supercharged” the existing vibrant specialist UK bioprocessing industry and expanded VMIC (Vaccines Manufacturing and Innovation Centre) to establish a rapid response unit by providing equipment to Oxford BioMedica and other manufacturers. By June 2020, the Department of Health started their deployment planning activities. The UK needs to be prepared for future pandemics. One long-term solution is to continue to support the smaller companies to enable them to manufacture, scale up and run their clinical trials in the UK.
Led by June Raine, CBE, so far, the Medicines and Healthcare Products Regulatory Agency (MHRA) – the UK’s medical regulator, has approved the Pfizer-BioNTech, Oxford-AstraZeneca, and Moderna vaccines for use under emergency authorisation in the UK. MHRA encouraged early, rolling vaccine reviews with the vaccine companies to speed up approvals. Approximately 45 million people have now received their first vaccine dose in the UK, that includes 84% of adults. Also, 61% of adults and nearly 33 million people have had 2 doses (data as of 28th June, see coronavirus.data.gov.uk/details/vaccinations) – a successful roll out handled by the Department of Health and The Joint Committee on Vaccination and Immunisation (JCVI).
Why did it work?
Kate believes that one of the aspects of success can be put down to her team having a Venture Capital mindset, or a Biotech mindset – working together as partners rather than adversaries to succeed rather than just focusing on price or process of doing things. We were very lucky that the government understood risk, accepted that many vaccines would fail, and the UK would likely lose money. This was unusual and a game changer leading to the portfolio approach of diversifying risk for vaccine development.
The VTF worked with an established, well-funded, co-operative, specialist industrial and academic base in the UK. The VTF had the right experts with the right amount of funding at the right time to support whatever activities were needed to execute flawlessly and quickly. Smaller companies were given greater support on manufacturing, infrastructure, and clinical trials to bring the science forward too.
Additionally, MHRA’s approach to rolling reviews of vaccine data dossiers enormously accelerated product approvals and there is no reason why drug regulators worldwide could not adopt this approach more broadly to get treatments to patients more quickly.
Kate is hugely optimistic about the changes in the UK and the broad willingness to collaborate globally to support people (several pharma companies were operating on a non-profit basis for the duration of the pandemic) and hopes that we continue to work in this collective way (whether for vaccines or therapeutics) for the benefit of patients. She also hopes to see the “game-changing” National Citizen Registry for trial volunteers to continue for vaccines and expand into therapeutics too, again helping everyone develop new, effective medicines for patients faster.