Inside the race to develop a COVID-19 vaccine

about 1 month ago Alex Voskou

Linked In Template Nov 2021 163

​Investigo Executive was honoured to host a talk from Nick Elliott CB MBE, Former Director General of the UK Vaccine Taskforce, on Tuesday 23rd November. Joined by our clients and partners at South Place Hotel in London, Nick provided a fascinating internal perspective on the success of the UK’s COVID-19 vaccine programme and discussed the lessons organisations can learn from this.

The vaccine story

As the biggest global health crisis in generations unfolded at the start of 2020, it was thought that an effective test and trace system would represent our best chance of monitoring and ultimately restricting the spread of COVID-19. For many reasons, the widescale development and distribution of a vaccine couldn’t have been further away from the government’s thoughts: no vaccine had ever been successfully developed for any human coronavirus; COVID-19 had traits which were not yet understood – and viruses mutate; the most advanced clinical vaccine formats had never been approved by regulators; there were poor immune responses in the elderly; demonstrating statistical clinical protection of a vaccine would require ongoing COVID-19 infection; and the UK did not have the required bulk manufacturing capacity for advanced medicines.

Test and trace ultimately didn’t get us out of the pandemic and despite the many challenges involved, vaccines have proven to be the answer not only from a health perspective, but also from an economic and political perspective. With no long term experience or safety data to work from, and with the required drugs not yet in existence, the challenge was how to find, manufacture and distribute these drugs from scratch. Despite its obvious urgency, attempting to rush clinical development could introduce risks to vaccine safety down the line. So we had to do it quickly, and we had to do it right.

Building the team

Simultaneously a programme of research and development, manufacturing and logistics, and deployment, the quest for a vaccine required the input of a wide range of leading experts. The vaccine expert advisory panel was formed by Sir Patrick Vallance in March 2020. The Bioindustry Association (BIA) manufacturing group was formed in support, conducting a capacity audit which would form the key baseline for future decisions. The nascent VTF assembled in the Department for Business, Energy and Industrial Strategy (BEIS) a month later.

Kate Bingham was appointed Chair, and Nick appointed Director General, in May. It was during a socially distanced chat in Green Park that Nick and Kate put together their plan for success: a multidisciplinary team of experts in life sciences, vaccines and health, supported by programme and project management, communications, commercial and logistics experts. The taskforce had to be more than an advisory panel; it had to be a delivery group, too. By August, the team had grown from six to 200 specialist secondees from industry, the civil service, the military, and consultancy.

“We were building the plane as we were flying it.” Nick Elliott

The goals

Secure access to promising COVID-19 vaccines for the UK population as quickly as possible

Europe initially made the mistake of treating the vaccine as a commodity procurement for a drug – but as these drugs did not exist, this situation was different. There was uncertainty over what was meant by “the UK population” – would this apply to the over 70s? Over 60s? Over 50s? Healthcare workers? Firefighters? The main consideration was time.

Make provision for the international distribution of vaccines

The Oxford-AstraZeneca vaccine was the only vaccine being distributed at cost to the world. It was part of a three-way deal with the UK Government and a plan was established for supply to the rest of the world.

Establish a long term strategy to prepare the UK for future pandemics

Everything the taskforce did was with an eye on legacy provision; on leaving us in a better position for anything similar that might happen in the future.

These goals were delivered through six workstreams: drug discovery and procurement; trials, testing and regulatory; manufacturing and supply; vaccine deployment; international collaboration; and legacy. At the same time, it was about finding out how trials could be accelerated. What would the regulator need to approve quickly? Where did the taskforce need to make a potentially risky investment in manufacturing and what raw materials and ancillaries needed to be secured early?

The plan for deployment began right at the outset. The strategy was to diversify modality, immunogenicity and delivery to build a vaccine portfolio, which was then narrowed down to the smaller number of vaccines now available.

The leadership team

The taskforce’s leadership team was built from the top-down, in a venture capitalist approach. The experts who had been brought in used their contacts to bring in the next levels, eventually building a capable, agile and diverse 11 person steering group sitting at the heart of the taskforce.

The urgency with which decisions needed to be made was very much at odds with the complexity of government processes and the sheer mass of governance involved, encompassing programme boards, delivery boards, risk groups, the COVID PMO office, Cabinet Office reviews, DHSC reviews, Number 10 reviews, IPA oversight and NAC oversight. Agility was key to facilitating constant risk-based decision-making and deal completion. The taskforce ensured this agility by:

  • Opening up the Monday steering group to every single government department, using Fridays to focus on deployment with the NHS, Joint Committee on Vaccination and Immunisation (JCVI), Public Health England and the military.

  • Gaining agreement to set up a joint ministerial panel. Pretty much every decision needed sign off by the BEIS, the Department of Health and Social Care (DHSC), the Cabinet Office and the Treasury. This single, decision-making panel brought all ministers together at short notice and its decisions were final.

Defeating disinformation

The taskforce worked closely with international agencies and the UK press, mainly investigative journalists, to identify and counter vaccine disinformation through scientific led information, interviews and podcasts. It was also supported by a cross government security and intelligence plan to both physically protect our vaccine supply and to help counter the mass of disinformation from a wide variety of sources, including state actors.

As a result of distracting media pressure in November, Nick spent considerable time answering press and parliamentary questions, and preparing ministers. But better news came in December with the first trial result of the Pfizer-BioNTech vaccine, which suggested it would be incredibly successful.

Approval

On 2nd December, the vaccine was approved by the UK. But there were still challenges to overcome in distributing a vaccine which required specialist cold chain storage and handling techniques. Through the early stages of distribution, the taskforce worked through these challenges collaboratively with the supplier. It was decided that the vaccine deployment would be health led, with a mix of healthcare providers – hospital trusts, GPs, pharmacies – providing a range of targeted facilities supported by a large number of volunteers.

On 8th December, Margaret Keenan became the first recipient of the Pfizer-BioNTech vaccine, followed on 4th January by Brian Pinker receiving the Oxford-AZ vaccine.

Outcomes

Massive reduction in death rates following vaccination

The vaccine programme has broken the link between infection, hospitalisation and death. As of 23rd September 2021, the COVID-19 vaccination programme had directly averted over 230,800 hospitalisations, prevented over 126,000 deaths and more than 24 million infections, according to Public Health England.

The civil service is disincentivised to focus on outcomes, and widely criticised if it doesn’t follow the right processes. But the focus and success of the vaccine programme has been a huge governance lesson. The JCVI’s recommendations on who to vaccinate, in what order and to what timescales were totally validated. These included single dose vaccinations of as many vulnerable people (by age priority) as possible and delaying the second dose, which is now proven to improve immune response. Heterologous boosters, which involve administering a different vaccine jab, are increasing immunogenicity.

Scale up and manufacture

Building flexible bulk onshore production for multiple vaccine formats, the VTF has supercharged the existing vibrant specialist UK bioprocessing industry.

Enhanced UK vaccine clinical development capability

  • The launch of an NHS Citizen Registry enables rapid recruitment of volunteers, which currently stand at over 500,000.

  • Human challenge studies have been conducted for next generation vaccine trials.

  • Standardised assays offer rich immunology readouts.

Summary – why did it work?

A venture capitalist mindset

  • Viewed affiliates as partners, not adversaries

  • Accepted risk – and mistakes – and willing to stop things early if they were not delivering

  • Portfolio approach

  • Value-add buyer – provided support to optimise for success

  • Leveraged experts – tranche funding, executed quickly and flawlessly

Leveraged long term industrial and academic investment by government

  • Started with a vibrant industrial and academic base

Mandate for speed over perfection, empowered expert team

  • Mandate from the PM

  • Embedded experts into government

  • Streamlined governance and decision making

Innovative regulator – Medicines and Healthcare products Regulatory Agency (MHRA)

  • Rewrote the rules e.g. rolling reviews of incomplete data

  • Thoughtful and cooperative; driving for success

Summary – a governance lesson

  • Set up for success – get the right team and organise it effectively

  • Define success from the start – focus on vision, outcomes and whole value business case

  • Agility as a way of being – find the best way to deliver within your own environment

  • Joint client and supply chain success – collaboration, collaboration, collaboration

  • Keep your sense of humour – and support your people

Conclusion

There is much we can learn about successful programme and project delivery, especially in a government environment. But a lot of it is about behaviours, incentivisation and the management of risk. We had the benefit of a burning platform, an opportunity to make government understand and quantify the value (and cost) of time. The question is now about how we embed change in business as usual. We need to create a culture that makes success the norm, with clear and shared success criteria, a sense of urgency, transparency of progress, success and failures, appropriate risk appetite and positive incentivisation.

Many thanks to Nick for a fascinating talk and to everyone who attended. If you’re looking for an executive level role or for talented senior professionals to strengthen your business, please get in touch.