‘Vaccine makers like Serum Institute are key — they need a hotline to US, EU authorities’

Oxford University

scientist Alexander Douglas led the manufacturing development of the

AstraZeneca

Covid-19

vaccine

. Sharing his insights with

Times Evoke

, Douglas discussed the challenges and the impetus involved:
What made you think about a ‘billion dose supply chain’ for the Covid-19 vaccine in March 2020, when the full implications of Covid-19 weren’t clear?
From January 2020, it actually seemed quite clear that there was going to be a global pandemic — the R-value and case fatality rate were higher than any flu pandemic since the Spanish flu in 1918, which killed many millions. When it was known that about 80,000 people had been infected in China, and flights around the world had been continuing, it seemed impossible to me that a virus this contagious was going to be contained — it took ‘back of an envelope’ calculations to see that the severity of the illness and the likely rate of infection could overwhelm even the best health systems.

From February 2020, we were thinking about manufacturing millions of doses. We kept pushing to scale up — it was essential to think early on about the challenges in making a billion doses.

The role of science and the laboratory have proved crucial in the evolution of the Covid-19 pandemicYou transferred Oxford University’s vaccine knowledge to manufacturing facilities in the UK to start production — can you tell us about that?
My research group started work on scaling up our manufacturing process and transferring it to large-scale facilities in February 2020. The first ‘moderately large’ batch, made in 200 litres of cells, was available for use in clinical trials in early August. The first really large batch, made in 2000 litres of cells, was available in end-December 2020 — it took nearly a year to reach this scale

We faced big hurdles as well, including persuading funders to support us at the start, finding the right ‘big pharma’ partner which shared our vision of supply for low and middle-income countries, adapting the process to fit available manufacturing facilities — we had to change it because our original idea wasn’t going to fit — and the supply of some raw materials. Each vaccine needs different raw materials, from hundreds of ingredients to disposable containers, tubes and filters. For our vaccine, there are challenges in getting enough ‘culture media’ — the nutrients in which the cells that make the vaccine are grown — and filters used in purifying the vaccine.

How important was vaccine equity to you in your efforts?
Equity has been a huge consideration for me and the Oxford vaccine team right from the beginning. Our non-pandemic ‘ day jobs’ are in global health, developing vaccines against diseases like malaria and rabies, so we already had strong relationships with partners worldwide. My team was working with low and middle-income country manufacturers, including the Serum Institute, from March 2020 before we spoke to big Western pharma companies. We also anticipated that countries would find it very difficult to export vaccines until they had controlled their own outbreaks, so it was critical to have manufacturing sites in multiple countries.

When we were choosing big multinational pharmaceutical companies to work with us as partners on this, a key consideration was which of them would be willing to continue with that vision and ensuring that the vaccine was kept at an affordable price.

You’ve said IP waiver announcements are a ‘distraction’ from the real issues constraining vaccine equity — what are these issues?
The main issues are an equitable distribution of the doses which have been purchased by rich-country governments and the supply of important raw materials to manufacturing facilities. Governments need to cooperate internationally to overcome raw material shortages — we need an international ‘Operation Warp Speed’ for producing raw materials.

The best hope to increase vaccine supplies is for governments to actively help pharma companies and raw material suppliers. Facilities like the Serum Institute of India are now important to the whole world in mitigating the pandemic — Serum should actually have a hotline to the US administration and the

European Commission

.

Serum is reliant on materials from the US and Europe, both of whose economies will benefit massively when vaccines bring the global pandemic under control. Raw material supply should be treated like steel for making weapons in a war — except, in this war, we’re not in competition. The whole world benefits from increasing vaccine supply.

It would also be helpful for governments and international organisations like Covax to place contracts now for large amounts of vaccines into the future or 2023 onwards. That will give vaccine manufacturers and raw material suppliers the security they need to scale up — and it’s also better to end up with too much vaccine than not enough.

Given the rise of variants, how likely do booster shots seem? And how could that in turn impact vaccine equity?
This is both a difficult and important point. Personally, I think it is quite likely that booster vaccines will be needed to maintain high levels of vaccine efficacy against mild infection. But if rich countries start giving boosters to their populations, that’s bad news for supply to low and middle-income countries. It adds to the need to scale up manufacturing now.

What are the latest findings in Oxford University’s Covid-19 vaccine research and your effort to make a possible nasal spray?
As my colleagues’ latest research shows, it’s clear there is substantial protection after the first dose of the AstraZeneca vaccine. The best protection is achieved with a second dose after a longer interval (8-12 weeks). This has been published in The Lancet — it’s a very reliable result.

The nasal spray research is at an early stage of clinical trials now. A spray may turn out to be more effective than an injection and also easier to manufacture if a smaller dose can be used. It might be available by year-end, if there’s urgent investment in the clinical trials.

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