Vaccine project management – a race against time

The urgency to find a coronavirus vaccine is compressing years of research into weeks for these life-saving projects, writes Rachael Pells

Developing a successful vaccine for COVID-19 is now occupying some of the world’s sharpest minds. But the road ahead is far from straightforward. Scientists face huge time-scale pressures, and navigation is especially complicated when traditional planning strategies no longer apply.

The unpredictable nature of the disease means project managers are unable to plan to the same measures they once might have. So how do we go about achieving such a complex and high-stakes mission when the only deadline leaders have is ‘now’?

“A global public health crisis is not business as usual,” says Tarja Huuskonen, CEO at life sciences project management consultancy Action for Results. Leadership, resilience and a “focused pursuit of the end goal” are crucial, she says, and team leaders will need to build a strong network of partnerships and alliances – often with competitor groups and across boundaries.

“From a global perspective, having a prioritised pipeline of vaccine candidates is also important,” Huuskonen says. “While several global collaborations are in place, questions about prioritisation and the ability to refocus resources and funding quickly appear.”

Given that social distancing measures are forcing office teams to fully coordinate work online, “another challenge is to quickly learn virtual facilitation of work – truly working virtually, and not just meeting virtually,” she explains.

How the Jenner Institute made a head-start

At Oxford University’s Jenner Institute, immunologists are creating a ‘recombinant vector vaccine’, designed to work by embedding a string of genetic coding from the coronavirus into an existing chimpanzee virus that is harmless to humans.

The potential benefits of this relatively new type of vaccine development is that it uses an existing structure, and is believed by some experts to be safer – allowing for human trials more quickly. The first volunteers were given trial injections in April.

Sarah Gilbert, the programme leader, first came across the new coronavirus in January. Her research group were already working on vaccines for diseases including Lassa fever, MERS and ‘disease X’, the name given to the unknown threat “that we knew was going to come and cause a pandemic at some time”. Given their available resources, she and colleagues decided to get started on a vaccine, just in case.

The Jenner Institute has its own manufacturing facility for Phase 1 and 2 clinical trials, and has previously conducted 12 clinical trials against similar diseases, giving Gilbert’s team a head-start. Organisation is key: the vaccine centre currently has around 200 people on rotas to manage the set-up of human trials, screening volunteers ready to take part as soon as vaccines are available.

“In the context of social distancing this is a huge logistical challenge,” notes Andrew Pollard, chief investigator on the study. To speed the process up, the team must effectively build the train while on the track: researchers would ordinarily wait more than a year after the first phase of trials has finished before moving on, “but here in a pandemic we have to manage things differently”.

Manufacturing the vaccine, adds institute director Adrian Hill, is “one of the biggest challenges faced. It’s no good telling you the vaccine works but we don’t have any ready.” As such, “risk manufacturing” of the most promising vaccine candidate has already begun.

“We’re now moving to a point where, instead of doing maybe three-litre manufacturing runs, we’re up to 50 litres. We’ll go to 200, maybe even 2,000 litres. The aim is to have at least a million doses by around September, once we’ve got the vaccine efficacy result, and then move even faster from there – it’s pretty clear the world is going to need hundreds of millions of doses by the end of this year.”

In fact, AstraZeneca signed a deal at the end of April with the Jenner Institute to team up to manufacture and distribute the prospective vaccine, with the capacity to supply up to 100 million doses by the end of the year, and then expand from there. Gilbert has given the project an 80 per cent chance of success, possibly as early as September.

Resilience and risk-taking come to the fore

Jenny Ottenhoff is a project leader for health and education programmes at the ONE campaign. A major part of her role is to drive routine and targeted fundraising on a global scale to support charity and research bodies.

“One of the challenging things about COVID-19 is that the objective is clear but how to get there is murkier than ever,” she says.

“Making decisions when you aren’t positive that you have the right information is challenging. So keeping a resilient attitude and making it clear to partners that you might be taking some risks is really key in this time of uncertainty.

“We’re drawing on expertise and resources, talking to every partner we can to share ideas, lock intel and try to connect dots. Right now, I think the biggest lesson from this outbreak is that we’re all in this together and the solidarity message is really key. It absolutely cannot be done in a silo.”

This global connectedness is an ambition shared by researchers in Gilbert’s lab, too. “We would be really keen to work with other vaccine developers, either sending them samples from our clinical trials or receiving samples from theirs so we can start to compare the immune responses.

“With the 2014 Ebola outbreak, this didn’t happen. Different groups were using different ways of measuring the immune responses so it wasn’t possible to compare like with like until after one of the vaccines had been through an efficacy study – when it should really be the other way round.”

The lessons to be learned for next time

“We are seeing significant positive movement: public-private partnerships, sharing of information across traditional boundaries, funding from government and philanthropic sources, vocal demand for vaccines,” Huuskonen reflects, “[and yet] from a programme management perspective there isn’t a clear global or national plan, nor a clear definition of roles and responsibilities. Still a siloed approach rules more than not – and, unfortunately, political and personal agendas get in the way.”

“I am very optimistic that we will learn from this and continue to improve the global response to these types of things. We already have,” Ottenhoff adds. “But it’s imperative that preparedness stays at the forefront of policymakers’ minds once this is over.”

Ultimately, project leaders need to be willing to make risk management a regular feature in their month-to-month planning, not just after a crisis has hit. “But I would say it really happens at a government level,” Ottenhoff concludes, “every country on earth needs to be prepared for an epidemic, and until all of us are prepared and our systems are functioning well, we’re all at risk.”

This article is an edited extract from a longer article that appears in the summer 2020 edition of APM’s quarterly Project journal, an exclusive benefit for APM members. Find out more about how you can access the journal at apm.org.uk/project/

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