For months, vaccinologist Sarah Gilbert has been in a race against time, working seven days a week to develop a vaccine for the coronavirus that causes the potentially lethal disease Covid-19.
Gilbert and her fellow researchers at Oxford University face a myriad of technical challenges and potential complications in their quest to defeat the virus that has claimed 100,000 lives and crippled economies worldwide.
Yet, one far more mundane obstacle overshadows them all: money.
Gilbert, a professor at Oxford’s Jenner Institute & Nuffield Department of Clinical Medicine, estimates her team needs up to £100 million (US$123 million) by June to succeed in their goal of developing a proven vaccine and partnering with a drug maker to manufacture it on a mass scale by autumn – a time frame up to a year shorter than those set by major pharmaceutical companies such as GlaxoSmithKline.
According to the World Health Organisation, more than 60 separate teams in about a dozen countries are involved in the global sprint to develop a coronavirus vaccine, comprising major pharmaceutical companies, biotech start-ups, government-run institutes and universities ranging from the University of Queensland to Johnson & Johnson and the Chinese Centre for Disease Control and Prevention.
Gilbert said she believed her team has made the most progress so far and is likely to be first to reach the crucial milestone of showing vaccine efficacy.
Despite this, she is only “optimistic, but not confident” the money she needs will arrive in time – or even at all.
“I don’t think the people with the money have really quite adjusted yet to what the vaccine developers need,” said Gilbert, who kick-started work on a coronavirus vaccine with a sum of about £500,000.
The funds were provided by the British government-funded Engineering and Physical Sciences Research Council and originally intended for other vaccines.
“I think in the minds of governments and the layperson, that’s for later. Because there’s such a demand for ventilators and personal protective equipment, that’s all anybody can think about now.” Gilbert said.
In recent weeks, Gilbert, who previously has worked on vaccines for Mers, the Nipah virus and Lassa fever, has spent countless hours filling out grant applications, searching for new funding partners and seeking approval to repurpose research funding earmarked for other uses – time she would have rather spent at the lab utilising her scientific expertise.
“A lot of academic funding these days is very, very constrained in what it can be spent on,” said Gilbert, whose work so far has been supported by university funds and government grants.
“There’s a very precise and detailed plan. That’s fine if the plan is what’s required. But when you need a new plan, when something else has happened, you need the flexible funding to be able to respond to that,” she said.
The financial and bureaucratic hurdles facing the Oxford team indicate a mismatch between resources and incentives at the heart of vaccine development that could complicate the global effort to resolve a crisis that has focused the world’s attention like few problems in living memory.
Put simply, pharmaceutical companies that possess the means to fund expensive new vaccines often lack the motivation, seeing greater returns in treatments for chronic conditions such as diabetes and high cholesterol.
On the flip side, universities, publicly funded institutes and biotech start-ups that have the inclination and ability to step into the gap often lack the means.
The sheer scale of the crisis wrought by Covid-19 has spurred major firms to get involved, but belatedly and only with heavy state backing.
Pharmaceutical giants Johnson & Johnson and French multinational Sanofi are both relying on taxpayer-funded work by the Biomedical Advanced Research and Development Authority, a division of the US Department of Health and Human Services, to underpin their work on a vaccine.
“Until this model is fixed at the economic level, development of infectious disease treatments and vaccines will continue to face uphill battles,” said Ooi Eng Oong, deputy director of the Emerging Infectious Diseases Programme at the Duke-NUS Medical School in Singapore.
TOO COSTLY, TOO RISKY
Vaccine development is extremely costly and, from a business perspective, risky work.
Once a potential vaccine is created in a lab, it must go through three stages of clinical trials involving human subjects, culminating in Phase III trials during which a target population is administered the vaccine to test its effectiveness.
Multinational pharmaceutical companies such as Pfizer, GSK and Johnson & Johnson claim to spend between US$1 billion and US$2 billion to take a vaccine from the lab to its roll-out among the general population, a process typically taking 5 to 10 years and sometimes longer.
Michael Kinch, director of the Centre for Research Innovation in Biotechnology and Drug Discovery at Washington University in St Louis, said the major drug companies generally viewed vaccine development as high in risk and low in reward.
“The technology for most vaccines is not as advanced as for other more sexy technologies that can garner higher prices and thus revenues,” Kinch said.
Balking at the cost of in-house research, major drug companies have slashed R&D budgets in recent years to focus on the late-stage development and manufacturing of treatments pioneered externally – often by publicly funded entities such as government institutes and universities.
All 210 new drugs approved by the US Food and Drug Administration between 2010 and 2016 were developed with funding from the National Institutes of Health, which distributes about 80 per cent of its US$40 billion annual spend on medical research to more than 2,500 universities and research institutes worldwide.
Given the reliance of industry on publicly funded research, resource issues at the university or research-institute level have the potential to dramatically affect the range of treatments that ultimately come online.
“Big Pharma generally do not have research divisions anymore, they gave those away when they found their research was three times as expensive per drug developed than ones sourced from academia,” said Ian Frazer, a professor at the University of Queensland who co-invented the human papillomavirus vaccine. “Industry only gets involved in manufacturing and marketing a likely successful product.”