Healthy volunteers should purposely be infected with the coronavirus to speed up the race for a vaccine, leading researchers say.
The trio of scientists argued relaxing current rules could ‘accelerate’ the roll-out of a jab to protect the world against COVID-19.
In a stark warning, they said every week a vaccine is delayed it will be ‘accompanied by many thousands of deaths globally’.
Figures show almost 500,000 people have now caught the life-threatening infection since the outbreak began in Wuhan, China, in December.
The death toll stands at more than 21,000 – a figure that has almost doubled outside of China since Monday as Europe’s crisis continues to spiral.
The World Health Organisation (WHO) have said it could be a year before a COVID-19 vaccine is available because it must safe.
One of the co-authors of the paper, from the London School of Hygiene and Tropical Medicine, said their unique approach could ‘shave months’ off vaccine development.
Dr Peter Smith told The Times: ‘I think regulators will be open to it.’
But he admitted convincing ethics boards, who evaluate things such as the burden of disease compared to the risks of a new vaccine, could prove more difficult.
The other two academics behind the suggestion came from Harvard University and Rutgers University in New York, respectively.
In their paper, the trio wrote: ‘Deliberate exposure of study participants to SARS-CoV-2 clearly raises ethical concerns.
‘It may seem impermissible to ask people to take on-risk of severe illness or death, even for an important collective gain.
‘But we actually ask people to take such risks for others’ direct gain every time we ask volunteer firefighters to rush into burning buildings.’
The call for a ‘challenge trial’ – as it is known – goes against standard procedures.
Drugs and vaccines tend to be tested in three stages before they get approved for human use.
The first phase is a safety run, giving a small number of people a dose and seeing how their body reacts.
Phase two trials involve more people, and scientists will work out the correct dosage. They will also test the vaccine against a placebo.
And phase three – the final stage of testing – is the real deal. It involves hundreds, sometimes thousands, of people across multiple sites for a long period of time.
Development of a vaccine is a lengthy process with lots of hurdles to minimise risks to patients.
But the senior scientists, including Harvard’s Professor Marc Lipsitch, suggest bypassing phase three to speed up the process.
Instead they urge rolling all phases into a controlled study they believe has the potential to ‘cut the wait time for the rollout of an efficacious vaccine’.
It would involve 3,000 or so people, assessing only the short-term effects of the vaccine. While it goes through licensing, the long-term effects could be monitored.
It would mean regulators and ethics boards to loosening their criteria, which would be a challenge considering the risk to people.
‘Deliberate exposure of study participants to SARS-CoV-2clearly raises ethical concerns,’ the academics write.
‘It may seem impermissible toask people to take onrisk of severe illness or death, even for an important collective gain.
‘But we actually ask people to take such risks for others’ direct gain every time we ask volunteer firefighters to rush into burning buildings; relatives to donate a live organ to loved ones; healthy volunteers to participate in drug and vaccine toxicity trials with no prospect of improving their health.’
Using young, health volunteers in the initial stages of the trial provides a safety net, the team argue.
All the current data suggests that while COVID-19 can be unpleasant for younger people, the eventuality of death is very unlikely.
This does not mean risk is entirely removed though, because vaccines can have the opposite effect to the one intended.
Normally a ‘challenge trial’ like this would be considered only if there was a cure for the disease.
The team say that volunteers would be monitored very closely and should anything happen, they would receive ‘excellent care’ in ‘state of the art’ facilities.
Volunteers would also be deeply informed about the risks so that they can make a decision about going forward.
WHO says there are 45 vaccines in development, two of which have reached phase one clinical trials.
It takes years to develop new treatments for illnesses because new medicines must be extensively researched.
Even if they prove successful, they must be produced on a large scale, which needs billions of dollars, and be vetted by regulators.
Because vaccines for COVID-19 are still in the making across the world, it is unlikely any will be finished in time to halt the current pandemic, which is being controlled with social behaviour methods instead.