Healthy volunteers to be injected with Covid-19 in vaccine trial
Oct 21 2020
The first trials to deliberately infect people with the coronavirus to accelerate the development of vaccines could occur in the United Kingdom next year as part of an agreement reached by the government.
If approved by regulators and an ethics committee, the studies will start in January with results expected by May 2021, the government said.
For the current COVID-19 vaccine candidates that are in Phase 3 - the final stage of testing - tens of thousands of volunteers are given an experimental vaccine and then released to live their everyday lives; researchers assume that a certain percentage of them will be exposed to the virus naturally.
The agreement may mark a turning point in the debate over whether to conduct such studies, which could help researchers in their bid to combat the virus but expose healthy volunteers to potential risks.
The Imperial College lead researcher on the project, Dr. Chris Chiu, insists the safety of the volunteers is the number one priority. "No study is completely risk free, but the Human Challenge Programme partners will be working hard to ensure we make the risks as low as we possibly can".
"First, for the many vaccines still in the mid-stages of development, human challenge studies may help pick out the most promising ones to take forward into larger Phase 3 trials", he said.
Unlike the human adenoviral vector used in the US' Johnson & Johnson, China's CanSino and Russia's Sputnik V vaccines, the scientists note that AstraZeneca's monkey adenovirus-based vaccine had not been studied over a long period of time. "My team has been safely running human challenge studies with other respiratory viruses for over 10 years".
The UK Government has today announced a cross government, academia and private sector partnership "to explore and establish" human challenge trials for COVID-19.
Up to 90 volunteers could be involved at the early stage, it said. The rate of severe COVID-19 in healthy people aged 18 to 30 is low, but it is plausible that a volunteer will react badly to being infected with SARS-CoV-2.
The model will be developed by Open Orphan's subsidiary hVIVO and will involve the manufacture of the challenge virus which help researchers determine the optimum dose for use in future human challenge studies.
It was earlier pointed out by Russian researchers that anti-COVID-19 vaccines developed by some of their global colleagues and made using mRNA and monkey adenoviral vector-based platforms rely on "novel, unproven technologies".
England's Deputy Chief Medical Officer Professor Jonathan Van-Tam said a safe, fully approved, and meticulously controlled human challenge model for COVID-19 may help in the search for safe and effective vaccines.
The agency said it anticipates delivering over one billion syringes to support COVID-19 vaccination efforts on top of the 620 million syringes that it will purchase for other vaccination programs against other diseases such as measles and typhoid. The study is being sponsored by Imperial College London and will be conducted at The Royal Free Hospital's specialist research unit in London.
Biotech companies and academic bodies around the world have joined forces to try to create a vaccine against the coronavirus at breakneck speed given its ferocity.
A non-profit group called 1Day Sooner has already attracted more than 38,500 volunteers in more than 165 countries to take part in such studies.