In a new development, it was announced by the United Kingdom government that the country will invest £33.6 million ($43.6 million) to provide funding for the first stage of Covid-19 human challenge trials.
~ @hVIVO to develop COVID-19 (SARS-CoV-2) human challenge study
~ Contract worth initial £10m
~ 3x trial challenge studies in 2021 worth up to £30m#raredisease #virology #covidtesting #covidchallenge https://t.co/DVG4SgcPjw pic.twitter.com/fT7wEHWnPg
— Novus Comms (@NovusComms) October 20, 2020
The Human Challenge Programme will be conducted by Imperial College London, which said Tuesday in a statement that it would be working in cooperation with the Department for Business, Energy and Industrial Strategy, the Royal Free London NHS Foundation Trust, and a clinical company that has worked on viral human challenge models.
UK researchers are set to explore a human challenge study with the virus that causes #COVID19.
— Imperial College (@imperialcollege) October 20, 2020
In these challenge trials, human subjects that would be given the coronavirus vaccine will then be exposed to the real live virus. This will help the scientist gauge the efficacy of the vaccine under development.
It is important to note, there have been many studies in which that has been done before. But all of them have been animal trials. These will be the first human trials that will check for a COVID-19 vaccine in subjects that will be later exposed to the virus.
The process of these trials will start after the researchers will develop a virus strain that can be used in the study. They will also have to figure out the smallest possible dose that can infect a human being before they expose healthy people to it. All the volunteers in the trial will be between the ages of 18 and 30 years old.
Before these trials can be initiated, the scientists will also have to gain regulatory and ethical approvals. Experts estimate that these challenge trials will be conducted between January and March next year. The trials will be conducted by hVIVO, a unit of pharmaceutical services group Open Orphan.
One of the non-profit organizations that support these challenge trials called, 1DaySooner, has praised the decision of the UK government.
Our statement on today's announcement of COVID-19 human challenge trials in the UK: pic.twitter.com/o8rpThtQWf
— 1Day Sooner (@1daysooner) October 20, 2020
“Every day without universal vaccination costs countless lives, so these studies need to begin as soon as a challenge strain is ready”, the organization explained. They added that they appreciate the altruism of thousands of people who have already signed up for the trials.
1DaySooner also shared that till date 38,659 people have signed up to be part of the COVID-19 Challenge trials. These people are among the residents of 166 countries in the world.
In normal human vaccine trials, the scientists rely on the subjects getting exposed to a pathogen naturally in their environment. The researchers wait for and rely upon regular testing of the subjects to see if there is a difference between the number of infections in the vaccinated and placebo groups.
However, this is where the approach differs in a challenge trial. In such studies, the scientists do not wait for natural exposure but themselves expose the subjects to the pathogen against which a vaccine is being developed. These trials have also proven to be effective in telling if the vaccines work or not.
The method was first used in the 18th century when British physician Edward Jenner used the method to develop the first-ever vaccine. that vaccine was developed against smallpox. That was not the only time this method was used. The scientists have used challenge trials to develop vaccines for typhoid, cholera and malaria.
Right now, the US National Institute of Allergy and Infectious Diseases (NIAID) is also trying to create a strain of coronavirus that can be easily used in these challenge trials. But, the top infectious disease expert in the country, Dr. Anthony Fauci has previously said that it would be “Plan D’ to resort to COVID-19 human Challenge trials.
Experts have also questioned the ages of the people involved in these trials. As the trial is recruiting young people who are unlikely to get exposed to or suffer from serious coronavirus infection, they studies might not reveal much on the subject of effectiveness of these trials.
Many have questioned if these vaccines could then be administered to older people who have co-morbidities. These are the people who are most likely to suffer from negative consequences of the disease.
Even Dr. Fauci, the head of one of the most prestigious government health agencies has questioned the functionality of these trials.
“You generally do [human challenge trials] if you don’t have enough infections in the community at any given time to get a signal from the vaccine,” Fauci said. “Unfortunately for us, we don’t have that problem — we have a lot of infections.”