Researchers in the United Kingdom are taking a more extreme route in the study of a pontential coronavirus vaccine, with the government planing human challenge studies that are designed to purposefully infect healthy volunteers with the virus as a way to speed up vaccine development.
This type of study differs from the typical clinical trial because healthy, young participants will receive both the vaccine and the virus in a controlled setting rather than leave their exposure to the virus up to chance. These studies unsurprisingly raise ethical concerns, especially in the case of SARS-CoV-2 because there is so much unknown about the virus.
Yet, British researchers feel that the risks of a challenge study are justified, as the quicker scientists identify the most effective vaccines, the quicker the deadly pandemic can be brought under control.
"Deliberately infecting volunteers with a known pathogen is never undertaken lightly," said Peter Openshaw, co-investigator in the pontential study, quoted by the Associated Press. "However, such studies are enormously informative about a disease, even one so well studied as COVID-19."
Lead by the Imperial College, the proposed study will involve up to 90 healthy volunteers aged 18 to 30. The study will be conducted in partnership with the U.K. government's Department for Business, Energy and Industrials Strategy, the Royal Free London NHS Foundation Trust, as well as a company with experience is conducting challenge studies called hVIVO, which is a segment of the pharmaceutical company Open Orphan.
The U.K. intends to invest 33.6 million pounds ($43.4 million) towards the research, which is still waiting approval for independent ethics committees and health regulators. The study is expected to begin in January 2021 and produce results by May of the same year.
The study's timeline will likely concluded after one or more coronavirus vaccines are approved for public use. A few vaccine frontrunners like Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA) have stated that their trials will produce enough data this year to submit for an emergency use authorization from at least the U.S. Food and Drug Administration by the end of this year.
Despite potential vaccine approvals ahead of the study's results, the information that could come from the study will be important due to the likelihood that many populations will have to wait longer for a vaccine. The study can show quickly which vaccines are more effective, thus streamlining production away from other less effective candidates.
On Monday, the number of confirmed COVID-19 cases globally surpassed 40 million, with that total unable to quantify the true impact of the pandemic has on the population of the world. Currently, cases have begun to accelerate in parts of Europe, prompting government officials to issue renewed social restrictions and lockdowns. The U.S. is also starting to see the beginnings of a surge, with cases and hospitalizations raising in most states.