U.S. government scientists have begun attempts to develop a new coronavirus strain that could be used in human vaccine test experiments, a divisive method of study in which healthy people will be vaccinated and later intentionally contaminated with the virus, Reuters has reported.
The study is tentative and these experiments will not replace large-scale, Phase 3 studies such as those now under way in the United States evaluating Moderna Inc and Pfizer Inc. experimental COVID-19 vaccines, according to a statement sent by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to Reuters.
U.S. authorities coordinating the pandemic battle have come under scrutiny from activist organizations. Such as 1 Day Sooner and others who see challenge trials as a means to step up COVID-19 vaccine development. Most vaccine trials focus on inadvertent contamination, which can take time to develop.
Some drug makers, including AstraZeneca and Johnson & Johnson, have indicated they would consider developing coronavirus vaccines for human challenge trials if appropriate.
“If human challenge trials are necessary thoroughly test candidate vaccines or therapies. For SARS-CoV-2, NIAID has begun exploring the technological and ethical implications of performing human challenge trials”. Noted the agency announcement.
This involves efforts to develop an effective SARS-CoV-2 strain. Draft a clinical guideline, and determine the tools required to perform these tests.
Large challenge trials for handling coronavirus will be going in small isolation systems. Larger competition research with 100 or more participants in different places will have to be. Requiring months of planning to plan the tests.
These trials are also usually going where a virus does not spread extensively, which is not the case for COVID-19. Many scientists view the novel coronavirus’ human challenge experiments as immoral. Since there are no “rescue treatments” for those who become sick.
Johan Van Hoof, global vaccine manager for J&J, said in an interview with Reuters earlier this week that plans for these trials are underway globally, and also the organization is monitoring such plans.