Researchers outline the need for a new approach to COVID-19 vaccine testing
At Rutgers University top researchers are calling for a change in approach to the development of COVID-19 vaccines and vaccines to combat future pandemics to include both conventional and challenging trials.
Comments on bioethics Nir Eyal and epidemiologists Tobias Gerhard and Brian Strom (the latter is Chancellor of Rutgers Biomedical and Health Sciences) – published in Pharmacoepidemiology and Drug Safety – explores how this parallel approach in vaccine trials could lead to faster and more accurate vaccine evaluation and a more effective pandemic response.
In traditional randomized controlled trials, participants receive a vaccine or placebo and may or may not be exposed as they continue to live for the following months.
In human exposure vaccine trials, participants receive a vaccine or placebo and are then artificially exposed to the virus.
Researchers say additional vaccine testing could help address the remaining questions about how effective vaccines prevent infection against old and new strains of the virus.
It could also reveal the most effective dosing and timing between injections, the level of protection compared to innate immunity, and how well the vaccines performed in groups that were underrepresented in the original experiments.
At the beginning of the COVID-19 pandemic, some researchers suggested that challenge tests be conducted, while others argued that too little was known about the virus and that testing would be too dangerous.
They were not used in the studies that led to the approval of the main COVID-19 vaccines, but are now being used in testing.
“Unfortunately, the heated debates over the design of vaccine trials in the early months of the COVID-19 pandemic were mostly the opposite debate between proponents of challenging research and proponents of conventional trials. We felt that the third approach was overlooked. for the remainder of the time and future pandemics, “says Gerhard, director, Rutgers Institute for Health, Institute for Pharmacoepidemiology and Nursing Research. IFH) and Professor Rutgers Ernest Marion from the School of Pharmacy.
A parallel approach by Rutgers researchers, called “Combining Conventional and Challenge Studies (CCC),” would involve both types of experiments either simultaneously or at different times.
“Acquiring information at the earliest possible stage in a pandemic is of such great value that‘ CCC ’is ethically superior to any single study, and preparing for a future pandemic should include laying the groundwork for CCC,” said Eyal, Henry. Rutgers Professor of Bioethics and Director of Rutgers IFH Center for Population Bioethics.
Eyal and colleagues say researchers will be able to gather more information and increase confidence in the effectiveness of vaccines.
“When either human exposure or routine testing is permitted, it may still be advisable to combine routine and challenge testing to provide certainty, faster and more comprehensive vaccine evaluation, and a more complete understanding of infection and disease,” Gerhard said.
They said two experiments instead of one would save resources, answer more questions, and increase the chance that at least one experiment would succeed.
“The added value of faster and more informative testing of a key weapon against a pandemic that threatens an exceptional number of people worldwide is generally very high,” Strom said.
Source: ANI