World’s biggest coronavirus vaccine trial gets underway in US

The world’s biggest COVID-19 vaccine trial got underway in the United States on July 27 with first of the 30,000 expected adult volunteers who have not been infected by the virus. The Phase 3 clinical trial has been designed to evaluate when a vaccine candidate can be effective in preventing symptomatic coronavirus infection in adults.

Several other countries including China and Britain have already started Phase III trial for their vaccine candidates but the scale of trial isn’t as large as for mRNA-1273. The potential coronavirus vaccine has been co-developed by the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID). 

US’ top infectious disease expert Dr Anthony Fauci said in a statement that the results from early-stage clinical testing indicate that mRNA-1273 vaccine candidate is safe and immunogenic, supporting the initiation of Phase 3 clinical trial. Dr Fauci, also the director of NIAID, said that the scientifically rigorous, randomised, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last.

“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate SARS-CoV-2 spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic,” he added.

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Blind trial

The vaccine trial will be blinded, preventing investigators and the participants from knowing who is assigned in which group. The participants will be randomly assigned 1:1 to receive either two 100 micrograms (mcg) injections of mRNA-1273 or two shots of a saline placebo, approximately 28 days apart.

According to the National Institutes of Health, the trial also aims to study whether the vaccine can prevent severe COVID-19 or laboratory-confirmed SARS-CoV-2 infection with or without disease symptoms. It also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19, among other objectives.

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