Moderna's COVID-19 vaccine goes into final human trial stage
In a major development, the COVID-19 vaccine developed by biotech giant Moderna Therapeutics has gone into the third and final stage of clinical human trials. The late-stage study, first one to have started by the United States, is the last step before the vaccine candidate is lined up for regulatory review and emergency-use approvals. Here are the details of the trial.
As part of the Phase-3 trial, Moderna is administering its experimental shot, dubbed mRNA-1273, on as many as 30,000 volunteers - people who are healthy and have not been infected by the novel coronavirus disease. The trial is set across 89 US sites, including the Washington DC and some worst-hit regions like Texas, California, Florida, Georgia, Arizona, and North and South Carolina.
The study, as explained by Moderna, is a randomized, observer-blind, placebo-controlled trial to evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years. Under this, a select group of participants will get two 100 microgram shots of the vaccine in a gap of 28 days, while the others, a control group, will get a placebo for comparison.
Once the participants are injected, they will be allowed to go about their daily routines and monitored/tested to see how effectively and safely the shot works on them. The main goal of the study is to see if the vaccine could prevent COVID-19 symptoms after two doses, while the secondary objectives include whether it could prevent severe COVID-19 case or death caused by it.
The Moderna vaccine, developed jointly by Moderna and US NIAID, has seen some delays to go into the final trials, but the results from early-stage tests have shown promise. In the Phase-1, the shot was tested on 45 healthy volunteers and was able to generate an immune response against the virus in all the cases, without any major side effects.
"Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic," said Dr. Anthony Fauci, NIAID's Director. "This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last."
If all goes according to the plan and the vaccine achieves the primary and secondary objectives, the data generated from the late-stage trial will be submitted to the Food and Drug Administration (FDA) for review. After that, the authority should issue emergency use authorization for the vaccine, possibly making it available for public use by early 2021.
