The COVID-19 Prevention Trials Network, which knits together existing federal clinical trial infrastructure developed largely to test HIV vaccines and treatments, launched with a website for volunteers to join the roster of people to be considered when the first trials begin this month.
The scientific effort to develop a COVID-19 vaccine will depend crucially on tens of thousands of volunteers, in a gargantuan scientific, medical and logistical undertaking, with the aim of providing “substantial quantities of a safe, effective vaccine by January 2021,” Health and Human Services Secretary Alex Azar said in a statement.
Testing a vaccine is a conceptually simple idea, but it is a careful and methodical process that unfolds through a phased system of trials that grow progressively larger. Early clinical trials, some of which have reported encouraging results, assess the right dose of the vaccine and monitor for any safety concerns in dozens or a few hundred patients. But the ultimate test of these vaccines will be large trials designed to test whether they are effective at preventing or reducing the severity of disease.
The first late-stage vaccine trial, in which 30,000 people will be randomly assigned to receive either an experimental vaccine made by the biotechnology company Moderna or a placebo, is expected to begin in the second half of July. There are expected to be at least five such large vaccine trials conducted through the network over the coming months – as well as trials of other preventive measures, such as monoclonal antibody drugs.
“This is what we do for a living and have done for a living,” said Larry Corey, a virologist and past president of the Fred Hutchinson Cancer Center, who is co-leading the trial network.
Covid-19 is currently spreading out of control through the U.S. following the easing of social distance restrictions. On Wednesday, the country hit a grim milestone, passing 3 million cases nationwide. The White House’s “Operation Warp Speed” program hopes to simultaneously confirm a vaccine’s efficacy while preparing millions of doses. On Tuesday, the federal government awarded a $1.6 billion contract to the company Novavax to test and manufacture 100 million doses of its potential vaccine by January 2021.
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