Scientific efforts to develop a Covid-19 vaccine will depend on tens of thousands of volunteers in a giant scientific, medical and logistic company. The goal is to “provide significant amounts of a safe and effective vaccine by January 2021,” said Alex Azar, secretary for health and human services, in a statement.
Testing a vaccine is a conceptually simple idea, but it’s a careful and methodical process that evolves through a gradual system of studies that get bigger and bigger. Early clinical trials, some of which showed encouraging results, assess the correct dose of the vaccine and monitor safety concerns in dozens or hundreds of patients. However, the ultimate test of these vaccines will be large studies designed to test whether they can effectively prevent or reduce the severity of the disease.
The first late-stage vaccine trial, in which 30,000 people will randomly receive either an experimental vaccine from the biotechnology company Moderna or a placebo, is expected to start in the second half of July. It is expected that at least five such large-scale vaccine trials will be conducted over the network in the coming months ̵
“This is what we do for a living and what we do for a living,” said Larry Corey, virologist and former president of the Fred Hutchinson Cancer Center, who oversees the study network. “We have significant infrastructure, probably the country’s largest vaccine infrastructure.”
Starting experiments of this magnitude in such a short time requires tremendous coordination to ensure that the data is consistent across many different locations.
The Moderna study observed 30,000 volunteers for two years and asked to keep a diary with symptoms and to be available for weekly check-in phone calls, said Richard Novak, head of the Infectious Diseases Department at the University of Illinois at Chicago College of Medicine. He said he would recruit 1,000 volunteers for this study.
“It’s really an intense effort,” said Novak. The infrastructure required ranges from devices that are checked regularly to show that freezers never fail, from employees who check potential participants to setting up a call center to allow thousands of check-ins, to building bridges to the community to ensure that different groups of people, especially those at greatest risk for Covid-19, sign in.
“Putting this into operation is a 24/7 job,” said Novak.