The project will compress the typically required up to ten years of vaccine development and testing, within a few months, a testament to the urgency to tackle the pandemic, which has infected more than 5 million people and claimed the lives of more than 335,000 and battered economies worldwide.
To reach this stage, leading vaccine manufacturers have agreed to share data and their clinical trial networks with competitors if their own candidate fails, the researchers said.
Applicants who demonstrate safety in small early studies will be tested in huge trials of 20,000 to 30,000 people for each vaccine, to be launched in July.
Between 100,000 and 150,000 people can be included in the studies, said Dr. Larry Corey, a vaccine expert at the Fred Hutchinson Cancer Center in Seattle, who is helping to develop the studies. “If you don’t see a safety problem, just keep going,” Dr. Francis Collins, director of the National Institutes of Health (NIH), told Reuters. The vaccine effort is part of a public-private partnership called Accelerating Therapeutic Interventions and Vaccines for COVID-19 (ACTIV), announced last month.
The approach has its risks, as some safety issues can only occur in large-scale trials. Americans are concerned about the speed of vaccine efforts, according to a study by Reuters / Ipsos. The highly effective vaccine can only be tested for six months if there is a big difference in benefit between the vaccine and the placebo groups, Corey said. For a moderately effective vaccine, trials can take nine to 12 months.
The US government has set aside billions of dollars to help manufacturers produce hundreds of millions of doses of vaccines that may never be successful.
Translation and editing: Julian Markov
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