'12 to 18 months would be a record'
Dr. Sonia Macieiewski and Dr. Nita Patel, Director of Antibody discovery and Vaccine development, look at a sample of a respiratory virus at Novavax labs in Rockville, Maryland. Photo: Andrew Caballero-Reynolds/AFP via Getty Images We’re committed to keeping our readers informed.
This was a study of about 125 patients with COVID-19. Of those, 113 had severe disease and they were treated with daily infusions of remdesivir. The point is, most of those patients have been discharged and only two of the patients died. That’s a fairly low mortality rate for 113 patients. The problem is, this is not a published study. We don’t have a lot of information about what actually happened from these results.
What kind of timeline are we looking at for a treatment like that? Can we look for something in the fall? We’re making a vaccine and we’re working late into the night and up early in the morning trying to move this vaccine into clinical trials, trying to meet Dr. Fauci’s aspirational goal. We’re going to do our best but it really depends on how things progress in terms of evidence of safety and also efficacy.
Our vaccine could be ready by the fall as well. We’ll have up to 200,000 doses. But unless you’ve shown that it actually works and unless you’ve shown that it’s safe, you’re not going to do that. Without having the efficacy and safety data, I think you have to be really careful about bold statements like that.
So there’s nothing that the FDA has done to the process that significantly changes the safety standards of these trials.
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