Sanofi and GlaxoSmithKline said they are starting a human trial of their COVID-19 vaccine in the U.S. The trial will involve 440 healthy adults, with the drugmakers expecting preliminary results in early December.
GlaxoSmithKline, the world’s largest vaccine maker, and France’s Sanofi have a $2.1 billion deal with the U.S. government to develop and manufacture a coronavirus vaccine. That deal is part of Operation Warp Speed, the effort to develop multiple COVID-19 vaccines simultaneously.
The Trump administration has set a goal of delivering 300 million doses of a virus vaccine by January. Sanofi and GSK said they expect to start a Phase 3 trial with a larger number of people in December. Three Phase 3 vaccine trials are currently underway out of six the vaccine candidates backed by Operation Warp Speed.
Sanofi and GSK said they plan to request regulatory approval for their vaccine in the first half of 2021, if the data are positive and warrant moving forward.
Doctor discusses latest on COVID vaccine
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It typically takes 10 years to develop a vaccine and roll it out on a massive scale, according to Deutsche Bank analysts. But once a vaccine makes it to a Phase 3 trial, it has an 85% chance of receiving approval, they noted in a report.
“The emergency nature of the situation has led to a shortened testing timeline,” the analysts noted. “All candidates have received regulatory approvals to move quickly to human trials, skipping years of animal trials that are normally required.”
Because of the number of companies developing vaccines and the accelerated timeline, there should be “significant developments by November,” they added.