Washington: Phase 3 clinical trials for the much-anticipated Oxford COVID-19 vaccine have begun in the United States this week, with participants in Madison, Wisconsin rolling up their sleeves for the injection.
The University of Wisconsin is one of dozens of test sites in the U.S. for the vaccine candidate, made by AstraZeneca in partnership with the U.K.’s University of Oxford. This will mark the start of the third phase 3 trial in the U.S. for a Covid-19 vaccine, following Moderna and Pfizer.
The beginning of the trial comes as President Donald Trump is exerting pressure to fast-track research on a vaccine, alluding to some sort of approval before the election in early November.
But Dr. William Hartman, an assistant professor of anesthesiology at UW Health and the University of Wisconsin-Madison School of Medicine and Public Health, doesn’t expect preliminary data until at least Thanksgiving.
“Our obligation is to make sure that in the end, we have a safe and effective vaccine,” said Hartman, who is the principal investigator for the UW trial.
“It takes at least a month to generate the antibodies that we’re looking to measure,” Hartman said. “At that point, a second injection is given.”
Participants must be followed for at least a month after that second shot to measure their levels of antibodies against the coronavirus. With that timeframe in mind, it would be around Thanksgiving before the company has at least preliminary data, Hartman said.
Researchers will follow the study participants for two years to determine how well the shots work, and how long such protection might last. But they’re likely to have a good indication of whether the vaccine is effective enough to warrant emergency use authorization.
The Food and Drug Administration has said an effective vaccine only needs to protect 50 percent of people to be considered effective.