BALTIMORE (WJZ) — Efficacy “readouts” of two clinical trials for COVID-19 vaccines are expected “November or December,” according to Operation Warp Speed Chief Advisor Dr. Moncef Slaoui.
“Our mission is to deliver an approved vaccine to the American people before the end of the year,” Dr. Slaoui told an online symposium Tuesday. “The first wave, with RNA vaccines, immediately–November, December.”
The symposium, hosted by Johns Hopkins University and the University of Washington, focused on the integrity, development, and allocation of COVID-19 vaccines.
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“We’ll need to see data from a large, well-designed, Phase 3 clinical trial that shows clear and compelling evidence of effectiveness of that vaccine. And, that’s what’s going to get these vaccines over the hump,” Dr. Peter Marks of the Food and Drug Administration said. “Because we at FDA feel comfortable giving that vaccine to our families, they’ll feel comfortable giving it to their families.”
“This is an alarming erosion of trust,” Johns Hopkins University President Ronald Daniels said in introducing the panelists. “We know that science done right is as important as science done quickly.”
The FDA released guidance Tuesday on Emergency Use Authorization with a focus on quality, safety, and efficacy.
Once a vaccine or vaccines are approved, Dr. Slaoui said the challenge will be scaling up. He said he hopes for full immunization by the end of 2021.
“Producing millions or tens or hundreds of millions doses of vaccine where you make sure the first dose and the 100 or 500 millionth dose of vaccine is the same—consistently the same—is a very different story,” Dr. Slaoui said.
Dr. Slaoui pledged to resign his position if there is political interference with vaccine development.