Commissioner of the US Food and Drug Administration, Dr. Stephen M. Hahan testified before the House Committee on Energy and Commerce on the Trump Administration’s response to the COVID-19 epidemic on Capitol Hill in Washington, DC, June 23, 2020.
Kevin Dietush | Pool via Reuters
The Food and Drug Administration will authorize a coronavirus vaccine on Thursday, as long as it is safe and at least 50% effective, on Thursday, the agency’s Commissioner Dr. Stephen Hain said.
“We all want a vaccine tomorrow. It’s unrealistic. And we all want a vaccine that’s 100% effective. Again, unrealistic,” Hahn’s Dr. of the Journal of the American Medical Association. Said in an interview with Howard Boucher. “But we said 50%, and the reason was that we felt it was a proper floor that was given an epidemic.”
He stated that the minimum requirement of 50% effectiveness also helped guide vaccine manufacturers on designing their clinical trials. Modern and Pfizer, earlier this week sent their vaccine candidates in three stages, aiming to include about 30,000 participants to prove the vaccine is both safe and effective in a large population.
It is expected that Hahn said, the vaccine or vaccines that are being authorized will prove to be more than 50% effective, but it is possible that the US may end up with a vaccine that, on average, is a Cidid-19 person. Reduces the risk of infection by just 50%.
“We really felt strongly that the floor had to be there,” he said, adding that it “batted between medical groups.” “But for the most part, I think, infectious pathologists have agreed that this is a reasonable floor, certainly hoping that the actual effectiveness will be greater.”
Dr. Anthony Fauci states that he expects the vaccine’s efficacy rate to be at least 60%, meaning that on average the vaccine reduces a person’s risk of Kovid-19 infection by 60%.
On Monday, he said, “Obviously, we want to see this much, much higher. But 60% is the standard you make for the cutoff. It’s not uncommon.” “I’d like to see the highest percentage we could possibly get.”
Hahn said Thursday that if a vaccine is not safe, the FDA will not authorize it, regardless of how effective it is.
“If we reach 50%, but it’s not safe for me, it’s not the vaccine we can authorize,” he said. “We are going to look at those security data very, very, very carefully and be transparent about what we have seen, Howard.”
He said the FDA is using new strategies and technology to streamline data collection from clinical trial participants to collect data on safety more quickly and often. He added that the FDA will also continue to monitor the safety of vaccines, as they are authorized and administered to the public.
“We may not have a situation where people lose confidence in the FDA and the clinical trial process,” he said. “It would be a mistake for all of us.”