FDA says it would phase out coronavirus vaccine as long as it’s safe and at least 50% effective

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The Food and Drug Administration would allow a coronavirus vaccine as long as it is safe and at least 50% effective, agency commissioner Dr Stephen Hahn said Thursday.“We all want a vaccine tomorrow. It is unrealistic. And we all want a 100% effective vaccine. Again, unrealistic, ”Hahn said in an interview with Dr. Howard Bauchner of the Journal of the American Medical Association. “But we said 50%, and the reason was we felt it was a reasonable low given the pandemic. ”

He added that the minimum 50% efficacy requirement has also helped give vaccine manufacturers advice on how to design their clinical trials. Moderna and Pfizer sent their vaccine candidates to phase three trials earlier this week, aiming to recruit around 30,000 participants to prove that the vaccines are both safe and effective in a large population.

Hopefully, Hahn said, the vaccine or vaccines that end up being licensed will prove to be over 50 percent effective, but it’s possible the United States will end up with a vaccine that, on average, reduces the risk of a person with Covid-19. infection of only 50%.

“We really felt that it had to be speaking,” he said, adding that “it was beaten by the medical groups”. “But for the most part, I think, infectious disease experts have agreed that’s a reasonable low, of course hoping that the actual effectiveness will be higher. ”

Dr Anthony Fauci said he hopes the vaccine will have an effectiveness rate of at least 60%, which means that on average the vaccine lowers a person’s risk of Covid-19 infection. by 60%.

“Obviously we would like it to be much, much higher. But 60% is the standard you make for the threshold. It’s not unusual, ”he said on Monday. “I would like to see the highest percentage we could get. ”

Hahn added Thursday that if a vaccine is not safe, the FDA will not allow it, no matter how effective it is.

“If we get to 50% but it’s not sure, for me it’s not a vaccine we can authorize,” he said. “We’re going to be looking very, very, very carefully at this safety data and we’re going to be transparent, Howard, about what we’ve seen. ”

He said the FDA is using new strategies and technologies to streamline data collection from clinical trial participants to collect safety data more quickly and frequently. The FDA will also continue to monitor the safety of vaccines after they are cleared and given to the public, he said.

“We can’t have a situation where people lose faith in the FDA and the clinical trial process,” he said. “It would be a mistake for all of us. “

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