Top health officials faced tough questions on Capitol Hill about a vaccine for the coronavirus and the need for transparency in the process. (June 30)
ANTHONY FAUCI: There is no guarantee, and anyone who's been involved in vaccinology will tell you, that we will have a safe and effective vaccine. But we are cautiously optimistic, looking at animal data and the early preliminary data, that we will at least know the extent of efficacy sometime in the winter and early part of next year.
BOB CASEY: --very high rates of vaccine refusal as well as skepticism. What role can the FDA play in the coming months to earn the public's trust that COVID-19 vaccines are safe and effective? That's question number one, what role the FDA can play. And then the second question is, what steps can you take as FDA Commissioner to bolster public confidence?
STEPHEN HAHN: We have an obligation to use all of our scientific knowledge, our regulatory framework, to ensure that any vaccine that comes before us, whether for authorization or approval, meets our stringent standards for safety and effectiveness.
So we are providing technical assistance to those sponsors, but we are not part of the decision-making process, and we will maintain our regulatory independence. I will not prejudge. The agency will not prejudge any decision with respect to this. But we will use the science in the data.
Senator, I commit to you that I will continue to be a voice emphasizing the regulatory independence. We have a number of communications in progress to communicate to the American people that the standards we're going to uphold are firm, they are rooted in science and data, and that they will ensure that we meet the usual high standards of FDA with respect to safety and efficacy.
PATTY MURRAY: I'm as eager as anyone for a vaccine. But this isn't just about doing something fast. It is about doing it right. That's why we need to know the process for developing a vaccine is rigorous, it's inclusive, it's transparent, and it is science-driven.
But in light of the hydroxychloroquine debacle and the removal of Dr. Bright from BARDA for questioning the administration's efforts to promote that unproven treatment, we cannot take for granted this process will be free of political influence. We have to demand serious oversight.