Opening remarks by FDA Commissioner Stephen M. Hahn, M.D., as delivered.

Good morning Chairman Alexander, Ranking Member Murray, and members of the committee. Over the past several months, I’ve had the honor to work shoulder to shoulder with FDA’s career staff as we fought a historic pandemic that has altered the lives of every American. I am proud of all FDA employees and how they have measured up to this extraordinary challenge. The efforts of the FDA’s expert workforce are critical to ensuring the safety and health of the American public at any time, but it is magnified during a public health emergency. Of course, our work on COVID-19 and non-COVID issues, comes with unprecedented public scrutiny and sometimes criticism. Any agency that has the broad responsibilities and far reaching impact of FDA particularly involving issues of public health, can’t expect to do its job without inviting controversy and disagreement.

But it’s also essential that the criticism we get never shakes the underlying faith the public has and should have in FDA and our commitment to protecting the public health. I am confident in the decisions that are being made related to COVID-19, and that will be made in the coming months as we continue to address the challenges of this pandemic.

Now I know there’s been particular attention paid to a few of the decisions reached by FDA over the past several months. I want to assure you and emphasize that every one of the decisions we have reached has been made by career FDA scientists, based on science and data, not politics.

FDA represents science in action. Often we must make real time decisions based on ever evolving data concerning a previously unknown highly contagious virus that we are still learning about. And sometimes it is necessary to reverse decisions as new data emerge. This is inherent in the Emergency Use Authorization process, otherwise known as EUA, and it is akin to how a doctor might approach a patient in an emergency situation. Constantly updating a treatment plan as new data emerge.

So, in the interest of transparency, I’d like to use this opportunity today to lay out the process we will use to review vaccines for COVID-19. When a vaccine sponsor reaches the conclusion that the data from its phase three clinical trials are adequate to submit to FDA, they will decide whether to apply for approval or Emergency Use Authorization. This will be based upon the trial meeting pre specified success criteria that were established by that sponsor.

Now this is really important, they should also be consistent with FDA recommendations regarding those criteria. FDA will receive that application, or submission, and our career scientists will review it, safety and efficacy data, as well as manufacturing quality and consistency data. FDA made clear recommendations in our June 30 guidance regarding the safety and effectiveness of vaccines so that we can see that prior to the approval process.

We will also work to provide additional information so that it is clear what we expect to see, should a sponsor choose to submit an Emergency Use Authorization application. As we’ve indicated previously, we plan on seeking advice from the Vaccines and Related Biologics Products Advisory Committee comprised of independent members who have been screened for ethics conflicts. The safety and effectiveness data and the committee’s decision will be public, although we will need to adhere to confidentiality requirements. The public will have an opportunity to comment. The process will be transparent and independent. FDA career staff will then take the committee input into account as they make their decisions regarding the application, or EUA request. Now before we were to issue and EUA, if that were to happen, FDA would have to determine among other things that the statutory standard is met. We expect that this would be demonstrated based on adequate manufacturing data to ensure a vaccine’s quality, and consistency, and data from at least one well-designed phase three clinical trial that demonstrates its safety and efficacy in a clear, and compelling manner. Let me emphasize that again; data from at least one well-designed phase three clinical trial, that demonstrates its safety and efficacy in a clear and compelling manner.

FDA also expects that an EUA request would include a plan for active follow up to monitor safety among individuals who receive the vaccine. In the end, FDA will not authorize, or approve, a vaccine that we would not feel comfortable giving to our families.

On behalf of the 17,000 plus employees of the FDA, I want to make the following commitments today to the American public and this committee: FDA will not authorize or approve any COVID-19 vaccine before it has met the agency's rigorous expectations for safety and effectiveness. Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA, through our thorough review processes and science will guide our decisions. FDA will not permit any pressure from anyone to change that. I will fight for science, Mr. Chairman. I will fight for the integrity of the agency, and I will put the interest of the American people before anything else. Thank you and I look forward to answering your questions.

Full written testimony by Department of Health and Human Services officials