Dr. Hahn's remarks to the National Consumers League on the vaccine review process September 29, 2020

Speech | Virtual

• Speech by: Stephen M. Hahn, M.D. ; Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )

Dr. Hahn's opening remarks:

Thank you, Sally.

I want to thank the National Consumers League for hosting me today. One of my first things that I did when I became commissioner, was to establish strategic priorities and one of them was to make sure, and to ensure that we heard the consumer's voice.

And so, this is a really important event, and I am so happy to have this dialogue with you today.  I’ll just make a few brief remarks before we get started with the Q and A.

Your organization has a deep understanding, as you mentioned, of the role that the FDA plays in protecting and promoting the health and safety of American patients and consumers, and we are so pleased to work with you in support of the mission of consumer protection and promoting the public health.

Today, I want to talk to you about the FDA's continuing efforts to address the COVID-19 public health crisis, and to focus on one aspect that I know is on everyone's mind, the continuing efforts to develop a vaccine and the FDA's role and responsibilities in that process.

We've all been immersed in this pandemic for nearly eight months, and during that period, the virus has turned our world upside down.  Families, communities and governments have worked tirelessly to adapt, make adjustments in the way we live, learn and socialize.

We've altered behaviors, and we've altered our daily lives, and far too many of us have had to face the personal consequences of this novel infectious disease. So, I'd just like to take a moment and acknowledge the pain and suffering that's been associated with this, my condolences to those who've been touched by this disease and particularly those who have died because of this disease.

During that time we've also increased our understanding of the disease, discovering answers to a number of scientific and medical questions surrounding the SARS-CoV-2 virus. While our understanding of this virus is still far from complete, we are today far more aware of the dangers and challenges. 

That knowledge, as well as behavioral changes, plays an important role in our continuing efforts to defeat this disease. At the FDA, we have accumulated and analyzed a lot of information and data, generated substantial regulatory flexibility, and incorporated novel thinking and innovation in our efforts to find answers and solutions. 

Much of our success is due to the diligence and commitment of FDA's incredible workforce, more than 17,000 plus, incredible public servants who are truly committed to our public health mission. I believe that FDA's employees are truly one of the shining stars of government and public health. 

Every day, I'm impressed by the professionalism, knowledge and dedication to this mission of consumer protection that all of us at the FDA bring to their jobs. 

Our employees have done remarkable work, not only in responding to the COVID-19 pandemic, but also in continuing to fulfill the agency's regular mission critical responsibilities, working around the clock, with a workload double the normal amount.

Of course, this kind of responsibility comes with unprecedented public scrutiny and sometimes yes, criticism. Any agency that has the broad responsibilities and far reaching impact of the 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 the FDA and our commitment to protecting public health.

I am confident and I believe the public should have great confidence, 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 the pandemic.

I know that there's been particular attention paid to a few of the decision reached by FDA scientists over the past few months.  As Commissioner, it's my responsibility to help explain why support for, in confidence to the FDA is justified. And I want to assure you that every one of the decisions we have reached, has been made by FDA scientists based on science and data, not by politics.

Often, we must make real-time decisions based on ever evolving data concerning this previously unknown, highly contagious virus that we are still learning about. And sometimes it's necessary to reverse decisions, as new data emerge.

Now this approach is inherent to something that you've all probably heard about, called the Emergency Use Authorization process, sometimes referred to as an EUA. It's really kind of how a doctor might approach a patient in an emergency situation, by regularly updating a treatment plan as new data emerge, but initially making a decision based upon an initial data set that come to us, for example, in the emergency room or the intensive care unit.

The fact is, the vast majority of the agency's decisions occur with little or no fanfare or criticism. Our decisions have contributed to the nation's response to the pandemic, and in each case, the basis for those decisions was the best available science and our commitment to protecting public health.

As I look back on the hundreds of decisions made by the FDA over the past six months, I submit that the agency's record is a remarkable one, worthy of the public trust. If, and when we approve or authorize the vaccine, the public should have complete confidence in that decision as well, the development of vaccines and therapeutics to prevent and treat COVID-19, holds the promise to alter the course of this pandemic.

We certainly want new products to come to market as quickly as possible to prevent additional illnesses and deaths. But if the national vaccine campaign is going to be successful, the American public must have full trust in the FDA's review process.

So I'd like to lay out the process FDA will use to review vaccines for COVID-19, and of course, we'll take any questions that you have regarding that.  As you know, there's a number of developers, we call them sponsors, who are currently developing potential vaccines to prevent COVID-19. 

In the guidance we issued on June 30th, 2020, the FDA made clear recommendations about what safety and effectiveness data we will need to see before we can review and approve a vaccine.

Once a vaccine sponsor reaches the conclusion that the data from its phase three clinical trials are adequate enough to submit to FDA, they will decide whether to apply for approval or for authorization under the EUA pathway. This will be based upon the phase three clinical trial, meeting pre-specified success criteria that were established by the sponsor, but which should be consistent with the recommendation in FDA's guidance.

We will receive that application or submission and our career scientists will review its safety and efficacy data.  We will also look at manufacturing quality and consistency. 

Following that, we plan on seeking advice from the Vaccines and Related Biological Products Advisory Committee, comprised of members who have been screened for ethics conflicts. They'll do this at a transparent and open committee meeting. 

The safety and effectiveness data and the committee's discussion will be public, although we will need to adhere to confidentiality requirements. The public will have an opportunity to make statements, the process will be transparent and independent.

FDA career staff will then take the committee input into account as they make their decision regarding the application or EUA requests.  Before we issue an EUA or approval, the FDA would have to determine among things, and this is particular for the EUA, that the vaccine’s benefits outweigh its risks.

We expect that this criteria would be based on the data from at least one well-designed phase three clinical trial that demonstrates its safety and efficacy in a clear and compelling manner. The FDA also expects the EUA requests would include a plan for active follow-up, to monitor safety among individuals who receive the vaccine data. 

Information from that continued monitoring would inform ongoing evaluation, the benefit risk, determination, and whether to support the continuation of the EUA. 

As we move forward, I want to commit to the American public several important things.

First, the FDA will not authorize or approve any COVID-19 vaccine before it has met the agency's rigorous expectations for safety and effectiveness. The FDA will not authorize or approve any vaccine that we will not feel comfortable giving to our own families.

Second, decisions to authorize or approved any COVID-19 vaccine or therapeutic will be made by the dedicated career staff and scientists at FDA through our thorough review processes.

And third, science will guide our decisions, FDA will not permit any pressure from anybody to change that. 

We can emerge from this pandemic only if we work together, learn from each other and are driven by facts and data.

As I mentioned recently, I will fight for science and data to guide our decisions.  The FDA will do its part with its usual scientific rigor, integrity, and with the public interest at the center of everything.  Of that the public can be sure.

Thank you Sally, and thank you NCL.