Washington, D.C. – This week, in an Oversight and Investigations Subcommittee hearing with public health experts, the Energy and Commerce Committee continued oversight of the development and safety of potential COVID-19 vaccines. This follows the hearing the subcommittee held on COVID-19 vaccines with drug manufacturers and other aggressive oversight work through the pandemic.
These were the witnesses:
- Helene Gayle, M.D., M.P.H., Co-Chair, Committee on Equitable Allocation of Vaccine for the Novel Coronavirus, National Academies of Sciences, Engineering, and Medicine
- Ashish K. Jha, Dean, M.D., M.P.H., Dean, School of Public Health, Brown University
- Ali S. Kahn, M.D., M.P.H., M.B.A., Dean, College of Public Health, University of Nebraska Medical Center
- Mark McClellan, M.D., Ph.D., Founding Director, Duke-Margolis Center for Health Policy, Duke University
- Paul A. Offit, M.D., Director, Vaccine Education Center, Children’s Hospital of Philadelphia
Here are some of the highlights:
Many Safeguards Are in Place for a COVID-19 Vaccine Approval Process
Energy and Commerce Committee Republican Leader Greg Walden (R-OR) shared many of the safeguards in place for the COVID-19 vaccine approval process.
“For example, FDA has issued rigorous guidance for these vaccines, and each of the Phase 3 trials are enrolling at least 30,000 participants. In addition, FDA has multiple existing safeguards in place to ensure science-based decisions. These include standards for the vaccine review process, the Emergency Use Authorization review process, and the necessary evidence required to receive an approval that meets FDA’s gold standard. Further, there are multiple safeguards outside of the FDA. For example, each of the Phase 3 trials will be overseen by the Data and Safety Monitoring Board, or DSMB. The DSMB is an independent, multidisciplinary group which includes individuals who are experienced with clinical trials, biostatisticians, bioethicists, immunologists, vaccinologists, and virologists. The purpose of the DSMB is to oversee and monitor clinical trials to ensure participant safety and the validity and integrity of the data. In addition, all four companies in Phase 3 trials have published their clinical trial protocols to provide even more transparency. There are also independent experts who serve on an FDA Advisory Committee who will scrutinize safety and efficacy data of the vaccine candidates. The evidence required for these vaccines is consistent with the FDA’s gold standard that has made the vaccine supply in the U.S. reliable, safe, and effective.”
All the Guardrails in Place Should Make it Difficult to Politicize the COVID-19 Vaccine Approval Process
Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) listed guardrails in place, such as the Data Safety monitoring boards, and asked if these are “sufficient to prevent undue pressure” on the FDA or the vaccine approval process.
Dr. Offit: Yes, and there’s a third thing. The Advisory Committee for Immunization Practices. Once a vaccine is licensed or approved, [the committee] will independently review data and independently make a decision about how they would recommend giving that vaccine. I, like you, am worried about the politicization of science but I do think it would be hard to politicize this.
The Emergency Use Authorization Process is Similar to Full Approval
Oversight and Investigations Subcommittee Republican Leader Brett Guthrie (R-KY) asked about the extensive scientific data that vaccine manufacturers would have to submit for an EUA and how that compares to full FDA approval.
Dr. McClellan: I had a chance to talk with Dr. Peter Marks at a public event last night where he reiterated that he expects the evidence for the safety and effectiveness for a vaccine approved under an EUA to be very similar to that for a full approval. Remember, the full approval includes a lot of additional documentation, thousands and thousands of pages dealing with a lot of issues like is the vaccine going to be stable on a shelf for the next six months. That is not the context that we are concerned about here. And to make sure all of this is not only reviewed fully by the FDA as Dr. Offit said, there will be an advisory committee meeting for each vaccine -each vaccine – that comes forward with an emergency use application for the FDA…
Unlike Russia and China, the United States is Only Going to Approve or Authorize COVID-19 Vaccines with Large Phase 3 Clinical Trials That Meet High Safety and Efficacy Standards
Walden asked how the COVID-19 vaccine approval system in Russia and China is different than the approval process in the United States.
Dr. McClellan: In China and Russia, there are people getting vaccines now that have not been through anything like the process that we’ve described. These large so-called phase 3 trials that actually have to prove, demonstrate, that a vaccine reduces the number of infections, reduces severe infections – that have these very large databases of tens of thousands of people who have been followed after they get the vaccine, that have the FDA’s authority… to set up additional monitoring on the people who are first to get the vaccines: our first responders, our health professionals and others who are at such big risk today because of the ongoing pandemic. It’s very different. It’s a system that really is setting the standard for the world.
Dr. Kahn: In Russia, the vaccine was licensed with less than 100 people who have been vaccinated in a phase 1/2 trial. That is impossible in the United States.
No Corners are Being Cut
Rep. Markwayne Mullin (R-OK) asked if corners were being cut with the development of a COVID-19 vaccine.
Dr. McClellan: While the Warp Speed process is happening much faster and I know that makes people nervous about cutting corners, it’s important to recognize though that the FDA is firewalled off, even from Warp Speed, so the work that the government is doing in Operation Warp Speed with the companies – on additional manufacturing and on supporting these very large trials with NIH getting them up and running at an unprecedented pace – is different from the review that’s going on independently by FDA. It’s sort of like independent oversight within this very accelerated process, and that’s FDA’s role to make sure we are not cutting corners on the safety and effectiveness evidence.
States Are Not Able to Replicate FDA’s Gold Standard of Vaccine Review
Walden asked if a separate review of a COVID-19 vaccine from states is necessary, if states are equipped to do their own review, and if a separate state review would slow down access to a vaccine that could save lives.
Dr. McClellan: …I do have some concerns about it. We just talked about how extensive and developed … FDA’s process [is]. That’s a process that you all have supported through your … continued efforts to strengthen and improve the Federal Food, Drug, and Cosmetic Act, which is meant to provide a high level of confidence about [the] safety and effectiveness of medical products in general, and vaccines in particular, for the American people. It is a huge undertaking with a lot of expertise, experience…. It is hard to see what a state body of some kind could add to that. I understand where the impulse is coming from. Maybe if what the group could do is just go through this kind of checklist. Are all the things we talked about today – are they actually happening? Are we hearing from the career staff? Is the process being followed? Maybe that could help improve confidence, but it’s hard to see how to replicate anything like this national gold standard system that we’ve developed.