By: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
The development of safe and effective vaccines to prevent SARS-CoV-2 infection and/or COVID-19 is essential to help bring the pandemic under control.
The U.S. Food and Drug Administration is committed to making decisions that are guided by science and data regarding the authorization or approval of COVID-19 vaccines. The process of vaccine development and FDA’s evaluation of the safety and effectiveness of these vaccines is and will continue to be as open and transparent as possible. Why is this so important? Transparency in FDA’s processes can help people feel more confident in receiving COVID-19 vaccines, which is critical to their widespread use.
The FDA is limited by our governing statutes and regulations in what we can say during our review of unapproved products, including unapproved vaccines. But one important – and transparent – part of our regulatory and scientific evaluation process is to seek advice from outside experts through meetings of FDA advisory committees. When a scientific, technical, or policy question arises, the FDA often relies on its advisory committees to provide independent evaluation and advice. Committee members include external scientific experts – such as physicians, researchers and statisticians – and others who provide the perspective of the patient or consumer and industry.
This week, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. The committee will hear presentations from experts in COVID-19 disease and vaccine development, as well as from career FDA scientists. Topics will include studies needed to support authorization or approval, post-marketing safety studies needed following an approval, and what would be necessary for ongoing safety monitoring following issuance of an emergency use authorization for a COVID-19 vaccine.
There will also be a part of the meeting during which members of the public will have an opportunity to speak and provide input, and this will be followed by a thorough discussion of the issues by the committee members. The members of this committee are external scientific and public health experts from around the country, specializing in fields such as immunology, virology, infectious diseases, pediatrics, vaccine development, and vaccine safety. Discussions by this committee will help ensure clear public understanding of the data needed for FDA authorization or approval of COVID-19 vaccines, as well as plans for their continued evaluation following authorization or approval.
The October 22nd meeting will be streamed on the FDA’s YouTube channel to ensure that the discussions are transparent and available to the public. On October 6th, the FDA posted its briefing materials, making the public aware of the topics that will be addressed during the meeting. The agenda and roster of members are available today.
To further ensure transparency regarding COVID-19 vaccines, the FDA intends to schedule additional meetings, as needed, of the VRBPAC to obtain the committee’s advice on questions pertaining to requests for authorization or approval of specific COVID-19 vaccines. We will announce any upcoming meetings of this committee via a notice of meeting in the Federal Register and on the agency’s web site.
Facilitating the development of safe and effective COVID-19 vaccines is a high priority for the FDA. We recognize that being transparent about the data that we will evaluate in support of the safety and effectiveness of these vaccines and discussing this data with members of the VRBPAC in a public forum is critical to build trust and confidence in their use by the public.