RESPONSE FROM THE FDA ON MY LETTER TO DR STEPHEN HAHN
RECEIVED 23 SEPTEMBER 2020
CBER OCOD Consumer Account <cberocod@fda.hhs.gov>
2:21 PM (6 hours ago)
to sniazi3@uic.edu
Dear Dr. Sarfaraz:
Thank you for your recent email to Dr. Stephen Hahn, Commissioner of Food and Drugs, concerning the development of vaccines to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. We appreciate your interest in this important topic.
The FDA recognizes the urgent need to develop vaccines to prevent COVID-19, and we are working collaboratively with industry, federal, domestic, and international partners to accelerate this work. We are committed to working with these partners to efficiently advance the development of safe and effective vaccines intended to prevent COVID-19. The nature of a particular candidate vaccine and its intended use may impact the specific data required to advance the development and licensure of that vaccine. Please note that the goal of these development programs is to demonstrate safety and effectiveness of a vaccine for the prevention of COVID-19. We are committed to working with these partners to efficiently advance the development of safe and effective vaccines for COVID-19. We also recognize that transparency around the FDA’s review, evaluation and decision-making with respect to COVID-19 vaccines is likely to impact public confidence in these vaccines and we are committed to being as transparent as possible throughout the process.
When making decisions about Emergency Use Authorization (EUA) or licensure of COVID-19 vaccines, we will apply the relevant statutory and regulatory requirements in the Federal Food, Drug, and Cosmetic Act and the Public Health Service (PHS) Act. FDA staff involved in the evaluation of vaccines are highly qualified scientists and physicians who are knowledgeable about the complexity of vaccine development. The same FDA scientists and physicians who routinely advise sponsors on vaccine development programs, manufacturing considerations, and assessment of safety and effectiveness of all vaccines are the experts who are focused on the work related to COVID-19 vaccine development.
As with all vaccines, the FDA requires that vaccine developers provide sufficient data to the FDA to evaluate the safety and effectiveness of the vaccine for its intended use and population. The FDA is working with vaccine developers to help ensure that ongoing and planned clinical trials will provide sufficient data to support approval of safe and effective COVID-19 vaccines in the United States.
We understand that there may be a perception that typical vaccine development steps are being skipped, but please know that FDA scientists will not allow corners to be cut in the fundamental steps required for vaccine development. In addition, the FDA will thoroughly evaluate the data submitted in support of a vaccine candidate’s safety and effectiveness and will only authorize or approve a vaccine for the prevention of SARS-CoV-2 infection and/or COVID-19 if the vaccine meets the Agency’s statutory and regulatory standards.
After issuance of an EUA or approval of a BLA for a COVID-19 vaccine by the FDA, FDA will continue to closely monitor the safety of COVID-19 vaccines various existing surveillance systems and, when appropriate, require the manufacturer to conduct post-marketing studies to further assess known or potential serious risks.
The FDA’s guidance entitled, Development and Licensure of Vaccines to Prevent COVID-19, addresses considerations regarding EUA of an investigational vaccine – and makes clear that an assessment regarding using any potential EUA for a COVID-19 vaccine would be made on a case-by-case basis considering the target population and the totality of the relevant, available scientific evidence, including preclinical and human clinical study data of the product.
The guidance reflects the recommendations and advice the FDA has been providing over the past months to companies, researchers and others, and describes the Agency’s current recommendations regarding the data needed to facilitate the manufacturing, nonclinical and clinical development, and approval of COVID-19 vaccines.
Additionally, the guidance provides an overview of key considerations to help manufacturers satisfy requirements for chemistry, manufacturing and controls, and nonclinical and clinical data needed for development and licensure and for post-licensure safety evaluation of vaccines. The guidance explains that, given our current understanding of SARS-CoV-2 immunology, the goal of development programs at this time should be to support traditional FDA approval by conducting studies to directly evaluate the ability of the vaccine to protect humans from SARS-CoV-2 infection and/or disease.
The guidance document provides transparency about the FDA’s current thinking about the scientific data needed to support approval of safe and effective COVID-19 vaccines. As part of these efforts to communicate about our expectations, we recently updated our guidance agenda to include an upcoming guidance on EUAs for vaccines to prevent COVID-19. The new guidance will expand on our June guidance, and is intended to provide sponsors of requests for EUAs with recommendations regarding the scientific data and information necessary to support issuance of an EUA.
Also, on October 22, 2020, the FDA will convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC), a panel of outside, independent, technical experts from various scientific and public health disciplines that provide input on scientific data and its public health significance in a public forum. The VRBPAC will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting. This advisory committee for the FDA is the appropriate advisory committee to obtain input on scientific issues related to the development of vaccines to prevent SARS-CoV-2 infection and/or COVID-19. Given the widespread potential use of these vaccines, transparent discussion at VRBPAC will help ensure clear public understanding of the evidence supporting vaccine safety and effectiveness. While the October 22nd meeting is not intended to discuss any particular vaccine candidates, the agency is also prepared to schedule additional meetings of the Committee promptly following submission of a request for an EUA or BLA for a COVID-19 vaccine to further ensure transparency.
Further details on this meeting are available on the FDA’s website at https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-22-2020-meeting-announcement.
We will continue to explore additional mechanisms to be as transparent as possible about our decision-making and general thinking regarding vaccines to prevent SARS-CoV-2 infection and/or COVID-19 disease.
We sincerely appreciate your concerns and interest in this topic, as well as the opportunity to provide this information to you.
Sincerely,
Hope Anderson
Health Communications Specialist
Center for Biologics Evaluation and Research
Office of Communication, Outreach and Development
U.S. Food and Drug Administration
Tel: 240-402-8010