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The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health

This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. Note the spikes that adorn the outer surface of the virus, which impart the look of a corona surrounding the virion, when viewed electron microscopically. A novel coronavirus, named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), was identified as the cause of an outbreak of respiratory illness named coronavirus disease 2019 (COVID-19).
This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals the ultrastructural morphology exhibited by coronaviruses.

By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

The U.S. Food and Drug Administration’s mission is to protect and promote the public health, both in the U.S. and globally, by ensuring the safety and effectiveness of the products we regulate. Nowhere is this public health mission more evident than in the FDA’s role in the scientific and regulatory oversight of vaccines. One of the agency’s highest priorities is ensuring the quality, safety and effectiveness of vaccines. This deep and abiding commitment is something that we consider essential to engendering the public’s trust in vaccines.

photo of Stephen M. Hahn, M.D.
Stephen M. Hahn, M.D.

Why are vaccines so critical to helping end this pandemic? Vaccines are one of the most significant public health interventions ever implemented. They have been largely responsible for the dramatic reduction in serious adverse consequences and death related to infectious diseases such as smallpox, polio, and measles. In fact, smallpox has been eradicated world-wide and polio and measles have largely been eliminated from high income countries. The development of safe and effective vaccines to prevent SARS-CoV-2 infection and/or COVID-19 is essential to bringing the pandemic under control.

We are committed to making decisions that are guided by science and data regarding the authorization or approval of COVID-19 vaccines. A significant step in spurring the development of the data needed to demonstrate the safety and efficacy of these vaccines was the issuance of FDA’s guidance, Development and Licensure of Vaccines to Prevent COVID-19. The guidance document clearly outlines the FDA’s expectations for the development of these vaccines, including design of clinical trials, trial populations, safety and efficacy considerations, and information needed for our assessment of manufacturing and facility information. It also includes important recommendations for post-marketing safety. Finally, it outlines the potential circumstances under which the agency would consider an emergency use authorization for a COVID-19 vaccine. The FDA also intends to issue additional guidance shortly to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA.

We are often asked about clinical trials for COVID-19 vaccines and the importance of diversity in clinical trial participants. It is critical that we have vaccines that work for everyone. That is why the FDA strongly encourages enrollment of all people – including racial and ethnic minorities, older adults, pregnant women and women of childbearing age and, as appropriate, children – in clinical trials to test COVID-19 vaccines, as outlined in the recommendations in our guidance.

The FDA’s career scientists and physicians are helping to facilitate the development and evaluation of safe and effective COVID-19 vaccines. These professionals have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of vaccines intended to prevent infectious diseases. They are experts in clinical trial design and analysis and synthesizing and evaluating tremendous amounts of data to determine whether a vaccine has been shown to be safe and effective. These experts are responsible for assessing the adequacy of manufacturing and the facilities where vaccines are made, which are critical to producing high-quality vaccines, and for post-marketing safety surveillance, using a wide variety of surveillance systems and data mining to continually review safety after a vaccine is approved.  

CBER Director, Peter Marks, M.D., Ph.D.
Peter Marks, M.D., Ph.D.

The FDA is often held up as the “gold standard” of regulatory agencies around the globe. What’s at the core of these standards are the agency’s regulatory independence and science-based decision-making.  As with all products we regulate, we will follow the science and data in our decision making regarding COVID-19 vaccines. It is because the FDA is a science-based agency that we say this with the clarity of conviction. The dedicated career public health professionals who will be involved in evaluating the data submitted to the FDA in requests for Emergency Use Authorization (EUA) and in Biologics License Applications (BLAs) for COVID-19 vaccines are committed to decision making based on science and data. They are fathers, mothers, sisters, brothers, grandparents and more – and they (and their families) are directly impacted by the work they do. They are exactly who you want making decisions regarding vaccine safety and effectiveness.

No time in recent memory has shone as bright a light on the work of FDA review staff as the COVID-19 pandemic. We understand that a lot of people may not have information about vaccine development or how the FDA determines whether or not to approve a vaccine – and may not have given it much thought – at least until now. 

With so much at stake, we understand the importance of being as transparent as possible about the work we do, including how we will make decisions regarding COVID-19 vaccines. The publication of our guidance was an important step – we firmly believe that transparency regarding the FDA’s thinking about the scientific data needed to support approval of safe and effective vaccines will help build public confidence in the FDA’s evaluation process, which will be critical in ensuring the use of COVID-19 vaccines once available.  

An upcoming key milestone is the meeting of our Vaccines and Related Biological Products Advisory Committee on October 22, at which the committee will discuss publicly the general development of COVID-19 vaccines. While this meeting is not intended to discuss any particular vaccine candidates, the agency is also prepared to rapidly schedule additional meetings of this Committee upon submission of any BLAs or requests for EUAs to further ensure transparency.   

The FDA has been asked what regulatory path will be used to make COVID-19 vaccines available (i.e., will there be an EUA, or will the FDA approve a BLA?). The short answer is, taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request or BLA to the FDA. The agency will review EUA requests and BLAs received and make appropriate determinations by looking at the totality of the available scientific evidence. For a vaccine for which there is adequate manufacturing information, issuance of an EUA may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine, but before the manufacturer has submitted all of the various data elements normally required and/or the FDA has completed its formal review of the BLA. 

As we have said, these decisions will be firmly rooted in science. We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.

We’ve covered a wide range of topics related to the development, our evaluation of safety and effectiveness and potential availability of COVID-19 vaccines. In the coming weeks, we will take a deeper dive into some of these concepts, to provide clarity regarding the FDA’s role and responsibilities to the American public.


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