America’s Gold-Standard Agency Will Authorize Coronavirus Vaccines

U.S. FDA’s highest priority is ensuring the quality, safety, and effectiveness of vaccines
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‘The U.S. Food and Drug Administration’s (FDA) 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,’ said Stephen M. Hahn, M.D., Commissioner of FDA and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, in an editorial published on September 11, 2020.

‘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.’

‘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 worldwide 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 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 the 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.’

An upcoming key milestone is the meeting of our Vaccines and Related Biological Products Advisory Committee on October 22, 2020, 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 Biologics License Applications (BLA) or requests for EUAs to further ensure transparency.   

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,’ concluded these excerpts from Dr. Hahn’s comments.

CoroanvirusToday publishes research-based COVID-19 therapeutic and related vaccine news.