The FDA Director issued a statement expressing his commitment to maintaining the transparency of coVID-19's emergency use authorization

With the excellent Phase 3 clinical trial results of the new crown candidate vaccine developed by Pfizer/BioNTech and Modelna, the review of the Emergency Use Authorization (EUA) for the candidate new crown vaccine has also become one of the focus of attention.
, FDA Director Dr. Stephen M. Hahn issued a statement announcing the FDA's commitment to maintaining transparency in the EUA review process related to COVID-19.
following are the main elements of the statement.
Emergency Use Authorization (EUA) is an important tool in the fight against COVID-19 and other public health emergencies.
eua is not a new tool for the FDA, although the EUA received increasing attention during the COVID-19 public health emergency.
I would like to take a moment to reaffirm the FDA's commitment to transparency in the EUA process and provide more information about the FDA's decision to release, revise or withdraw EUA for pharmaceutical and biological products, including vaccines.
, we launched the COVID-19 Pandemic Recovery and Preparedness Program (PrePP) earlier this year to help apply best practices and lessons learned so far from emergency response.
our goal is to optimize our ongoing COVID-19 response while strengthening our resilience and our ability to respond to future public health emergencies.
as part of our overall preparedness and response efforts, we are focusing on further transparency.
we recognize in particular that the publication of information in support of the publication, revision or withdrawal of EUA's scientific review documents will help to increase public confidence in the strictness of FDA reviews and approved products.
So, as part of the COVID-19 response, our Center for Pharmaceuticals and Biologics plans to publicly publish the results of its review of scientific data and information in support of EUA applications to the extent permitted by law.
me to take a step back and explain why EUA is such a unique and important public health tool in an emergency.
EUA program, which comes from the powers congress gave the FDA after the September 11, 2001 attacks, can be applied to a variety of emergencies, including pandemics like COVID-19.
the EUA process, the Minister of Health and Human Services may, where appropriate, declare that the EUA is reasonable for certain products that respond to a particular threat.
FDA may issue a "authorization" when such a statement is made.
this is different from our approval process for drugs and biological products, including vaccines.
in accordance with the EUA process, the FDA reserves the right to authorize the use of medical products under certain conditions in the absence of appropriate approved and available alternatives in an emergency, until all the evidence required for full FDA approval is obtained.
EUA's request, the FDA should carefully evaluate all scientific evidence related to product safety and effectiveness in a timely manner to determine whether a medical product can be used effectively for its proposed authorized use.
as part of the EUA's overall assessment, the FDA must also determine that the known and potential benefits of the product exceed its known and potential risks.
. Stephen M. Hahn, director of the U.S.-China Food and Drug Administration (Photo: FDA.com), made it clear to me that the release of the EUA is based on data and science.
to obtain EUA authorization, FDA scientists rigorously evaluated scientific evidence related to medical products.
we work with the bid to continue to collect and review additional data on product safety and effectiveness.
if existing scientific evidence changes or new information is obtained, we can convert and potentially adjust the EUA, including modifying the authorized use or revoking the EUA.
these are the steps we took during the COVID-19 outbreak.
today's transparency initiative is just one of several steps we have taken to ensure public confidence in the EUA review process.
For example, as part of our commitment to transparency in COVID-19 vaccines, we convened the FDA Advisory Committee on Vaccines and Related Biological Products (VRBPAC) to convene an open committee meeting to discuss the development, licensing and authorization of COVID-19 vaccines.
Although no specific applications have been discussed at this meeting, we have publicly stated that we will arrange an additional meeting of VRBPAC immediately after receiving any EUA applications for coVID-19 vaccines to discuss whether current security and effectiveness data support the release of EUA.
we have also created educational materials to help the public understand the different regulatory and scientific steps regarding vaccine or drug development.
We will continue to help accelerate the development of COVID-19 vaccines and therapeutic drugs, providing rapid feedback and technical advice to bidders and researchers without sacrificing the quality, safety and effectiveness standards that everyone depends on.
we will continue to follow science and ensure that science remains a driver of FDA regulatory decisions in our fight against COVID-19 and other (public health events).
: . . . COVID-19 Update: FDA's Ongoing Commitment to Transparency COVID-19 EUAs. Retrieved November 17, 2020, from