patient safety & quality
By J . Hudson Garrett Jr ., PhD , MSN , MPH , MBA , FNP-BC , IP-BC , PLNC , CFER , AS-BC , VA-BC , MSL-BC , CPPS , CPHQ , NREMT , CADS , FACDONA , FAAPM , FNAP
Breaking Down the FDA ’ s EUA Vaccine Review Process
While the vaccine regulation process in the United States may not be perfect , it is still the most robust system of its type globally and provides significant oversight to new medications being considered for use in the country .
Over the past year and a half , there has been a tremendous amount of media coverage regarding the currently three Emergency Use Authorized ( EUA ) COVID-19 vaccines available in the United States . Understandably , many consumers and healthcare practitioners are not familiar with the relatively new EUA process that is orchestrated by the Food and Drug Administration ( FDA ).
There are multiple phases of clinical trials that exist , beginning at Phase 1 through Phase 4 . Phase 1 trials focus on whether or not the medication is safe . Phase 2 trials add to the findings of Phase 1 trials by determining whether there is truly efficacy or effectiveness of the medication . Phase 3 trials then combine the safety and efficacy clinical outcomes in a larger study population , especially one that is representative of the disease in question . After Phase 3 trials have concluded and the data has been analyzed , the medication is submitted to the FDA for review and consideration of licensing . Prior to FDA ’ s final decision being reached regarding new medication approval , the FDA utilizes the services of it ’ s external Advisory Board for further independent review of the
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medication ’ s safety and efficacy profile based on submitted clinical data . In addition , once the FDA issues its approval of a new vaccine , the CDC ’ s Advisory Committee on Immunization ( ACIP ) then makes formal recommendations regarding vaccine administration practices , which was the case for the recent three EUA COVID-19 vaccines .
The FDA ’ s medication review process is quite intensive by design and is charged with identifying any significant safety and / or efficacy concerns that might exist with the new medication . Phase 4 trials take place after the new medication is distributed in the market and serve the purpose of ongoing surveillance and monitoring for safety related concerns such as unexpected adverse events . In addition to the ongoing Phase 4 trials , the Centers for Disease Control and Prevention ( CDC ) has also launched an additional safety tracking mechanism specific to the COVID-19 vaccine , which is called vSAFE , which serves as a direct communication tool between public health experts at the CDC and the actual individual vaccine recipients .
The Emergency Use Authorization approval process is a multistep process for any potential new medication and begins with the presence of a confirmed public health emergency . For an
EUA to be granted by the FDA , four basic criteria must be met :
➊ The presence of a serious or life-threatening condition must be present ➋ Evidence of effectiveness of the new medication demonstrating benefit for the specific targeted disease ➌ The risk-benefit analysis for safety must be substantial , and ➍ There are no other alternatives that exist to treat the condition or disease
Once the declaration of the public health emergency is made ferally , then drug manufacturers that have potential products that would be relevant to the public health threat can request a pre-EUA submission meeting with the FDA . This collaborative type of meeting facilitates a much more productive dialogue and expedites the submission of a new product to the agency for EUA consideration . The new medication can then be submitted to the FDA for consideration of EUA approval , followed by the agency ’ s determination to either approve or reject the submission . Finally , the EUA approval is terminated once the declared public health threat is over and the public health emergency declaration is rescinded . Once a declared public health emergency is over , the drug manufacturer is expected to work with the FDA to submit the medication for full FDA licensing approval .
The COVID-19 pandemic has required the engagement of multiple federal , state , and local public health agencies , the assistance of private industry partners , and the continued collaboration with researchers , clinicians , practitioners , and many more across the entire healthcare continuum of care . While the vaccine regulation process in the United States may not be perfect , it is still the most robust system of its type globally and provides significant oversight to new medications being considered for use in the country . The next step in the COVID-19 vaccination process is widespread education of frontline healthcare providers on the various types of COVID-19 vaccines and frequently asked questions that patients may commonly ask . Regulatory review and approval , ongoing clinical research regarding safety and clinical outcomes , and healthcare provider education on vaccines will help curb the ongoing pandemic threat .
J . Hudson Garrett Jr ., PhD , MSN , MPH , MBA , FNP-BC , IP-BC , PLNC , CFER , AS-BC , VA-BC , MSL-BC , CPPS , CPHQ , NREMT , CADS , FACDONA , FAAPM , FNAP , is president and CEO of Community Health Associates , LLC , and also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine . Garrett is a frequent lecturer globally on patient safety , infectious diseases , and medical device reprocessing and safety . He may be reached at :
Hudson . garrett @ chaassociates . com www . healthcarehygienemagazine . com • july 2021
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