COVID Vaccines: Emergency Use Authorization Vs Full Approval
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The US regulator Food and Drug Administration (FDA) gave full approval to Pfizer-BioNTech COVID-19 Vaccine.
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It is now being marketed in the US as ?Comirnaty', for the prevention of COVID-19 disease in individuals 16 years of age and older.
Image Courtesy: Unsplash | Source: FDA
It is the first Covid vaccine to get the full approval while others have been given Emergency Use Authorization.
So, what is the difference between Emergency Use Authorization and full approval?
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Emergency Use Authorization (EUA) is a regulatory mechanism to allow the use of vaccines and medicines to prevent and/or reduce the impact of life-threatening diseases or conditions as caused by COVID-19.
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Before granting the EUA, regulatory authorities like Drugs Controller General of India, FDA conduct rigorous assessments of laboratory and clinical trial data, including data on quality, safety, production of protective antibodies and efficacy.
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Is the EUA a new process introduced for COVID-19 Vaccine?
Concept of EUA always existed to save the lives of people with vaccine and medicines for life threatening diseases while companies continue to obtain additional safety and effectiveness information to enable full licensure.
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Prior to COVID-19 vaccines, EUAs have been granted to vaccines for outbreaks due to Anthrax, Ebola, Enterovirus, H7N9 Influenza, and Middle East Respiratory Syndrome.
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Full approval is a step in the process of making a vaccine available for the public. Full licence is obtained when the manufacturer submits the complete data.
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Full approval is granted when, over time, the regulatory body has amassed even more scientific evidence to support use of the vaccine/medicine, showing that the benefits are greater than its risks, and that it can be manufactured reliably, safely and with consistent quality.
Image Courtesy: Unsplash | Source: FDA