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4 Myths About What It Means For A Vaccine To Be 'FDA Approved'
Myth: If COVID-19 vaccines aren’t (yet) FDA approved, they aren’t safe
While there are important distinctions between FDA approval and emergency use authorization, those words may be thought of interchangeably in at least one way: both mean the FDA considers the COVID-19 vaccines “safe and effective” for the groups indicated.
“In this case, both ‘authorized’ and ‘approved’ are flexible terms that basically mean the same thing in terms of quality and the high standards the FDA sets forth,” said Dr. Arnold Monto, a professor of epidemiology and global public health at the University of Michigan. “The FDA did not lessen the standards for anything, including the amount of time that must lapse, before an application for ‘FDA approval’ could be considered.”
To that end, the FDA spokesperson also left no room for doubt regarding the safety of the vaccines: “The FDA can assure the public and medical community that we have conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information for every vaccine authorized” and that “efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process.”
“With over 120 million people already vaccinated,” Bates said, “this is one of the largest field tests of a vaccine ever conducted, and this vaccine has so far been shown to be as safe and effective as the many medications and vaccines that have been fully approved.”
While there are important distinctions between FDA approval and emergency use authorization, those words may be thought of interchangeably in at least one way: both mean the FDA considers the COVID-19 vaccines “safe and effective” for the groups indicated.
“In this case, both ‘authorized’ and ‘approved’ are flexible terms that basically mean the same thing in terms of quality and the high standards the FDA sets forth,” said Dr. Arnold Monto, a professor of epidemiology and global public health at the University of Michigan. “The FDA did not lessen the standards for anything, including the amount of time that must lapse, before an application for ‘FDA approval’ could be considered.”
To that end, the FDA spokesperson also left no room for doubt regarding the safety of the vaccines: “The FDA can assure the public and medical community that we have conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information for every vaccine authorized” and that “efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process.”
“With over 120 million people already vaccinated,” Bates said, “this is one of the largest field tests of a vaccine ever conducted, and this vaccine has so far been shown to be as safe and effective as the many medications and vaccines that have been fully approved.”
https://www.huffpost.com/entry/myths-fda-approval-vaccines_l_609ac447e4b099ba752f567c
May we please stop it with the FDA full approval excuse?
1 replies
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