Thursday, September 9, 2021

Marla Ahlgrimm: Vaccine Approval Vs. Authorization

Marla Ahlgrimm

By now, all know that the FDA has approved at least one vaccine for COVID-19. But, two others remain in Emergency Use Authorization stage. Marla Ahlgrimm answers questions about the difference below. 
Q: What is the difference between approval and authorization? 
Marla Ahlgrimm: In virtually all other situations, approval and authorization mean the same thing. When it comes to the FDA, however, Approval is a term that denotes that long-term studies have taken place on the medication or device in question and that it has been deemed safe for widespread use. Authorization means that the FDA believes that using an unapproved product, in this case, a vaccine, is safer than not using it. 

Q: Why does it take so long to get Approval or Authorization? 
Marla Ahlgrimm: While it might seem that vaccines have been authorized for emergency use with haste, this simply isn’t true. FDA reviewers, physicians, and scientists read over the data extensively, and there is some testing involved. The authorities involved will utilize a combination of prior experience and data derived from multiple sources to either approve or deny a request for use.  
Q: What is FDA Clearance? 
Marla Ahlgrimm
Marla Ahlgrimm:
FDA Clearance is a designation typically applied to devices, such as heart monitoring apps and in-office x-ray devices. 
Q: Should I take the vaccine even if it has not been assigned the Approved status? 
Marla Ahlgrimm: Yes, in most cases. The vast majority of adults and children of age alike will greatly benefit from taking the vaccine. As new variants continue to emerge, the more protection we can give ourselves and our families, the better. Since one has already been approved, chances of others following suit are great.