The phrase “emergency use authorization” is becoming part of our talk about COVID-19 vaccines that are awaiting final government approval for distribution. But, what constitutes emergency use?
Sandy Salverson, vice president of Pharmacy Services for OSF HealthCare, says the process was developed for situations -- such as the H1-N1 flu in 2009 -- in which the country didn't have existing drug therapies to support treatment that are needed quickly and on a large scale.
"One of the drugs that we know today as Tamiflu, at that time had no approval for infants and H1N1 was really impacting our kiddo population (Pediatrics) and so they (the Food and Drug Administration (FDA)) went through and evaluated the evidence that they had on efficacy and safety and opted to implement an emergency use authorization at that time."
Salverson says the FDA criteria for EUA explicitly outlines vaccines cannot pose a risk that would put someone in the hospital or cause serious side effects.
The Food and Drug Administration can make a judgement that it’s worth releasing something for use without the typical timeline for a new vaccine or drug.
