The Food and Drug Administration (FDA) is known for its strict standards. They help to ensure that the products we consume are safe and effective. You may have been hearing about the FDA and the term Emergency Use Approval (EUA) more and more due to the pandemic. But what does this term mean?
An EUA is a way to help speed up the use of medical interventions, including vaccines, during a public health emergency, like the current COVID-19 pandemic. Under the EUA, the FDA may allow the use of unapproved medical products, or unapproved uses for approved medical products in an emergency. These products may be allowed if they are used to diagnose, treat, or prevent serious or life-threatening diseases. However, these will only be used should no other alternatives be approved or available.
This is the case for the three EUA COVID-19 vaccines: Pfizer-BioNTech, Moderna, and Johnson & Johnson. These three vaccines went through multiple phases of testing where amount of vaccine, demographics, side effects and risks were measured. Once enough information was collected, they could apply for an EUA from the FDA.
Several rounds of studies need to be completed before a product can apply for EUA and eventually get the okay. Additionally, the FDA states that in order for an EUA to be issued for a vaccine, there must be production information to ensure quality and consistency of the product and the FDA must determine that the benefits outweigh the risks for the vaccine.
Overall, a lot of testing and research needs to go into a vaccine before it is considered safe and can be approved for the public. Much progress has been made in the creation of these vaccines and without the EUA, there is no telling how long it would take to get the help needed to end the pandemic. There is still a long way to go, however, thanks to emergency approval, we are on the right track.
Article proved by CHC Wellbeing