What is Emergency Use Authorization (EUA)?
As the number of cases of coronavirus across the country surges again, the acronym EUA has made its way into news reports and everyday conversations. It was coined by the U.S. Food and Drug Administration (FDA) and stands for Emergency Use Authorization. This term refers to the process of getting treatment and prevention products to market quicker than usual.
During public health emergencies the FDA recognizes the need to accelerate the approval process of life-saving vaccines and other products, while still maintaining the safety and integrity of the process. The COVID-19 crisis is one such emergency.
To help address some of the concerns and myths about an EUA, we’ll answer a few of the most commonly asked questions.
How Does an EUA Work?
When there is a health emergency that presents serious or life-threatening risks to the public, the FDA may allow manufacturers of vaccines, medical supplies, or equipment that hasn’t yet been approved for use to be approved at an accelerated pace and distributed. This is especially true when lives are at stake and there are no other alternatives.
As a result of the current coronavirus epidemic, 2 drug manufacturers, Pfizer and Moderna, requested such an approval. Each submitted their case to the FDA in hopes of hastening the process of putting COVID-19 vaccines in the hands of the health care professionals who administer them.
Does an EUA Mean Products Aren’t Tested First?
Even with the accelerated process an EUA provides, all products and vaccines still undergo clinical trials. Manufacturers must conduct a 3-phase clinical trial with at least half of the phase 3 participants having undergone 2 months of follow-up after completing the trial.
In the case of the COVID-19 vaccine, the FDA requires that the “evaluation of an EUA request for a COVID-19 vaccine includes evaluation of the chemistry, manufacturing, and controls information for the vaccine. Sufficient data should be submitted to ensure the quality and consistency of the vaccine product.”
Another requirement is that the EUA include the manufacturer’s plan for active tracking and follow-up. The plan for drug manufacturers that request an EUA for COVID-19 vaccinations must include the documentation of adverse reactions, serious side effects, hospitalizations, and deaths for people who have received the vaccine.
Is the COVID-19 Vaccine Safe?
This is probably the most common concern people have about being vaccinated against COVID-19. Because the vaccine was developed much more quickly than previous vaccines, many are wondering if corners were cut in the haste to manufacture and deliver it.
The Centers for Disease Control and Prevention (CDC) and the FDA say the public should be reassured that the vaccine is safe and effective. Drug manufacturers must still adhere to a very strict scientific and regulatory process despite the current pandemic.
Find More Answers about COVID-19 Vaccines
Biotechnology Innovation Organization (BIO), the world's largest trade association representing biotechnology and biopharmaceutical companies, combined with academic institutions, state biotechnology centers, and related organizations created a website you might find useful in learning more about COVID-19 vaccines.
COVID Vaccine Facts contains articles and information to explain everything from how the vaccines are developed to how much it costs to be vaccinated. (Spoiler alert: there is no cost to receive the vaccine.) The site even features a search engine that allows you to enter a question about the vaccine and receive an immediate answer.
COVID-19 Vaccines for Senior Living Team Members
As caregivers to a population at high risk for the coronavirus, the CDC has recommended assisted living staff, along with residents, receive the highest priority for getting the COVID-19 vaccine.
This article belongs to Sunrise Senior Living and was written on December 14. This article is informative regarding EUA and we appreciate the information.