The Covid-19 pandemic has added many acronyms to the vernacular. The latest, 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 refers to the process of getting treatment and prevention products to market through a faster-paced approval process.
During public health emergencies like the pandemic we face today, the FDA recognizes the need to accelerate the approval process of life-saving vaccines and other products. They have an expedited path that honors the need for a rapid response. This path, the Emergency Use Authorization, works to shorten the time before a vaccine can be used while still maintaining the safety and integrity of the process. The COVID-19 crisis is one such emergency.
Here are a few common questions and misconceptions to alleviate concerns that you may have about an EUA, and how that relates to the vaccine.
How Does an EUA Work?
During a health emergency presenting serious or life-threatening risks to the public, the FDA allows vaccines, medical supplies, or equipment that hasn’t yet been vetted to be approved at an accelerated pace.
As a result of the current coronavirus epidemic, 2 drug manufacturers, Pfizer and Moderna, requested this EUA approval. Each submitted their case to the FDA expediting the process of getting COVID-19 vaccines in the hands of the health care professionals who administer them.
Does an EUA Mean Products Aren’t Tested First?
No. Even with the expedited process, all products and vaccines still undergo clinical trials. Manufacturers 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.”
Reassuringly, another requirement is that the manufacturers must plan for active tracking and follow-up. Drug manufacturers that request an EUA for COVID-19 vaccinations must include thorough documentation. This includes of adverse reactions, serious side effects, hospitalizations, and deaths for people who have received the vaccine.
How Long Has the Covid-19 Virus been Studied?
According to the Cleveland Clinic, “The older human coronaviruses were first identified in the mid-1960s.” Covid-19 is called that is because it’s the iteration of the SARS-CoV virus discovered in 2019. Epidemiologists have studied iterations of the SARS-CoV for quite some time. As a result, they already have a foundation of work to base their studies of the new virus on. This combined with modern advancements in medicine, gave the medical community the ability to more rapidly develop vaccinations.
Is the COVID-19 Vaccine Safe?
It is natural to be concerned about safety. Because the vaccine was developed so quickly, many are concerned. The incorrect assumption is that corners were cut in that haste.
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.
More Resources About COVID-19 Vaccines
In the era when information is routinely questioned, it’s important to seek multiple sources of information. COVID Vaccine Facts is a wealth of 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.) Their FAQ section is especially helpful.
For more information, please contact your Executive Operations Officer at your community. Stay Healthy!