The COVID-19 pandemic has basically been a crash course in medical lingo most of us would've never used otherwise: intubation, incubation periods, personal protective equipment (PPE).

Now, there's a new one you've likely been hearing more and more recently: emergency use authorization. Also known as an EUA, this specialty designation has been granted to several medications and even types of face masks during the COVID-19 pandemic so far. And currently, two major COVID-19 vaccines—the ones made by Pfizer and Moderna—have applied for an EUA and are waiting for approval, which may come as early as this week.

It's good news, of course—these EUAs help get necessary medications to people who need them as quickly as possible, but what exactly are emergency use authorizations, and why do we need them? Here's what you need to know.

What is an emergency use authorization?

An EUA is a special designation that allows the US Food and Drug Administration (FDA) to help strengthen the country's public health protections against chemical, biological, radiological, and nuclear threats by making medical countermeasures available for use during public health emergencies, the FDA says online.

Under an EUA, the FDA may allow the use of unapproved medical products or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions "when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives," per the FDA. With an EUA, manufacturers will submit a request for an EUA, it will be reviewed by the FDA, and then approved or denied.

The rights of the FDA to grant an EUA is given under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). That act says that the FDA commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a threat to public health when there are no adequate, approved, and available alternatives.

Why are emergency use authorizations necessary?

The FDA can't just issue an EUA on a whim: Section 319 of the Public Health Service Act says that a separate determination and declaration is needed to allow the FDA to issue EUAs, as long as other criteria is met.

Clearly, EUAs aren't issued under ordinary circumstances. "[They're] used during a public health emergency, when there is a need to have a product available to stop the public health emergency in a very rapid manner," infectious disease expert Amesh A. Adalja, M.D., senior scholar at the Johns Hopkins Center for Health Security, tells Health. "This is an expedited way for people to get access to products—vaccines and medications—through a pathway that allows these decision to be made much more quickly."

With an EUA, the "risk-benefit ratio is not what it would be in ordinary times," Dr. Adalja says. But, he adds, "time is of the essence" in these situations. "EUAs have been used during H1N1, Zika virus, Ebola, and now during COVID," Dr. Adalja says.

In the case of COVID-19, the secretary of the Department of Health and Human Services determined in early February that COVID-19 had "significant potential to affect national security or the health and security of United States citizens living abroad." Based on that, the secretary declared that circumstances existed for EUAs to be granted.

Since then, the FDA has issued EUAs for various diagnostic tests, ventilators, respirators, face shields, and decontamination systems for health care workers, along with numerous therapeutics like Veklury (remdesivir), bamlanivimab, and convalescent plasma therapy.

Are emergency use authorizations safe?

Doctors say yes and stress that, in the case of the COVID-19 vaccine, people should feel comfortable knowing that the vaccines have been studied heavily. "Before a clinical trial of a vaccine even starts, a Data and Safety Monitoring Board (DSMB) must be in place for that trial," Tim Murphy, MD, SUNY Distinguished Professor at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, tells Health. "A DSMB is made up of experts who review clinical trial data on an ongoing basis to ensure the safety of study subjects and the integrity of the data. DSMB members are independent and have no vested interest in a specific treatment."

"There is still a good deal of rigor required, and the vaccine trials—while faster than usual—have been rigorous," Jamie Alan, PhD, an assistant professor of pharmacology and toxicology at Michigan State University, tells Health. "I personally would feel very comfortable getting the COVID vaccine."

The process to get an EUA, though expedited, is still vigorous, Stanley H. Weiss, MD, a professor in the department of epidemiology at Rutgers New Jersey Medical School, tells Health. "There are clinical trials that involve a stated protocol that's vetted through quite a few parties," he says. "From there, the data goes to two critical issues that the public is concerned about: Does it work? And is it safe? The EUA contains information to answer both of those questions."

Once an EUA application is submitted to the FDA, it's reviewed by an independent advisory panel of national experts. In the case of the COVID-19 vaccine, it's the Vaccines and Related Biological Products Advisory Committee.

"This committee provides expert evaluation and recommendations to the FDA," Dr. Murphy explains. "The FDA career professionals then make a decision regarding an EUA, based on extensive data submitted by the manufacturer of the product and the recommendation of the vaccine advisory committee of experts."

"Therefore, in order for the FDA to issue an EUA for a COVID vaccine, the product must withstand multiple levels of rigorous review by independent scientists, healthcare professionals, biostatisticians, and ethicists," Dr. Murphy says. "Thus, we all have reason to be confident that a vaccine that has received an EUA by the FDA will be safe and effective. I will certainly get in line for such a vaccine as soon as I am eligible."

William Schaffner, MD, an infectious disease specialist and professor at the Vanderbilt University School of Medicine, tells Health that "the vetting is just as tough" for an EUA as it is for full FDA approval—the timeline is just shorter. "The Food and Drug Administration is tough and rigorous, and they would not give their thumbs up unless they were secure that this vaccine could be used in the general public safely," he says.

Also, know this, per Dr. Weiss: Companies and the FDA continue to collect data on products after an EUA is issued, with the eventual goal of full FDA approval.

The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources.

Source: Read Full Article