Coronavirus Vaccine: EUA vs. FDA Approval

COVID-19 numbers continue to rise across the United States and other parts of the world, claiming the lives of nearly 400,000 Americans, largely people from our Black and Latinx communities, creating even more urgency for a vaccine to be available as soon as possible for everyone.

Although creating a new vaccine can sometimes take years, many pharmaceutical companies are quickly advancing in research and clinical trials. Some companies have already successfully started distributing their vaccine to the more at-risk populations, such as health care personnel and older adults.

This means that the current vaccines available do not yet carry approval by the Food and Drug Administration (FDA), which may make some feel skeptical about the development process, but we are here to assure you that the COVID-19 vaccines are safe and effective.

“Once the science behind the COVID-19 vaccination is understood, there shouldn’t be hesitancy or fear,” explains Alric V. Simmonds Jr., MD, AdventHealth General Surgeon, Chief Health Equity Officer and Chief Medical Officer.

Operation Warp Speed

According to the U.S. Department of Health & Human Services (HHS), they are in partnership with the Department of Defense to help develop, make and distribute millions of vaccine doses for COVID-19 as quickly as possible. This mission is called “Operation Warp Speed” and has a goal to produce and deliver 300 million doses.

As of January 2021, two vaccines have been approved for public use in the United States, and both require two-shot doses for anyone wishing to be vaccinated once it is their turn to do so. Currently, AdventHealth is distributing vaccines in phases, based on CDC and state government guidelines. For more information about when the vaccine will be available to you, we encourage you to sign up for email alerts at www.CoronavirusVaccineAlerts.com.

The Clinical Trial Process

Once the vaccine application is approved, the vaccine can begin testing in clinical trials on adult volunteers. Clinical trials are conducted in three phases, and by Phase 3, the trial enlists thousands of people to learn more about how the vaccine works and how their immunity to the disease compares to those who have not received the vaccine.

Moderna, the biopharmaceutical company behind one of the available COVID-19 vaccines, shared that their 30,000-person Phase 3 study included more than 11,000 people from communities of color, including over 3,000 Black participants.

Pfizer, also a biopharmaceutical company behind an available COVID-19 vaccine, has stated that approximately 42% of their overall trial participants, and 30% of U.S. participants, have diverse backgrounds, with 10% being Black Americans.

The trial stage is important for providing the information the FDA needs to approve the vaccine.

At any stage, if the vaccine doesn’t seem to be safe or effective, the FDA may stop the study.

The vaccines currently available are EUA approved but they do not yet carry FDA approval. During a public health emergency, the FDA can use what they call an Emergency Use Authorization (EUA) authority to allow the use of unapproved products to treat or prevent serious, life-threatening diseases, such as coronavirus.

According to the FDA, before they can issue an EUA for a vaccine, the Secretary of Health and Human Services must make a declaration of emergency or threat to justify authorization of emergency use.

The FDA also explains that an EUA is a different standard than an FDA approval; however, in the case of an investigational vaccine developed for the prevention of COVID-19, both require submitting data demonstrating the vaccine’s safety and effectiveness.

What is Emergency Use Authorization?

While technically a vaccine needs to have FDA approval before the public can receive it, because COVID-19 is considered a public health emergency, vaccine manufacturers may choose to submit a request for an EUA.

EUA was initially established after the September 11, 2001 terrorist attacks to ensure that potentially lifesaving medical products could be made available during an emergency before being approved by the FDA.

In order to issue an EUA, it needs to be proven that the vaccine may be effective in preventing a serious or life-threatening condition, and that the vaccine’s known and potential benefits can outweigh its known and potential risks. The FDA has said that in order for a COVID-19 vaccine to be administered to the public, including healthy people, they only issue an EUA if a vaccine has demonstrated clear and compelling effectiveness in a large Phase 3 clinical trial.

“I am the chair of our scientific review committee for COVID-19, so we’ve had ample opportunity to really look at the scientific data — to look at the efficacy and the risk/benefit profile of this vaccination,” Dr. Simmonds explains, adding, “Quite honestly, I did have some initial hesitancy (about the COVID-19 vaccine), but I am a scientist, and I believe in the science.”

How Can a Vaccine Get FDA Approval?

After the three phases of clinical trials are complete, the vaccine manufacturer must present data to an FDA review team that proves the vaccine is safe and effective and that its benefits outweigh any risks.

Once a vaccine is approved, it must be properly labeled with its risks and benefits, as well as its correct use, so health care providers can share this information with their patients.

Before an approved vaccine can get distributed to the public, the manufacturer must test all batches of the vaccine, called lots, for safety, potency and purity. The FDA reviews this information before the lots can be released. The FDA also routinely inspects the facilities where the vaccines are produced to ensure the product’s safety and quality.

Calming Nerves and Skepticism

Now that the vaccine is starting to be more widely available to our at-risk groups, “we need people to get this vaccine so the community can return to some sense of normalcy and achieve that herd immunity we’ve been talking about,” says Dr. Simmonds.

“Vaccinations help populations of people survive grave illness,” he explains. “If you’ve gone to school, if you’ve played team sports, you’ve been vaccinated for measles, mumps, chickenpox, etc., so our bodies tolerate these things very well and they keep us safe.”

Even though vaccinations have been common in the United States for quite some time, there is still a large amount of fear and/or hesitance among our communities when it comes to the COVID-19 vaccination, particularly when it comes to Black Americans.

Dr. Simmonds explains: “People of color in this country have received intentional malady from government officials, and the community remembers that. There are atrocities that have been committed against people, that are historic in nature, but are readily available to the memory.” This is can be especially top of mind during a pandemic, when you think about a treatment being something that one must take into their own body, he says.

“So that distrust and hesitance is very real. We understand and we want to help people get to where they need to be to prevent this disease,” Dr. Simmonds explains.

Though he understands why some people are still unsure about the vaccine, Dr. Simmonds urges the community to look at the science behind it. “Please don’t let your fear prevent you from taking a vaccination that will save you,” he says. “If you do, you may end up like many of the patients who are in my ICU now — people whose families cannot be with them when they’re taking their last breath.”

According to the CDC, Black and Hispanic individuals are 2.8 times more likely to die from COVID-19. Over 375,000 Americans, including many people of color, have already died as a result of the disease. “So make the right choice — roll up your sleeve and get the shot,” Dr. Simmonds urges.

Staying Safe Until a Vaccine Is Available

Basic steps like social distancing and wearing a mask are the best ways to protect yourself and everyone around you until it’s your turn to be vaccinated and the majority of our population has received the vaccine. Also, continue to practice the safety steps you already know, like:
• Avoiding touching your eyes, nose and mouth
• Cleaning and disinfecting frequently touched surfaces daily
• Getting your annual flu shot
• Staying at least 6 feet apart from anyone outside your household
• Washing your hands often with soap and water or using sanitizer often
• Wearing a mask that covers your mouth and nose when around others

We’re Here for You and Your Family

As more information on COVID-19 treatments becomes available, we’ll keep you informed. Stay in the loop by visiting the  Coronavirus Resource Hub.