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Article Type: Blog

Coronavirus Vaccine: EUA vs. FDA Approval

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COVID-19 numbers continue to rise across the United States and other parts of the world, creating even more urgency for a vaccine to be available to the public.  

Although creating a new vaccine can sometimes take years, many pharmaceutical companies are quickly advancing in research and clinical trials. This means it’s possible a coronavirus vaccine could be available in the coming months, but it likely will not immediately carry approval by the Food and Drug Administration (FDA).

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. They’re calling this mission “Operation Warp Speed” and have a goal to produce and deliver 300 million doses. They are hopeful to be able to create safe and effective vaccines with the initial doses available by January 2021.

As of October 2020, four vaccines have started large-scale clinical trials in the United States, also known as Phase 3, and three out of the four would require two-shot doses for anyone wishing to be vaccinated. 

The Clinical Trial Process

If 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, where many trials stand at this point, 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. 

This 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.

From the information currently available, the vaccine will likely be EUA approved, but may not initially 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 will only issue an EUA if a vaccine has demonstrated clear and compelling effectiveness in a large Phase 3 clinical trial.

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.

Staying Safe Until a Vaccine Is Available 

Until a vaccine is widely available, basic steps like social distancing and wearing a mask are the best ways to protect yourself and everyone around you. 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

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