What is the difference between an emergency use authorization and an approval?

key takeaways

  • The FDA wants to see safety and efficacy data before approving any new vaccine.
  • An external advisory committee reviews data for each new vaccine.
  • Companies with emergency use authorizations must continue clinical trials. This ensures long-term information on safety and efficacy.
  • The FDA expects that companies with emergency use authorizations will also apply for standard non-emergency approvals.

Less than a year after the pandemic began, the U.S. Food and Drug Administration (FDA) issued emergency use authorizations (EUAs) for three COVID-19 vaccines. These include:

  • Pfizer – BioNTech Vaccine, 11 Dec 2020
  • Moderna vaccine, 18 Dec 2020
  • Johnson & Johnson Vaccines, February 27, 2021

EUA makes these vaccines available to the public immediately.

On August 23, 2021, the FDA fully approved the Pfizer-BioNTech COVID-19 vaccine for use in people 16 years of age and older. This makes it the first FDA-approved COVID-19 vaccine. After approval, the vaccine was marketed under the name Comirnaty.

The Pfizer vaccine is also available for children 5 to 15 years old under the EUA.

On January 31, 2022, the FDA expanded the full approval of Moderna’s COVID-19 vaccine for use in people 18 years of age and older. It will be sold under the name Spikevax.

This article looks at the difference between emergency use authorization and full FDA approval.

FDA authorizes Pfizer as first COVID-19 vaccine

How is EUA different from approval?

The EUA program was established in 2004 following the terrorist attacks of September 11, 2001. The plan establishes new rules for the use of certain medical products during a public health emergency. Under this program:

  • FDA can authorize use of unapproved medical products
  • FDA Can Authorize Approved Medical Products for Unapproved Uses

COVID-19 was declared a public health emergency in the United States on January 31, 2020.

COVID-19 Vaccines: Stay up to date on vaccines that are available, who can get them, and how safe they are.

Joshua Sharfstein is the former chief deputy commissioner of the FDA. “When an emergency is declared, the FDA can judge whether it is worth releasing certain products for use, even without all the evidence to fully demonstrate their efficacy and safety,” he said.

Sharfstein is now associate dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland.

Sharfstein said EUAs are also used in drugs or vaccines to treat or prevent anthrax, Ebola and Middle East Respiratory Syndrome (MERS).

CDC advisory panel says mild side effects expected from COVID-19 vaccine

EUA application requirements

Manufacturers often have to obtain formal approval for new vaccines. To begin the process, they submitted a Biolicense Application (BLA).

However, during a public health emergency, they can apply for an EUA if no other vaccine is available. The FDA must decide whether the known and potential benefits of the vaccine outweigh the risks.

“[For an EUA] Data is often less than what is available [a BLA]said LJ Tan, Chief Strategy Officer, Immunization Action Coalition (IAC), an advocacy group working to increase immunization rates in the U.S.

“But that’s not to say that clinical trials are compromised by design,” he said, “it’s just that the EUA was issued earlier than the license, so we haven’t accumulated that much data for the trial.”

According to FDA regulations, products submitted for EUA must still undergo rigorous testing. For COVID-19 vaccines, the FDA tells vaccine makers they need to:

  • Provide data from vaccine safety studies
  • Follow-up for at least two months after clinical trial completion

According to the guidance, the FDA can grant an EUA in the following situations:

  • This product can reasonably prevent, diagnose or treat serious or life-threatening disease or condition caused by SARS-CoV-2.
  • Known and potential benefits outweigh known and potential risks.
  • There are no suitable, approved and available alternatives.

The FDA also requires vaccine makers to develop plans to follow up on vaccine safety. Under these programs, manufacturers must investigate the following reports of people vaccinated under the EUA:

  • death toll
  • hospitalized
  • Other serious or major adverse events

Can pregnant and breastfeeding women get the COVID-19 vaccine?

Peter Marks, MD, Ph.D., is director of the FDA’s Center for Biologics Evaluation and Research. “Disclosure and clarity on the circumstances under which emergency use authorization for a COVID-19 vaccine is appropriate is critical to building public confidence and ensuring that a COVID-19 vaccine is available once it is available,” he said in a statement.

“In addition to outlining our expectations for vaccine sponsors, we hope that the agency’s guidance on COVID-19 vaccines will help the public understand our science-based decision-making process to ensure vaccine quality, safety, and safety of any licensed or approved vaccine. and effectiveness,” he said.

The FDA also wants manufacturers with EUAs to continue clinical trials. Ultimately, every manufacturer needs to apply for a BLA.

Once the public health emergency declaration ends, the EUA will no longer be in effect. That means the vaccine needs to be fully approved for continued use.

what does this mean to you

During a public health emergency, the FDA allows vaccine manufacturers to apply for emergency use authorization. This could speed up the time it takes to get a vaccine approved.

The information in this article is current as of the date listed, which means that you may have updated information as you read this article. For the latest updates on COVID-19, visit our Coronavirus news page.