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Pfizer Seeks FDA Full Approval for COVID Vaccine. What Does That Mean?

Illustration of scientists holding a vaccine syringe.

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Key Takeaways

  • Pfizer/BioNTech is applying for full FDA approval for their COVID-19 vaccines. 
  • Emergency use authorization is only granted to drugs and vaccines that are needed in a public health emergency. 
  • Full approval would grant Pfizer/BioNTech permission to market their vaccines directly to the American public.

At the beginning of May, Pfizer/BioNTech submitted an application to the Food and Drug Administration (FDA), seeking full approval for their COVID-19 vaccines. Moderna is expected to follow suit.

Currently, Pfizer, Moderna, and Johnson & Johnson are allowed to distribute vaccines to the public under emergency use authorization (EUA)–a form of approval used to facilitate the availability of drugs and vaccines during public health emergencies.

William Schaffner, MD, medical director of the National Foundation for Infectious Diseases, tells Verywell that the FDA full approval process is more rigorous compared to an EUA. “It involves reviewing all of the data regarding the effectiveness of the vaccine, its safety, many aspects of its manufacturing process, including inspections of the facilities, where it’s manufactured, and also some longer-term data on safety,” Schaffner says. 

But don't expect full approval anytime soon. The full approval process can take months, Sri Banerjee, MD, PhD, MPH, MS, CPH, MCHES, epidemiologist and public health faculty member at Walden University, tells Verywell. “Once the FDA receives all parts of an application, it sets a target date for a regulatory decision, typically about ten months later,” Banerjee says.

Because of the pandemic, the initial authorization of the COVID-19 vaccines was prioritized. “In the case of the COVID-19 vaccine, since priority review was approved, this process only took six months," he adds.

More than 290 million doses have already been administered and 40% of the total U.S. population is fully vaccinated.

The Difference Between an EUA and Full Approval

Banerjee says that under an EUA, the FDA will only allow the use of unapproved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases.

“A vaccine generally needs to have FDA approval before the public can receive it, but because COVID-19 is considered a public health emergency, vaccine manufacturers chose to submit a request for an EUA,” Banerjee explains. 

In order for these vaccines to have received an EUA, Banerjee says they already underwent a rigorous process. “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,” Banerjee says. 

He adds that the FDA issued an EUA based on the safety and efficacy data from a large, phase three clinical trial, underscoring the safety and effectiveness of the currently authorized COVID-19 vaccines.

“The FDA’s scientific and regulatory advice to vaccine developers, as well as the FDA’s evaluation to determine the safety and effectiveness of vaccines, are among the most robust in the world," Banerjee says.

What Can Be Done Differently Under Full Approval?

Because the Pfizer and Moderna vaccines were only given EUA, they cannot be used once COVID-19 is no longer deemed a public health emergency. Full approval will allow vaccine companies to keep their shots on the market post-pandemic.

Full approval would also mean the vaccine powerhouses are free to market the shots directly at the American public, which isn't currently allowed under an EUA. This will allow companies like Pfizer and Moderna to air advertisements and commercials promoting vaccination.

With full approval, experts expect more employers and businesses to mandate vaccinations for employees and members. “For example, there’s a long list of colleges, Vanderbilt included, that has informed the students that if you want to come back and attend this fall, you have to be vaccinated,” Schaffner says.

“A full approval would have more leverage in court than just an EUA,” Banerjee adds. 

What This Means For You

If you're not yet vaccinated, or want to help someone else get their shot, you can find available COVID-19 vaccine appointments near you on VaccineFinder.org. If you want to help encourage hesitant people in your life to get vaccinated, our COVID-19 vaccine Healthy Conversation Coach can guide you through what to say—and what not to say—to someone still on the fence.

It May Help Curb Vaccine Skepticism

When COVID-19 vaccines were first approved by the FDA, the approval was met with some skepticism from the public out of fear that the vaccines were approved “too fast.”

Schaffner says that a full FDA approval could curb the hesitancy witnessed throughout vaccine rollout. “I think it would provide a degree of psychological comfort and reassurance to some hesitant people that yes, indeed, they’ve finally gone through the whole process,” Schaffner says. “And I think it might persuade some people to roll up their sleeves and get vaccinated.” 

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

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  1. National Public Radio. How Is The COVID-19 Vaccination Campaign Going In Your State? Updated May 26, 2021.

  2. Food and Drug Administration. Emergency Use Authorization for Vaccines Explained. Updated November 20, 2020.