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What Will Full FDA Approval Change for COVID-19 Vaccines?

Someone with gloves filling up a vaccine syringe.

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Key Takeaways

  • A full FDA approval takes longer than an EUA because more data needs to be processed and reviewed.
  • Healthcare providers would be able to use approved COVID-19 vaccines for off-label use.
  • Booster shots are not yet included in Pfizer or Moderna's full approval application.

As the Delta variant surges across the country, the pressure for the Food and Drug Administration (FDA) to grant Pfizer's COVID-19 vaccine full approval is on.

Last month, the FDA formally accepted Pfizer and BioNTech’s Biologics License Application (BLA) for their COVID-19 vaccine. Experts say approval for Pfizer's vaccine could come in the next few months.

All three available vaccines currently have emergency use authorization (EUA) from the FDA.

Moderna has already initiated the rolling submission of their BLA in June and is awaiting formal acceptance from the FDA. Meanwhile, Johnson & Johnson has yet to submit their application but plans to do so within the year.

Verywell spoke to experts about what full approval could mean for vaccinations and doctors as they encourage their patients to get the shot.

Why Hasn’t the FDA Approved the Vaccines?

The three COVID-19 vaccines currently approved for use were granted an emergency use authorizations (EUA) several weeks after their respective manufacturing companies submitted an application. However, applying for a full license takes much longer.

To gain full approval, companies need to fulfill more requirements and provide the FDA a greater amount of data to review.

An EUA application requires about two months of follow-up with at least half of the vaccine recipients included in phase 3 clinical trials. In contrast, an application for full approval needs at least six months of follow-up data.

“There is a lot more data evaluated and summarized for the full approval versus the EUA, and this is one of the primary reasons that the process takes longer,” Iahn Gonsenhauser, MD, MBA, chief quality and patient safety officer at The Ohio State Wexner Medical Center, tells Verywell. “An additional major requirement of FDA approval, not required for EUA, is the rigor of the review of manufacturing practices including facilities and operations inspections. These are huge multinational operations and this also takes time.”

To speed things along, the FDA granted priority review for Pfizer’s application for a full license. They are required to make their decision by January 2022, but the FDA will likely complete their review far before this deadline.

“There are no shortcuts in the current process for COVID vaccine approval,” Gonsenhauser says. “However, this process is being expedited by simply redirecting far more resources than would be typically directed, as this is a priority above just about all other applications for approval.”

What Can Doctors Do Differently Once Vaccines Are Fully Approved?

When a product is fully approved by the FDA, patients can be assured that its recommendation is grounded in large amounts of scientific data.

“Full approval allows physicians to prescribe a product and means that the FDA has reviewed all the additional safety, manufacturing, and packaging procedures,” Chris Beyrer, MD, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, tells Verywell. “Fully approved products come with the FDA package insert listing all contraindications, warnings, and safety information. The package insert really is the key document for providers to discuss a product with patients.”

Although healthcare providers can administer vaccines with either an EUA or a full license, they are not used in exactly the same way.

“The biggest difference between administering a drug under EUA versus under full FDA approval is that under EUA, the indications for use must be followed exactly,” Gonsenhauser says. “No off-label use is allowed. This limits who, when, and why vaccines may be elected to be used.” 

When a vaccine operates under EUA, there are specific conditions for use that healthcare providers must abide by. A fully approved vaccine may be used “off-label,” or in circumstances that are slightly different from what is outlined in its license. Healthcare providers may prescribe it to their patients as they see fit.

“However, in the case of the COVID vaccines, this likely does not have substantial ramifications due to the fact that essentially everyone should be getting vaccinated with the exception of young children at this time,” Gonsenhauser says.

Will COVID-19 Booster Shots Be Included?

Last Thursday, the FDA amended the EUA of both Pfizer-BioNTech and Moderna COVID-19 vaccines to authorize a third dose for immunocompromised people.

They reiterated that people who are not immunocompromised are adequately protected and do not need an additional dose at the moment.

However, booster shots are not yet included in these companies’ applications for full approval.

“The boosters are not part of the full approval application at this point,” Beyrer says. “The company can request an approved product, like a 2-dose vaccine, be amended to include a booster, but that is an additional filing with supportive data to the FDA.”

Pfizer’s ongoing application only applies to individuals ages 16 and above. Although their EUA was expanded last May to authorize the use in adolescents ages 12 to 15, the application does not cover this age group yet.

The company will have to submit a supplemental application once they have six months' worth of follow-up data. Similarly, they will have to provide additional data regarding their booster shot for it to be covered by the license.

“The studies on booster shots are just enrolling or enrolled, so [that] will take a few weeks to months to find out if there is clinical benefit,” Onyema Ogbuagu, MBBCh, Yale Medicine infectious diseases specialist and principal investigator for Pfizer trials held at Yale School of Medicine, tells Verywell. “No doubt that it will boost antibody levels, [the] issue is to see if they confer clinical benefits such as preventing COVID-19.”

Overall, experts are hopeful that full approval for the COVID-19 vaccines can potentially increase vaccine confidence.

“Full approval of COVID-19 vaccines will add an extra layer of ‘perceived legitimacy’ to vaccine skeptics that the vaccines have met the FDA’s safety and efficacy bar,” Ogbuagu says. “This will also inform and strengthen the basis for more vaccine mandates or policies—businesses, schools or universities, offices—that should also improve vaccine uptake.”

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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