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Yes, the Pfizer COVID-19 vaccine has received FDA approval, but the others haven't yet

Pfizer's COVID-19 vaccine received FDA approval on Aug. 23. Moderna and Johnson & Johnson’s COVID-19 vaccines have received emergency use authorization from the FDA.
Credit: AP
FILE - In this March 2, 2021, file photo, pharmacy technician Hollie Maloney loads a syringe with Pfizer's COVID-19 vaccine at the Portland Expo in Portland, Maine. The U.S. gave full approval to Pfizer's COVID-19 vaccine on Monday, Aug. 23, 2021. (AP Photo/Robert F. Bukaty, File)

Editor's Note: This story has been updated to reflect the FDA's approval of the Pfizer-BioNTech COVID-19 vaccine on Aug. 23, 2021.

Drug companies like Pfizer, Moderna and Johnson & Johnson rushed to create COVID-19 vaccines to combat the disease as it spread rapidly across the United States amid the coronavirus pandemic, and they were first administered to the public in December 2020. Now, more than 51.5 percent of Americans have been fully vaccinated against COVID-19 as of Aug. 22, 2021, according to the CDC.

Many people online are still wondering what is the difference between an emergency use authorization (EUA) and FDA approval when it comes to the COVID-19 vaccines. 

THE QUESTION

Has the Pfizer-BioNTech COVID-19 vaccine received FDA approval? 

THE SOURCES

  • U.S. Food and Drug Administration (FDA)
  • U.S. Centers for Disease Control and Prevention (CDC)
  • Pfizer and BioNTech

THE ANSWER

This is true.

Yes, the Pfizer-BioNTech COVID-19 vaccine received FDA approval on Aug. 23, 2021. 

WHAT WE FOUND

The FDA approved the Pfizer-BioNTech COVID-19 vaccine on Aug. 23, 2021 — it is now the first COVID-19 vaccine to receive approval from the FDA. 

According to the FDA, the vaccine will now be marketed as Comirnaty and used for the prevention of COVID-19 disease in individuals who are 16 years old and older. 

"The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

The Pfizer-BioNTech COVID-19 vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals, the FDA said in a press release.

On Dec. 11, 2020, the FDA granted Pfizer-BioNTech’s COVID-19 vaccine an emergency use authorization. Then, on July 16, Pfizer announced the FDA had formally accepted its Biologics License Application (BLA) requesting approval of the company's COVID-19 vaccine for people 16 years old and older. The FDA granted the application priority review. At that time, the FDA said the agency had planned to complete the review far in advance of the Prescription Drug User Fee (PDUFA) goal date of Jan. 2022.

The CDC’s Advisory Committee on Immunization Practices will meet on Aug. 30 to discuss its updated recommendation for the Pfizer-BioNTech COVID-19 vaccine.

THE QUESTION 

Have the Moderna and Johnson & Johnson COVID-19 vaccines received FDA approval? 

THE SOURCES

  • U.S. Food and Drug Administration (FDA)
  • Moderna
  • Johnson & Johnson

THE ANSWER

This is false.

No, Moderna and Johnson & Johnson’s COVID-19 vaccines have not received FDA approval, however, they were granted emergency use authorization (EUA). 

WHAT WE FOUND

According to the FDA, “An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.”

The FDA authorized Moderna’s COVID-19 vaccine for emergency use on Dec. 18, 2020.

Johnson & Johnson received emergency use authorization from the FDA for its single-dose COVID-19 vaccine on Feb. 27, 2021. This was later amended on April 23 to include information about a very rare and serious type of blood clot in people who receive the vaccine. According to the FDA, the EUA allows the Johnson & Johnson COVID-19 vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

The FDA further explains what happens under an EUA on its website

“Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.

Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.”

On May 6, Moderna announced that the company planned to initiate a rolling submission for a Biologics License Application, or BLA, for its COVID-19 vaccine in the U.S.

The FDA amended the Moderna COVID-19 vaccine EUA on Aug. 12 to allow for an additional dose to be given to certain immunocompromised individuals. The emergency use authorization allows the Moderna COVID-19 vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

Johnson & Johnson told VERIFY through email that the company plans to file for a BLA with the FDA later in 2021. 

More from VERIFY: Yes, delta variant symptoms are slightly different than original COVID-19 strain symptoms

   

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