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No, the COVID-19 vaccines haven’t received FDA approval yet

Pfizer, Moderna and Johnson & Johnson’s COVID-19 vaccines have all received emergency use authorization from the FDA.
Credit: KENS 5

The COVID-19 pandemic has killed more than 568,000 people in the United States as of May 12. Drug companies like Pfizer, Moderna and Johnson & Johnson rushed to create vaccines to combat the disease, and the first vaccines were administered to the public in December 2020.  

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

THE QUESTION

Have the COVID-19 vaccines received FDA approval? 

THE SOURCES

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

THE ANSWER

This is false.

No, none of the COVID-19 vaccines have received FDA approval yet, however, Pfizer, Moderna and Johnson & Johnson were all 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.”

On December 11, 2020, the FDA granted Pfizer-BioNTech’s COVID-19 vaccine an emergency use authorization. A week later, the FDA authorized Moderna’s COVID-19 vaccine for emergency use on Dec. 18, 2020. 

Then, on Feb. 27, 2021, Johnson & Johnson received emergency use authorization from the FDA for its single-dose COVID-19 vaccine. 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.

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 plans to initiate a rolling submission for a Biologics License Application, or BLA, for its COVID-19 vaccine in the U.S. this month. 

Meanwhile, Pfizer and BioNTech announced on May 7 that the companies had initiated a BLA with the FDA for the approval of their COVID-19 vaccine for people over the age of 16.

“Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review,” the companies said in a press release. 

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, kids should get the COVID-19 vaccine

VERIFY
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