Why haven't Moderna and J&J COVID vaccines received full FDA approval?

ATLANTA — On Monday, the Food and Drug Administration gave full approval to Pfizer's COVID-19 vaccine. 

However, while the decision marks an important milestone in encouraging the public to get vaccinated, many are likely wondering, what about the Moderna and J&J vaccines? Why are those not approved yet?

Essentially, the simple answer is these things take time.

The companies all applied for FDA approval at different times. Pfizer-BioNTech applied for approval back in May, while Moderna applied in June. J&J said they plan to file for full approval "later in 2021." 

As a result, not all vaccines are at the same stage in the approval process, and one's length of time for approval doesn't always mean the same for others.  

The FDA did previously grant Emergency Use Authorization for all three vaccines after a series of clinical trials and said they continue to monitor the vaccines' safety.

For months, while operating under the Emergency Use Authorization, vaccine manufacturers have been collecting data. 

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And, as Dr. Grace Gowda of the University of Georgia’s College of Pharmacy explained to 11Alive's Jerry Carnes, the FDA needs to review all of that data before granting full approval carefully.

“We’re talking millions of pages,” Dr. Gowda explained. “It’s pretty much all hands on deck, a whole bunch of people to review millions of pages of documents. The FDA review process is the most robust in the world.”

Even before granting the Emergency Use Authorization, the FDA had to conduct a scientific evaluation to "assure the public and medical community that the vaccines meet the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality.”

Dr. Gowda says the data review process alone typically takes the FDA as much as two years.