Key takeaways:

  • An emergency use authorization (EUA) allows for vaccines, tests, and treatments to be used during a public health emergency based on best available evidence — without being fully FDA-approved.
  • The Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines have been issued EUAs. Pfizer and Moderna have started the process for full approval.
  • Pfizer’s COVID-19 vaccine may be fully approved by Labor Day.
  • Moderna recently began filing their Biologics License Application (BLA) with the FDA, requesting Priority Review to expedite the approval timeline.
  • Johnson & Johnson has said that they expect to apply for full approval later this year.

With just under half of the U.S. population fully vaccinated against COVID-19 and the highly-contagious Delta variant now making up more than 80% of current cases, vaccination efforts are a priority as infection numbers rise.

Although we’re seeing breakthrough COVID-19 cases in vaccinated people, the vast majority being hospitalized and dying from the disease are unvaccinated. That means that the vaccines are doing their job by preventing serious illness, but you still might catch and spread the virus.

While there are people who are unable to get vaccinated — like young children and those with a history of severe allergic reactions to a vaccine ingredient — others haven’t felt confident with the emergency use authorization (EUA) process and have been holding out for the FDA’s full stamp of approval. Thankfully, they may not be waiting much longer.

Update: August 9, 2021

Pfizer COVID-19 vaccine approval expected early September 

Last month, Pfizer announced that the FDA granted Priority Review designation for their COVID-19 vaccine Biologics License Application (BLA) — the application to fully approve the vaccine. This means that the application is prioritized, shortening the FDA’s review time from 10 months to 6 months.

At the time of the announcement, the FDA’s decision wasn’t expected until January 2022. However, it was recently reported that the FDA is now targeting approval in early September — with an unofficial deadline of September 6.

As of yet, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) hasn’t posted a meeting date for when they’ll be discussing Pfizer’s application.

Moderna begins filing for FDA approval of COVID-19 vaccine

In early June, Moderna announced that they had started submitting their COVID-19 vaccine BLA to the FDA. Like Pfizer, they’ve requested Priority Review designation.

Since Moderna’s vaccine was granted the Fast Track designation last year, they’re able to submit sections of the application as they are completed — called a rolling review — rather than all at once. This helps lower the application’s review time.

Once the BLA submission is complete, the FDA will notify them when it’s been accepted for review.

Johnson & Johnson expected to file for approval later in 2021

The Johnson & Johnson (Janssen) COVID-19 vaccine was authorized more recently than the Pfizer and Moderna vaccines, so the company has yet to begin the BLA submission process. However, in late April, they said that they plan to file their application later this year.

The bottom line

The best way to protect yourself and those around you from serious illness is to get vaccinated against COVID-19. And if you’ve been hesitant to get the shot until it’s fully approved, you may not be waiting much longer.