August 26, 2021

There’s been some updates regarding COVID-19 vaccines in the last week. Here’s the latest.

First, the FDA granted full approval to Pfizer’s COVID-19 vaccine — which will be marketed as Comirnaty. This applies to all Americans ages 16 and older, however, the vaccine is still available under Emergency Use Authorization for patients between the ages 12 and 15.

The FDA approval came the study with data around 12,000 patients that used the vaccine for six or more months. The FDA weighed the efficacy of the vaccine vs. the safety parameters.

What about the Moderna vaccine?

The Moderna vaccine does not yet have full FDA approval. However, Moderna did apply for approval in June, so hopefully that data will be coming soon. The Moderna vaccine is still available under EUA.

And Johnson & Johnson?

Like Moderna, the Johnson & Johnson vaccine has not been granted full FDA approval yet. Johnson & Johnson has yet to apply for approval, but there is belief that is happening soon.

Does this change with boosters?

Right now, nothing has changed in regards to getting the booster shots. Last week, the CDC announced recommendations of a third booster shot for patients who received both doses of either the Pfizer or Moderna vaccines. The CDC recommended booster shots at least eight months after the second dose. The Johnson & Johnson vaccine, a one-dose shot, is still being studied for a second booster shot.

That’s what employers are asking us. If you have a question you want to be answered, email us at askapex@apexbg.com.

Erin L. Albert

Authored By

Erin L. Albert, MBA, PharmD, JD, PAHM

Kinetiq Health Pharmacy Benefit Practice Leader
Meet Erin L.