How Soon Will the FDA Fully Approve Moderna and J&J Vaccines?

Dr. Anthony Fauci said Moderna and Johnson & Johnson are no more than months away from getting full FDA approval for their COVID-19 vaccines.

Moderna and Johnson & Johnson’s COVID-19 vaccines may be months away from full FDA approval. Michael Ciaglo/Getty Images

The U.S. Food and Drug Administration on Monday approved the first COVID-19 vaccine, made by Pfizer and BioNTech, for people ages 16 and older in the U.S.┬áThe full approval came eight months after the FDA authorized the Pfizer-BioNTech vaccine for emergency use in adults and marked a crucial point in the world’s battle against the coronavirus pandemic.

Until Monday, the FDA had authorized the emergency use of three COVID-19 vaccines: Pfizer, Moderna and Johnson & Johnson. Now that Pfizer is past the finish line, the question has to be asked: How far away are we from the full FDA clearance for Moderna and J&J?

“I don’t think it’s too far way,” Dr. Anthony Fauci, President Biden’s chief medical advisor, said on CBS This Morning on Tuesday. “Both of those products were a bit behind in the initiation of their EUAs…I don’t think there’s anything different about the process. It’s just that they are submitting their material a bit later.”

Fauci added that he expects the FDA to fully authorize the Moderna and J&J shots in “a matter of months or so, but not more than that.”

Moderna has been submitting data for its biologics license application, or BLA, a required process to get the FDA’s full vaccine approval, since June. The company said on Wednesday it had completed the submission. It took the FDA nearly four months to approve Pfizer’s application.

Moderna’s vaccine is currently authorized for emergency use in people ages 18 and older. The company also has a pending application at the FDA to expand the EUA to people between ages 12 and 18.

Similar to the Pfizer-BioNTech vaccine, Moderna shots are developed based on the novel mRNA technology and require two doses. Both companies have been testing the efficacy of a third booster shot, especially against the delta variant.

Also on Wednesday, J&J released encouraging results on its own booster shot. The original vaccine, developed using the same platform that produced J&J’s Ebola vaccine, requires only one dose.

Two Phase 2 studies conducted in the U.S. and Europe show that people who received a J&J booster six to eight months after their first injection saw antibodies increase nine-fold higher than 28 days after the first shot, Johnson & Johnson said on Wednesday. About 2,000 people participated in the two studies.

“We have established that a single shot of our COVID-19 vaccine generates strong and robust immune responses that are durable and persistent through eight months,” Dr. Mathai Mammen, global head of research and development for J&J’s Janssen, said in a statement. “With these new data, we also see that a booster dose of the Johnson & Johnson COVID-19 vaccine further increases antibody responses among study participants who had previously received our vaccine.”

How Soon Will the FDA Fully Approve Moderna and J&J Vaccines?