Novavax COVID vaccine trial participants left battling a tough decision after FDA submission delayed

Novavax recently announced it will delay their submissions of its vaccine to the FDA for emergency use authorization.

Dr. Matthew Hong with Wake Research says it’s a tough place to be and he understands the frustration. However, he says patients and researchers are both waiting on Novavax’s next move and there’s no telling when that will be.

Greg Carrero is one of the thousands stuck battling the tough decision.

"Do I leave the trial and go get another vaccine, so I'm not stranded in the middle?" Carrero, a Novavax Trial Participant, said.

Carrero says he has a CDC vaccine card that says "Trial Participant" but, he’s still considered unvaccinated when he tries to leave the country or participate in activities that require an FDA-approved vaccine.

"Can I travel to Europe for example? EMA doesn’t recognize the Novavax vaccine at all!" Carrero said.

Dr. Hong says everyone in a Novavax trial is already fully vaccinated. The problem is that it’s not approved by the FDA. And some participants are already dropping out.

"A few more than we’ve seen with the other trials but, usually, that’s what you find. People are just dropping out," Dr. Hong said.

Participants can chose to drop out but, he does not recommend mixing vaccines. He says there’s a chance for enhanced reaction. That's Carrero’s biggest concern.

"There’s no health organization that recommends people mix and match vaccines, which is what any trial participant would do if they leave and go get an approved vaccine. I’m a little scared to mess with science at the moment," Carrero said.

Dr. Hong says right now, the earliest we can expect to hear anything from Novavax is October.