FDA set to decide on Novavax COVID-19 vaccine
ATLANTA - Eighteen months after launching the Novavax COVID-19 vaccine trial at Morehouse School of Medicine, with 173 volunteers, 66% of them African American, Dr. Lilly Immergluck got word Tuesday an FDA advisory panel had voted nearly unanimously to recommend the agency authorize the Novavax vaccine.
She was thrilled.
"I did my happy dance with my team," Immergluck laughs. "Yeah, we were so grateful."
If it is green-lighted by the FDA, Novavax would be the fourth COVID-19 vaccine authorized by the FDA for emergency use in the US.
It uses different technology than the mRNA vaccines from Pfizer and Moderna most Americans have received.
NOVAVAX HOPES TO WIN OVER AMERICANS
Novavax is protein-based vaccine, developed with the same technology used to make vaccines for Hepatitis B and shingles.
Dr. Immergluck says it delivers tiny pieces of the spike protein located on the surface of the coronavirus to help the body's immune system recognize and respond to the virus.
In the study, the Novavax vaccine was 90% effective at prevent symptomatic COVID-19, although it was tested before the highly contagious Omicron variant surfaced.
"There is no live virus, there isn't even a whole virus, killed or otherwise that is being injected," Immergluck says. "It is really the spike protein. But the way I think about it, is, if your body can mount an immune response against the spike protein, then when you see the real deal, which is covered by spike protein, the virus is covered by spike protein, then it should do what it needs to do to keep you from getting infected."
About two-thirds of Americans are fully vaccinated, but tens of millions have not received a single dose.
Dr. Immergluck says she's hopeful the Novavax vaccine may sway some holdouts.
"But, honestly, (get) any of the vaccines that are out there," she says. "The mRNA technology, we've got millions of people that have been vaccinated with it. It really does stand up to say about its safety profile. So, I don't want to dissuade people from getting vaccinated against COVID, because that's the most important thing."