Novavax’s Covid-19 Vaccine Backed by FDA Advisers
Vaccine advisory committee finds in an overwhelming vote that vaccine’s benefits outweigh risks
Vaccine experts advising the Food and Drug Administration endorsed Novavax Inc.’s Covid-19 vaccine, voting overwhelmingly that the shot’s benefits outweighed its risks.
The outside panel’s 21-0 vote, with one abstention, on Tuesday moves the shot one step closer to becoming available in the U.S.
The FDA must next make a decision on authorizing the vaccine, after months of manufacturing-related delays and an agency review that found the shots effective but raised a safety concern.
An FDA decision could take weeks. FDA staff said, in their review of Novavax’s application, that the agency must sign off on the company’s latest manufacturing processes.
If the agency authorizes the vaccine, the Centers for Disease Control and Prevention would then decide whether to recommend the vaccine’s use, before the shots would become widely available.
The shot would be the first available using a more traditional, protein-based vaccine technology, found in hepatitis B and shingles vaccines, than the relatively new messenger RNA Covid-19 shots in wide use.
Advisers said Novavax’s shot performed akin to vaccines already authorized. “If we’re going to use the same criteria that we did then, it’s not that difficult of a decision now,” said Dr. Eric Rubin, editor in chief of the New England Journal of Medicine.
Novavax Chief Executive Stanley Erck said the panel’s endorsement “acknowledges the strength of our data and the importance of a protein-based Covid-19 vaccine.”
Novavax has said its shot would appeal to people reluctant to receive the vaccines made by either Pfizer Inc. and partner BioNTech SE or by Moderna Inc., which are each based on the gene-based technology known as messenger RNA.
Members of the Vaccines and Related Biological Products Advisory Committee said it would be helpful to offer choices beyond the current shots, including the widely used mRNA vaccines from Pfizer and BioNTech and from Moderna.
The advisers expressed skepticism, however, that those who avoided messenger RNA vaccines would adopt Novavax’s protein-based shot but said it would be good to offer more choices.
Overall, the use of Covid-19 vaccines and boosters has slowed in the U.S., as many people eligible for the shots have received them and tire of getting additional doses. Roughly 67% of the U.S. population is fully vaccinated against Covid-19, according to the CDC. Less than half the population has received one booster.
During its all-day meeting, the committee considered clinical trial data from the company as well as the FDA staff’s review.
Agency staff told the outside advisers that the shot was 90% effective against Covid-19 in its pivotal trial but noted six concerning cases of heart-inflammation conditions in vaccine recipients.
Novavax, of Gaithersburg, Md., pushed back on those concerns in its presentation, saying the myocarditis and pericarditis cases were consistent with what would be expected in the general population.
Several of the committee members said they supported adding a warning about myocarditis, as is done for the mRNA vaccines currently.
“We need to understand the mechanism here, because this infection and the vaccines against it are going to be with us for the foreseeable future,” Dr. Bruce Gellin, chief of global public health strategy for the Rockefeller Foundation’s Pandemic Prevention Institute.
He abstained from the committee’s vote, but afterward said he was a “conditional yes.”
The pivotal trial for the Novavax vaccine took place before the Omicron variant emerged. Studies have found Omicron has been better able to elude authorized vaccines, but the impact on Novavax’s hasn’t been determined, said Dr. Filip Dubovsky, the company’s chief medical officer. He said studies are ongoing.
The company’s Covid-19 vaccine would be the first authorized in the U.S. with a traditional protein-based platform.
It sends a version of the coronavirus spike protein to stimulate the body’s immune response. That is different from the market-dominating Pfizer-BioNTech and Moderna vaccines, which deliver mRNA to instruct the body to assemble a harmless version of the coronavirus spike protein, which then triggers the immune system to mobilize defenses.
Johnson & Johnson’s Covid-19 vaccine uses a modified version of an adenovirus, the virus behind many common colds, to deliver genetic instructions to cells.
Novavax has said it regularly gets calls and emails from people awaiting its vaccine, and some experts have voiced hope that the shot could win over unvaccinated skeptics of mRNA technology.
Kayb Joseph, a 47-year-old Chattanooga, Tenn., resident, said she has checked every two weeks for news on Novavax’s vaccine and would drive to the company’s Maryland headquarters to get it if needed. She prefers its protein-based platform.
“I just don’t believe in being somebody’s R&D,” she said. “Novavax is still just the first version, but to me it is the second version of traditional technology.”