In the Maryland suburbs northwest of Washington D.C., only 21 miles separates the Food and Drug Administration from Novavax. But the road to approval for the biotech’s COVID-19 vaccine has been an arduous trek full of potholes, detours and wrong turns.
Finally on Tuesday, Novavax found itself closing in on its destination as an FDA panel of independent experts voted 21-0, with one abstention, to recommend its vaccine for authorization for those 18 and older.
The endorsement leaves the fate of the shot in the hands of the FDA, which could sign off on it as early as this week. Before the shot can be supplied to pharmacies, it would have to also pass muster with the CDC.
With a nod, Novavax’s shot would become the fourth sanctioned immunization in the United States for use against the virus.
Demand for COVID vaccines is down in the U.S. but Novavax’s shot—which was developed with protein-based technology, much like traditional flu shots—might be an attractive alternative for those who have been hesitant to try the mRNA vaccines produced by Pfizer and Moderna. In fact, that has been Novavax's own approach to marketing its program.
Novavax has traveled a painstaking path to a potential approval. Boosted by a $1.6 billion grant from the government, Novavax was hailed as a rags-to-riches success story early in the pandemic as it hit development milestones for its vaccine.
Showing 90% efficacy in trials and 100% success in preventing serious disease, the shot appeared on the fast track to an FDA green light, prompting the company to promise delivery of the shot by May of 2021.
But then a host of regulatory and manufacturing problems kept it on the sidelines as Novavax—without a product on the market—showed its inexperience.
Early this year, Novavax got an approval from the European Union for its jab and began fulfilling its pledge to supply the bloc with 100 million doses of the two-shot vaccine.
The approval and Tuesday’s AdComm recommendation came despite a lack of evidence that the jab is effective in preventing infection from the omicron variant.
Novavax’s chief medical officer Filip Dubovsky told the panel on Tuesday that two doses of the company’s vaccine induced less of an immune response than against the original strain of the virus but that a third dose provided comparable protection.
“We don’t have efficacy data against omicron,” Dubovsky said. “What we do have is a technology that we think generates a broad immune response, demonstrated against a broad array of variants.”
During the J.P. Morgan Healthcare Conference earlier this year, Novavax said that it hoped eventually to market its shot to those who have not been vaccinated, those seeking a booster dose and to children. The company sees potential demand for 5 billion to 6.5 billion doses of the vaccine.