Independent advisers to the Food and Drug Administration have voted 21 to 0 to recommend the authorization of Novavax’s COVID-19 vaccine for pandemic emergency use.
If green-lit following the Tuesday vote, Nuvaxovid would be the fourth COVID-19 vaccine approved in the United States and the first made with an older protein-based technology that’s also used in shingles vaccines and other shots.
Familiarity may ease concerns
Some federal health officials and the drugmaker are hoping that this familiarity may help ease the concerns some Americans have about new mRNA vaccine technology and thereby encourage more vaccinations.
“Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccines,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said during the advisory committee’s Tuesday meeting, according to NBC News.
Older Americans have the highest rates of full vaccination plus a booster shot against COVID-19. In nursing homes, 81% of residents were fully vaccinated and had received a booster dose by the end of May, according to federal data. But this was true of only 53% of staff members. And there are about 27 million American adults who remain unvaccinated, according to Reuters.
Nuvaxovid has compared well with other U.S.-approved COVID-19 vaccines. The drug was 90% protective against infection and 100% against moderate to severe illness, according to the company’s data. It can be stored in a refrigerator, making it easier to distribute than mRNA vaccines. And it has had positive results when tested in combination with a flu shot.
Experts have also raised some concerns. The drug’s trial timeline did not include the omicron era, prompting some to question its current efficacy. In addition, Nuvaxovid has been linked to rare heart inflammation side effects, a problem which also has dogged the Pfizer and Moderna shots.
But members of the FDA’s Vaccines and Related Biological Products Advisory Committee agreed that potential benefits of the drug outweighed concerns.
Novavax was originally awarded funds in 2020 to expedite development of a COVID-19 vaccine under the federal government’s Operation Warp Speed program. Production issues contributed to a slow rollout and the company finally submitted a bid for FDA approval of its new vaccine in January.
More than 40 other countries, including many in the European Union, have already approved Nuvaxovid, according to the Mercury News.