Novavax’s protein-based coronavirus vaccine would be the fourth to gain

For most people, some already on their third or fourth messenger RNA coronavirus shot from Moderna or Pfizer-BioNTech, it’s a puzzle: A new vaccine? Now? Why bother?

But for a small contingent of holdouts who have closely tracked the progress of the Novavax vaccine, this is a long-awaited moment of truth.

“Some people can’t take the mRNA vaccines, and it’s important to have a choice,” said Victoria Dawson, 74, of New York, who is allergic to an ingredient in the mRNA shots. She received a Johnson & Johnson shot and booster but hopes her next shot will be from Novavax.

“I’m being very cautious. I’m staying around my apartment complex and not eating in restaurants,” Dawson said. “I get up in the morning and just stress the minute I get up.”

Even though Novavax lost the race to be first, company executives argue that their shot will help fill in the margins of the pandemic vaccination campaign and play an important role in helping people live alongside the virus into the future.

They argue that their vaccine, which can stay stable at refrigerator temperatures long-term and may be better tolerated than alternatives, will have key advantages once the exigencies of the pandemic recede. But hopes were dashed Friday that the vaccine would offer an alternative for people worried about rare heart inflammation associated with mRNA vaccines. An FDA review found that there were five cases of inflammation, mostly in men, within two weeks of being vaccinated in the company’s trials, “raising concern for a causal relationship.”

The Novavax vaccine is poised to hit the U.S. market as more than three-quarters of people 18 and older are already fully vaccinated. Among the unvaccinated, some may be waiting for another option, but others may not be interested at all. Novavax plans to seek expanded authorization for use of the shot in adolescents and as a booster.

The vaccine’s rollout is likely to be slower than that of earlier coronavirus vaccines, which were available days after FDA advisers met.

An agency review released Friday said that testing and submission of manufacturing information about the vaccine was “still in process” and would be essential “to ensure the vaccine’s quality and consistency for authorization.” A meeting of Centers for Disease Control and Prevention vaccine advisers, a critical step before a vaccine becomes available, has not been scheduled yet. The company plans to have shots ready to supply “within a very short period of time” — a few weeks after the FDA authorizes the shot, said John Trizzino, chief commercial officer at Novavax.

Despite the late arrival of their vaccine, Novavax executives remain confident it will fill a need.

“If you would have asked anybody in the space 12 months ago what would be happening in the pandemic now, they would have said, ‘Oh, by now we’d be long past the pandemic,’ ” Trizzino said.

In a brightly lit laboratory in Gaithersburg, Md., a cloudy, yellowish broth swirls inside Erlenmeyer flasks. The glass containers, shaking back and forth inside two incubators, are teeming with cells from a pest known as the fall armyworm moth.

Those moth cells are tiny vaccine factories, churning out coronavirus spike proteins found in the newest omicron subvariants, BA.4 and BA.5. Even as Novavax scientists wait for their first-generation vaccine to be authorized — based on earlier versions of the virus — they are working on new formulations to be ready for wherever the pandemic swerves next.

The winding path to this moment — a vaccine on the cusp of authorization a year after it was shown to be 90 percent effective — underscores the speedy development of the first vaccines. The time lag for the Novavax vaccine reflects a combination of factors: the more time-consuming technology used in the company’s shot; the growing pains of a small company that had to expand quickly; and manufacturing delays.

What makes Novavax’s vaccine attractive to some people — that it’s an older, more familiar technology — is also what made it trail other shots. Protein-based shots are tried and true — they’re used against influenza, hepatitis B and shingles. But the timeline to develop them is longer.

The newer mRNA vaccines instruct cells inside the body of vaccine recipients to build the coronavirus spike protein. The J&J shot uses a harmless virus to spur cells to churn…