For most people, some already on their third or fourth messenger RNA coronavirus shot from Moderna or Pfizer-BioNTech, it looks like a puzzle: A new vaccine? Why bother? But for a small contingent of holdouts who have closely tracked the progress of the Novavax vaccine, this is a moment of truth.
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 their vaccine, which can stay stable at refrigerator temperatures longer 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 Novavax 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 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 testing and submission of manufacturing information about the vaccine were “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.
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 lag for the Novavax vaccine reflects a combination of factors, including the more time-consuming technology used in its coronavirus shot, the growing pains of a small company that had to expand quickly and manufacturing delays.
What makes the Novavax vaccine attractive to some people is that it is an older and more familiar technology. That is also what made it trail other shots. Protein-based shots are tried and true. They are used against influenza, hepatitis B and shingles. However, 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 Johnson & Johnson vaccine uses a harmless virus to spur cells to churn out the spike protein. Novavax, by contrast, manufactures and purifies the coronavirus spike proteins in a laboratory.
Novavax scientists start with a baculovirus, which in nature infects insects. It is engineered to carry genetic instructions for building the coronavirus spike protein. The baculovirus, with its genetic instructions, is then introduced into cells taken from the fall armyworm moth.
The Novavax coronavirus shot was one of six candidates backed by Operation Warp Speed, the federal program established to accelerate vaccine development. The government invested $1.6 billion in the Maryland company to support development of the shots. Even with the influx of cash, the challenges to scale up were enormous.
The Novavax workforce exploded during the past two years to 1,600 employees, and a new headquarters is under construction. The growth is visible in every department. In a glass corridor, scientists receive frozen patient samples from vaccine trials around the world.
Last year, a staff of nearly 60 received and analyzed results from about 100,000 samples. So far this year, they have analyzed 87,000 and are looking to expand the lab to double their capacity by next year.
A Guest Editorial