Novavax COVID-19 vaccine to be considered by FDA panel as 4th in US – USA TODAY

Novavax aims to bring new COVID shot option to US

Americans may soon get a new COVID-19 vaccine option a more traditional kind of shot known as a protein vaccine. It's late in the pandemic for a new choice, but Novavax is hoping to find a niche with those who are unvaccinated or need boosters. (June 2)

AP

A federal vaccine advisory committee meets Tuesday to decide whether Americans could soon get a fourth COVID-19 vaccine option.

Development of the vaccine, from Novavax, a Gaithersburg, Maryland-basedcompany, was started at the same time as others in 2020, but the company struggled to produce its shot in large quantities.

A more traditional vaccine than some of the others, it might encourage some vaccine holdouts to get the shots, experts said.

"There's a lot of reasons that are not scientifically based for not having taken the vaccine (yet)," saidVivian Riefberg,a professor at the Darden School of Business at the University of Virginia. "This may convince some people because it's traditional technology."

The Moderna and Pfizer-BioNTech shots, which have been given tothree-quarters of the American population,are based on mRNA technology, which teaches the body to make the spike protein found on the surface of the coronavirus that causes COVID-19. Once the immune system recognizes the spike protein, it will attack the viral cells.

The Novavax vaccine provides the spike protein directly, mass-producedin insect cells instead of the body,and delivered with an adjuvant that boosts its effectiveness. Such protein-based vaccines have been used to preventhepatitis B, pertussis, pneumonia andmeningococcal disease, among other diseases.

(The J&J vaccine, which regulators have said should be a secondary choice after the mRNA shots, uses a harmless virus to deliver the same spike protein.)

It's unclear how many people will want to get vaccinated with the two-dose Novavax shots, after decliningthe other three.

"I wouldn't put it at zero," saidPrashant Yadav, a lecturer at Harvard T.H. Chan School of Public Health who studies healthcare supply chains.

But in the United States, Novavax is more likely to eventually play a role as a booster.

"There is this ongoing need, ongoing market, for a safe effective COVID vaccine into the foreseeable future," John Trizzino, the company's executive vice president, chief commercial officer and chief business officer, said in a recent call with media.

Novavax is currently only asking for permission to provide its shots as a primary, two-dose vaccine to people who are not yet protected. The companywill have to present more data to regulators before their vaccine can be offered as a booster.

The Novavax vaccine is already available in more than 40 countries and is expected to be particularly useful in low- and middle-income countries, which may not have the freezer capacity required for long-term storage of the mRNA vaccines.

Still, it's important to authorize its use here, Yadav said.

"We can't go and tell the rest of the world that we are not going to use it inour country but you should use it," he said.

Travel writer Troy Petenbrink had been such an enthusiastic supporter of Novavax's shot that he volunteered in 2020 to participate in its vaccine trial.

But he soured on the company after he was left in limbo by the vaccine's delays not considered fully vaccinated, but unable to get answers from Novavax about what he should do.

"We kept asking and nothing," he said. "I couldn't go to the theater. I couldn't travel. I had to get a 'real' shot."

The Washington, D.C., resident ended up dropping out of the trial and getting the two-dose Moderna vaccine on top of his two doses of Novavax.

Still, Petenbrink hopes Novavax'svaccine will proveas useful as the others.

"Maybe in the future they'll have their act together and they'll bring better products to market," he said.

Novavax had been a small company, with fewerthan 100 employees, no products on the market and a disappointing clinical trial when it was awarded a total of $1.8 billion in U.S. tax dollars to develop, test and produce a COVID-19 vaccine.

It quickly showed safe and effectivein lab and animal studies, though those took longer to complete than the mRNA research.

Novavax's clinical trials started in late 2020, aboutthe same time thetwo mRNA vaccines were authorized, and at a time when COVID-19 rates had started to fall so it took longer to get the required number of infections to prove the shots'effectiveness.

Then came production issues.

Yadav said he thinks the company tried to go after more than it could handle, producing vaccine at large scale in multiple countries "too quickly, too early."

Instead of focusing on perfecting the manufacturing process at their production plant in North Carolina,"they were going after a geographic footprint ofEurope, Asia, Latin America and North America, to come up simultaneously and start producing."

If the plan had worked, he said, Novavax's shots would have been the best in the world. But the company'splan "had hiccups," Yadav said, including trouble attracting skilled people to staff all those facilities. The rollout was delayed in every country.

The vaccine could have been available sooner if the company had more experience with vaccine development or paired with a more experienced company,like BioNTech did, Riefbergsaid.

Bringing a vaccine to market involves more than simply developing theshot. "We all tend to focus on the innovation in the creation of the new (vaccine) and not the innovation in the scaling, because it's not as sexy but it's as important, sometimes more important," she said.

Novavax submitted its vaccine application to theFood and Drug Administration on Feb. 1 and the agency has been considering it since.

To win emergency authorization, the company must show its vaccine is safe, effective and can be produced consistently at scale.

The Novavax vaccine appears somewhat less effective in people over 65, providing 79% protection against symptomatic disease, compared to 91% protection among younger adults. The study didn't have many older participants who fell ill, though, so those figures may not be accurate, the FDA review noted.

In its analysis of Novavax's data,the FDA raised questionsabout the cardiovascular impacts of the shot, which the Vaccines and Related Biological Products Advisory Committeewill discuss in a daylong meeting Tuesday.

Six participants who received the active vaccine and one who got a placebo developed myocarditis or pericarditis, a swelling of the heart muscle that has also been seen with the mRNA vaccines.

Five of the events were reported within two weeks of the shots and are believed to be connected. Four occurred in young men, which is the group that has been the most vulnerable to myocarditis after other COVID-19 vaccines.

Real-world evidence suggests that the risk of myocarditis following the Novavax vaccine could be even higher than with mRNA vaccines, according to the FDA review.

In a statement released over the weekend, Novavax said myocarditis is relatively common and the cases seen may be coincidental, not caused by the vaccine.

"We believe there is insufficient evidence to establish a causal relationship," according to the statement. "We will continue to monitor all adverse events, including myocarditis and pericarditis."

The advisory committee will vote at the end of its eight-hour meeting Tuesdaywhether to authorize emergencyuse of the Novavax vaccine. If it does, the head of the FDA will need to sign off on the vaccine, before it is reviewed by aCenters for Disease Control and Prevention advisory panel and then itsdirector.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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