FDA advisory panel to consider approving fourth COVID-19 vaccine, this one from Maryland's Novavax

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

Development of the vaccine, from Novavax, a Gaithersburg, Maryland-based company, 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)," said Vivian 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 to three-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-produced in insect cells instead of the body, and delivered with an adjuvant that boosts its effectiveness. Such protein-based vaccines have been used to prevent hepatitis B, pertussis, pneumonia and meningococcal 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 declining the other three.

"I wouldn't put it at zero," said Prashant 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 company will 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 in our country but you should use it," he said.

Losing support  

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's vaccine will prove as useful as the others.

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

Production issues    

Novavax had been a small company, with fewer than 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 proved safe and effective in lab and animal studies, though those took longer to complete than the mRNA research.

Novavax's clinical trials started in late 2020, about the same time the two 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 of Europe, 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's plan "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, Riefberg said.

Bringing a vaccine to market involves more than simply developing the shot. "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. 

Vaccine details      

Novavax submitted its vaccine application for adults to the Food 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 questions about the cardiovascular impacts of the shot, which the Vaccines and Related Biological Products Advisory Committee will 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 Tuesday whether to authorize emergency use 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 a Centers for Disease Control and Prevention advisory panel and then its director.

Contact Karen Weintraub at kweintraub@usatoday.com.

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