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Novavax, the non-mRNA vaccine against COVID-19 that had a clinical trial in Spokane, has cleared a major FDA hurdle for use

Dr. Jonathan Staben talks about the Novavax COVID-19 vaccine trial at the Multcare clinic at Cheney, Washington in June. Now he is overseeing a Phase 3 trial for an RSV vaccine.  (Jesse Tinsley/THE SPOKESMAN-REVI)

A highly anticipated traditional vaccine to fight COVID-19 has experts hoping it will be an attractive option for people hesitant of getting the shot from a brand that uses mRNA technology.

Novavax underwent clinical trials in Spokane and cleared another hurdle as it seeks approval for widespread use in the United States.

On Tuesday, an advisory committee at the Food and Drug Administration recommended the Novavax COVID-19 vaccine receive emergency use authorization. If granted, Novavax would be the fourth COVID-19 vaccine available in America, and the first “traditional” vaccine.

The FDA typically follows recommendations from its committee, which is composed of independent vaccine experts. Following FDA approval, the Center for Disease Control and Prevention would also need to grant approval for the vaccine to be administered nationwide.

Novavax, a biotech company based in Maryland, was one of the early competitors in the race to develop a vaccine, but manufacturing and supply chain issues have delayed the company’s efforts. The company received $1.8 billion in taxpayer funding as part of Operation Warp Speed, a federal initiative to facilitate the development and roll-out of an effective COVID-19 vaccine.

The Novavax vaccine is unlike any other currently on the market, and experts hope its traditional development will make it an attractive option for the vaccine hesitant as well as developing countries.

Both the Pfizer and Moderna vaccines are mRNA-based, which has never been used in humans prior to their development. Essentially, mRNA vaccines relay blueprints for a protein from the virus to the vaccinated patient’s cells, which then read the genetic instructions and make the protein, triggering an immune response.

The Johnson & Johnson vaccine does not use mRNA technology, but the FDA has walked back its emergency authorization for most groups because of a rare but serious potential blood-clotting side effect.

The Novavax vaccine is a direct injection of the protein itself, along with an adjuvant, a stimulant that helps heighten the body’s immune response. This recipe has been used in several effective vaccines already on the market, including the papillomavirus vaccines Cervarix and Gardasil. For those who have received a tetanus shot, it was likely protein and adjuvant, the same basic components as Novavax’s COVID-19 vaccine.

In early 2021, Novavax began clinical trials in more than 100 communities across the nation, including Spokane. The trial was conducted through MultiCare and overseen by Dr. Jonathan Staben, who said roughly 250 patients participated locally and around 30,000 participated nationwide.

Staben said they received ample interest when recruiting participants, likely due to the fact COVID-19 vaccines were not yet readily available at the time. Initially, the trial was going to be a blind study, with two-thirds of participants receiving the two-dose vaccine and the remaining third receiving a placebo.

However, as vaccines from Pfizer, Moderna and Johnson & Johnson became more readily available, they pivoted to a crossover trial. Those who initially received the placebo got the vaccine, and the vaccinated received a placebo. Staben said the pivot was an ethical decision due to the change in the standard of care, as well as a strategic decision as they did not want to lose participants due to fears of being unvaccinated.

Participants came in routinely for blood testing and follow-up appointments and received compensation for each visit – around $150 per appointment. Staben said that in a large clinical trial like this, which is at the 18-month mark of its two-year timeline, it’s normal to lose participants as the clinical trial goes on. He was impressed with their retention rate, and commended participants for their willingness to receive a vaccine at the clinical trial stage.

“I think there is some element of braveness, as they knew other vaccines were already out there,” Staben said. “It’s a testament to MultiCare’s reputation and the relationship we build with our patients. They know we’ll do our due diligence and they know they are in good hands.”

Staben recruited about 160 of his own patients to participate in the trial. He said doing the clinical trial at a community clinic like MultiCare was a big asset, as he was able to communicate directly with patients with established trust in the MultiCare staff.

Erin Robinson, director of digital content and special projects at KXLY, was one of the few hundred participants in the MultiCare clinical trial. She said she learned MultiCare was seeking participants while working at the broadcast station.

Robinson decided to participate because vaccines were not yet available to the general public, and she wanted to protect herself and her family.

“My father is immunocompromised and I wanted to see my grandpa sooner rather than later, so I decided to enroll myself and participate,” Robinson said. “Honestly, it was a really great decision. I was able to get vaccinated before those first rounds of people who received Pfizer and Moderna.”

Before the blind trial changed to a crossover trial, Robinson suspected she was in the initial group who received the vaccine. She said she felt some small side-effects, like fatigue and soreness, which is consistent with side-effects experienced after receiving any of the COVID-19 vaccines.

Robinson dropped out of the clinical trial close to a year after it began. Her wedding was in December 2021, and she would not receive a booster through the Novavax trial until January. She said she wanted to get a booster before the wedding, so she withdrew and received a Moderna booster.

“Everything was great,” Robinson said. “They ran a tight ship, it was pretty organized and the communication was really great on their end.”

Robinson said she had only a few frustrations with the experience. For a time, the participants did not have a CDC issued vaccine card, which were required at various events and businesses. The small cards they did receive, that said they were a trial participant, were not accepted at a lot of places, and it took some time before they received CDC issued vaccine cards.

“But, even last week, I went to donate blood and they were like ‘are you vaccinated?’ and I said ‘yes, I got the Novavax vaccine, it was a trial’ and I went through the whole thing and they still had to go through and verify that was okay,” Robinson said. “Having this emergency use authorization request finally go in is a pretty big relief. Hopefully it becomes a more common thing.”

The Novavax vaccine is already available in more than 40 countries, including Australia, the United Kingdom and Canada. Staben said he believes that number will continue to grow as manufacturing ramps up. The vaccine does not need to be kept at the same subzero temperatures as its competitors, meaning it may be a more accessible option for communities without the infrastructure to keep Moderna and Pfizer vaccines frozen.

Staben said the Novavax vaccine has shown to be just as effective as those from Moderna, Pfizer or Johnson & Johnson. He noted that work still needs to be done to see how any of the vaccines can be adjusted to better combat new strains as they emerge.

“This is a culmination of a huge amount of work for us, with all the challenges that come with a large-scale trial like this,” Staben said. “I’m excited to see Spokane be a part of this as a Spokane native and we would like to grow our research presence in the coming years.”