A new COVID-19 vaccine could soon be available to Americans this summer — and the familiar protein technology used to make it more palatable to those who were wary of mRNA vaccines, experts believe.
On Tuesday, the Food and Drug Administration (FDA) advisory committee will meet to review Novavax’s submission for its vaccine, dubbed NVX-CoV2373. If endorsed by the committee, the FDA will likely authorize the injection for adults 18 years and older. The move would mark the fourth vaccine to be approved for emergency use authorization in the United States.
Notably, the early approval would make it the first new vaccine to be approved in more than a year in the U.S. — and at a time when more transmissible variants of SARS-CoV-2 have become the dominant strains in the U.S., that the original vaccines were not designed to achieve. The Novavax vaccine is already approved in the European Union, Canada, South Korea, Australia, New Zealand and Indonesia.
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Given that the original strain of COVID-19 has died, having been replaced by newer, more virulent variants, the announcement of a new vaccine designed to fight the ancestral strain of SARS-CoV-2 might seem strange. However, experts tell Salon that the Novavax vaccine is particularly exciting, as it could be attractive to people who have been hesitant to receive the mRNA vaccines (which include both Moderna and Pfizer’s vaccines) due to misinformation and fear. As of June 6, 2022, an estimated 66.7% of the US population is fully vaccinated against COVID-19, according to the Centers for Disease Control and Prevention (CDC); which includes 76% of adults over the age of 18.
“Unfortunately, some of the other vaccines have been vilified by the antivaccine movement because they are not protein-based,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center, to the Salon. “This is a protein vaccine, it is very similar to other vaccines that people routinely receive, so perhaps those individuals who have unfortunately been swayed by misinformation about the other vaccines might find this one more appropriate.” Adalja added that while this vaccine is “more traditional”, it is also innovative in its own way.
“Unfortunately, some of the other vaccines have been vilified by the antivaccine movement because they are not protein-based,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center, to the Salon.
As Salon previously reported, anti-vaccine conspiracy theorists have spread misinformation that mRNA vaccines can alter a person’s DNA. This is not true, as the vaccine essentially sends instructions to our immune system on how to recognize the coronavirus’ Spike protein and fight it. The benefit of mRNA vaccines is that they are easier to produce in a shorter period of time and easier to modify in the future – hence their success in the coronavirus vaccine race. As for Johnson & Johnson’s vaccine, theirs uses an altered genetic snippet of the SARS-CoV-2 virus inserted into a cold virus so that it produces the coronavirus’s Spike protein, although it cannot make a person sick because it cannot become sick. replicate in the body.
As Adalja noted, the Novavax vaccine is different from Pfizer’s and Moderna’s mRNA vaccines and Johnson & Johnson’s adenovirus vaccine because it uses a protein technology. That means the vaccine already contains a replica of the Spike protein that was created using moth cells and an adjuvant that boosts the immune system. Since the Spike protein is already in the vaccine, it doesn’t have to be manufactured in a person’s body by the immune system itself. According to the results of Novavax’s 30,000-person trial, the vaccine is 90% effective against symptomatic COVID-19 infections and 100% protective against moderate and severe illness. Notably, these numbers were calculated before the era of the omicron variant of the pandemic.
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Like Adalja, Monica Gandhi, an infectious disease expert and professor of medicine at the University of California-San Francisco, said she is hopeful that if the vaccine is approved, it will appeal to people who have been hesitant to vaccinate — and “any adult who has refused the vaccine”. other vaccines for some reason,” Gandhi said. She also opined that it would be “a very good booster” for the segment of the population that is already vaccinated.
In fact, while those who are fully vaccinated will not be the ones lining up to be vaccinated again — and while approval is only for an initial vaccination series — some experts hope the Novavax vaccine could be used as a future booster.
“The reason I’m intrigued by the Novavax vaccine booster is because the Novavax vaccine is the real protein, and it’s a much longer piece of the protein, and it also includes what’s called the receptor-binding domain,” Gandhi said. . “And that part of the receptor-binding domain actually tends to be quite conserved across the variants, so that bit of the Spike protein doesn’t change that much.”
As an example, Gandhi noted that in the omicron variant, the receptor-binding domain remains the same – despite its 32 mutations compared to the primordial virus.
But at this point, would the country be better off with new vaccines that actually target new variants? The omicron BA.2 subvariant is much more transmissible than earlier variants such as delta and alpha, and the vaccine’s efficacy appears to decrease with each subsequent variant.
Adalja said the answer to that question depends on what the vaccines are for.
“If our goal is to prevent serious illness, hospitalization and death, vaccines targeting the ancestral strain are doing very well,” Adalja said. “But if you’re trying to prevent infections, they’re clearly not able to do that as well as they were in the omicron era.”
If the goal is to completely block transmission, Adalja believes that future vaccines targeting specific strains could be more effective.
“I think an update of the vaccine to be better targeted at the variants that are circulating should be a goal,” Adalja said.
An FDA review of Novavax documents raised concerns about the risk of myocarditis and pericarditis associated with vaccines; these conditions have also been associated with mRNA vaccines. However, the FDA seemed optimistic about how it would fare with current variants.
“Relevant data to assess the effectiveness of [the Novavax vaccine] against the Omicron variant and strains, including observational data from use in other countries where the vaccine has been deployed, are currently unavailable,” the FDA wrote. “However, based on the estimated efficacy in the clinical trial of this vaccine, it is more likely that the vaccine provides some significant level of protection against COVID-19 due to Omicron, in particular against more serious diseases.”
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