The U.S. government has tapped a sixth vaccine-maker to receive big federal bucks as the Trump administration races to approve a COVID-19 vaccine by the end of the year. But this latest vaccine candidate, from Maryland-based pharma Novavax, might be the riskiest yet.
Novavax has been in the pharmaceuticals business since 1987 but has yet to get a single vaccine past the U.S. Food and Drug Administration. And Novavax’s vaccine candidate itself is risky. It’s what’s known as a “recombinant nanoparticle vaccine.” The key component is a lab-grown version of the spiky protein that’s a signature of the novel coronavirus, and which helps the virus bind to a person’s cells.
Novavax plans to grow the proteins in insect cells and then add them to the baculovirus, which would function as a carrier of the man-made proteins.
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With its “fake” protein spike, Novavax’s vaccine could, in theory, block actual coronavirus from infecting cells. But if the developers at Novavax fail to closely copy the real virus’s spike, the vaccine might not work very well. Novavax did not respond to a request for comment.
The U.S. Department of Health and Human Services, which oversees Operation Warp Speed, the feds’ $13-billion coronavirus-vaccine push, announced the $1.6-billion Novavax spend on Tuesday. HHS did not respond to a request for comment.
“Depending on success in clinical trials, today’s $1.6-billion investment supports our latest vaccine candidate, being developed by Novavax, all the way through clinical trials and manufacturing 100 million doses for the American people,” HHS secretary Alex Azar stated.
Operation Warp Speed previously selected five vaccine-makers to receive major federal funds: Moderna; a consortium of AstraZeneca and Oxford University; Johnson & Johnson; Merck; and Pfizer.
AstraZeneca and Oxford have already begun large-scale, phase-three trials in the United Kingdom, Brazil, and South Africa. Moderna began phase-three trials this week in the United States. Johnson & Johnson plans to begin its own large-scale trials later this month.
Officially, the goal is to produce 300 million doses of a vaccine by January 2021. Anthony Fauci, the head of the National Institute for Allergy and Infectious Diseases, stressed that the January goal is “aspirational, but it’s certainly do-able.”
Several of the leading pharmas have already begun manufacturing doses in the hope of having sizable stockpiles if and when the FDA approves their vaccines. As part of a separate, $70-million deal with the feds back in June, Novavax has already begun producing doses.
Stanley Erck, Novavax’s president and CEO, told medical news site STAT that the company could ship all 100 million doses by February. Erck said the Novavax vaccine is likely to require two doses. The company is currently in phase-one and -two trials with its vaccine and expects to begin phase-three trials with 30,000 patients in the fall.
The six vaccine-candidates receiving major federal funds represent a wide array of technologies.
Moderna’s vaccine candidate, like Pfizer’s, is an mRNA vaccine that includes a synthetic version of the messenger-RNA that a virus uses to build its infectious proteins. Meanwhile, Johnson & Johnson and the AstraZeneca-Oxford consortium are working with so-called “live-virus” vaccines that include inactive or weak versions of the novel-coronavirus.
Even if all five vaccine candidates complete development and the FDA approves each for public use, there still could be big differences in their effectiveness. “It is not clear where the active immunities resulting from different vaccines will be exactly the same,” Dmitry Korkin, a bioinformatics researcher at the Worcester Polytechnic Institute in Massachusetts, told The Daily Beast.
Fei Wen, a chemical engineer at the University of Michigan, stressed that Novavax is a “reputable” company. “I don't doubt its technical capabilities,” Wen told The Daily Beast. “With that said, the technology itself— i.e, virus-like nanoparticles produced in insect cells using baculovirus as gene carrier— might have some limitations for pandemic vaccine development related to scalability, cost and effectiveness.”
“Novavax's vaccine candidate may be less effective compared to the live-virus-based vaccines. This is because again the technology itself may not be able to produce nanoparticles that have as high a density of the spike proteins, which is critical for protective immune response.”
Paul Offit, chief of the division of infectious diseases at the Children's Hospital of Philadelphia, told The Daily Beast that Novavax’s artificial protein-spike is based on proven technology, however. There are flu vaccines that take a similar approach.
Besides, Offit added, risky vaccines such as Novavax’s are a useful part of the Operation Warp Speed mix. “The more horses you put in the race, the more likely you are to win.”
Wen proposed a different approach, albeit one that would only help with the next pandemic. Rather than scrambling to fund a bunch of risky vaccine-candidates all at the same time after a virus has already infected millions of people, authorities could spend more money on vaccine-development between pandemics.
“Rushing vaccine-development in a reactive response to a pandemic in my view is going to lead to potentially wasteful allocation of resources,” Wen said. “Learning from this, a proactive sustained investment in pandemic preparedness should be considered moving forward.”
