There’s One Thing Standing Between Us and the Nuvaxovid COVID Vaccination of Our Dreams

The new COVID-19 vaccine from Novavax is safe and effective. Better yet, it’s easy to ship and store, making it ideal for poorer countries that are still under-vaxxed.

The company’s shot, called Nuvaxovid, could reshape the vaccine landscape as the pandemic grinds into its 32nd month. More protection for more people against ever-more-contagious new variants of the SARS-CoV-2 virus.

Assuming Novavax can produce enough doses on time, that is. Manufacturing problems could doom the new jab’s wider rollout.

The U.S. Food and Drug Administration gave Nuvaxovid emergency-use authorization on July 13, approving the shot for Americans ages 18 and older. “The vaccine meets the FDA’s high standards for safety and effectiveness for emergency-use authorization,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Possible side effects, though rare, include an allergic reaction, heart inflammation, fatigue and nausea, among other risks.

Forty countries, mostly in Europe, had already approved Nuvaxovid before the FDA decision. But uptake was low. The abundance of vaccine options in Europe—and a surplus of jabs—could be a factor. But Novavax’s struggle to manufacture doses on time is probably a much bigger factor. Novavax didn’t respond to a request for comment.

It’s not totally clear that Maryland-based Novavax has solved its production problems. We could be about to find out. The number of countries where Nuvaxovid has the green light could increase in coming weeks, as health regulators take a cue from the FDA and bet on Nuvaxovid’s highly shelf-stable design to ease distribution and boost local uptake.

There’s a lot that could go wrong.

To be clear, Nuvaxovid itself isn’t the problem. Novavax’s two-dose vaccine is both like and unlike the other leading vaccines, including the messenger-RNA jabs from Massachusetts-based Moderna and Pfizer in New Jersey.

The mRNA vaccines include genetic instructions that tell our immune systems to produce antibodies and T-cells for attacking the novel-coronavirus’s spike protein, the part of the virus that allows it to grab onto and infect our cells.

Nuvaxovid includes an engineered fragment of the spike protein itself—albeit one without the genetic material that causes actual disease.

It’s not a totally new approach to vaccine design. There are similar jabs for shingles, tetanus and other diseases. But with its disease-free protein fragment, the Novavax vaccine stands out from the other COVID jabs.

It’s just as effective as the mRNA vaccines, preventing illness in 90 percent of cases, according to the FDA. And because it’s highly stable and doesn’t require intensive cold storage like mRNA does, it’s a lot easier to ship and store.

The mRNA vaccines go bad after less than a day outside of a freezer. Nuvaxovid lasts six months under the same conditions. “The Novavax vaccine is much less demanding,” Fei Wen, a chemical engineer at the University of Michigan, told The Daily Beast.

That’s not terribly important in a rich country with a sophisticated supply chain featuring plenty of refrigerator trucks and freezers. But it’s hugely important for some poor countries that might not even have a fully paved road network, to say nothing of clinics with industrial freezers.

“Novavax does have some logistical advantages with cold-chain requirements that make it really useful in rural settings or low and middle-income countries that struggle with distribution chains,” James Lawler, an infectious disease expert and a colleague of Wiley at the University of Nebraska Medical Center, told The Daily Beast. “For the global vaccination campaign, that is a big deal.”

It’s those poorer countries that are most in need of vaccine right now. Globally, 62 percent of people are fully vaccinated against COVID with two doses of mRNA or one dose of a single-shot jab such as the one from Johnson & Johnson. But in Africa, just 18 percent of people are fully vaccinated.

Novavax could significantly boost vaccine uptake in Africa, assuming financing comes through and production keeps up.

The financing is complicated. Countries can cut their own deals with Novavax, of course. But poorer countries can also get jabs from COVAX, an international vaccine-distribution consortium with $11 billion in funding from richer countries. COVAX has already ordered more than 1 billion doses of Nuvaxovid.

But production is even more complicated than financing. And that’s where Nuvaxovid could fizzle.

Novavax is a comparatively small company, with revenue totalling just $1 billion in 2021. For comparison, Moderna logged $19 billion in sales the same year. While it’s not uncommon for even a wealthier pharmaceutical firm to outsource aspects of drug-production, Novavax relies almost totally on outside firms to manufacture doses.

That manufacturing dependency is one reason why it took so long for Novavax to get the nod from the FDA, 20 months after the agency approved the first COVID vaccine, Moderna’s, for distribution in the U.S. Novavax first applied to the FDA for emergency use authorization in January. Five months later, the FDA was still scrutinizing the company’s production plans.

The agency had reason to be skeptical. Novavax quickly fell behind on its initial orders from earlier this year, including the big COVAX deal and smaller sales to the Philippines and Indonesia.

“I conjecture some of the delays in this particular case have occurred because it is a smaller company, without existing products, partnering with contract manufacturers and without as many existing systems,” Julie Swann, a systems engineering professor and vaccine-distribution expert at North Carolina State University, told The Daily Beast.

The open question, for Novavax and its customers, is whether FDA authorization, and big orders from the U.S. government, drives improvements in the company’s processes—or weighs the firm down.

Novavax’s biggest subcontractors include Baxter International in Illinois and Serum Institute of India. Experts are cautiously optimistic that Baxter and Serum can scale up Nuvaxovid production. More vats for growing proteins. More lines for filling vials. More workers loading trucks, trains and planes. “The partners that Novavax is working with to stand up international production are world-class in scaling biological production processes,” Lawler said.

If the factories can start churning out doses on time, the result could be more vaccinations in the countries that need them the most.

If the factories fall further behind, demand could collapse and Nuvaxovid could fail. That would be disastrous for Novavax. And even more disastrous for hundreds of millions of people in poor countries who still need access to a good COVID vaccine.

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