One thing stands between us and the Nuvaxovid-COVID vaccine of our dreams

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

The company’s shot, dubbed Nuvaxovid, could reshape the vaccine landscape as the pandemic enters its 32nd month. More protection for more people from increasingly contagious new variants of the SARS-CoV-2 virus.

Assuming Novavax can produce enough doses in time. Manufacturing issues could derail the wider adoption of the new Jab.

The U.S. Food and Drug Administration granted Nuvaxovid emergency use authorization on July 13, clearing the injection for Americans ages 18 and older. “The vaccine meets FDA’s high safety and efficacy standards for emergency use authorization,” Peter Marks, director of the FDA’s Center for Biological Agents Evaluation and Research, said in a statement.

Possible side effects, although rare, include an allergic reaction, heart inflammation, fatigue, and nausea, among others.

Forty countries, mainly in Europe, had already approved Nuvaxovid before the FDA decision. But the uptake was low. The plethora of vaccine options in Europe – and a glut of vaccinations – could be a factor. But Novavax’s struggle to make doses on time is likely to be huge greater Factor. Novavax did not respond to a request for comment.

It’s not entirely clear that the Maryland-based company Novavax has solved its production problems. We could find out right now. The number of countries where Nuvaxovid has the green light could increase in the coming weeks as health authorities align with the FDA and rely on Nuvaxovid’s highly shelf-stable design to facilitate distribution and encourage local uptake.

A lot can go wrong there.

To be clear, Nuvaxovid itself is not the problem. Novavax’s two-dose vaccine is both how and not how the other leading vaccines, including messenger RNA syringes from Massachusetts-based Moderna and New Jersey-based Pfizer.

The mRNA vaccines contain genetic instructions that tell our immune system to produce antibodies and T-cells to attack the novel coronavirus’s spike protein, the part of the virus that allows it to latch on to our cells and close them infect.

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

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

It is as effective as the mRNA vaccines and prevents disease in 90 percent of cases, according to the FDA. And because it’s very stable and doesn’t require intensive cold storage like mRNA, it’s much easier to ship and store.

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

This is not particularly important in a rich country with a sophisticated supply chain with many refrigerated trucks and chest freezers. But it is enormously important for some poor countries that may not even have a fully paved road network, let alone clinics with industrial freezers.

“Novavax has some logistical advantages with cold chain requirements that make it really useful in rural areas or in low- and middle-income countries that are struggling with distribution chains,” says James Lawler, an infectious disease expert and Wiley’s colleague at the University of Nebraska Medical Center, The Daily Beast said. “It’s a big deal for the global immunization campaign.”

It’s the poorer countries that are most in need of a 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 vaccine like Johnson & Johnson’s. But in Africa, only 18 percent of people are fully vaccinated.

Novavax could significantly increase vaccine uptake in Africa, assuming funding comes in and production continues.

Financing is complicated. Countries can of course do their own business with Novavax. But poorer countries can also get vaccines from COVAX, an international vaccine distribution consortium funded by richer countries with $11 billion. COVAX has already ordered more than 1 billion doses of Nuvaxovid.

But the production is even more complicated than the financing. And this is where Nuvaxovid could fizzle out.

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

This manufacturing dependency is one reason it took Novavax so long to get FDA approval, 20 months after the agency approved the first COVID vaccine, Modernas, for distribution in the U.S. Novavax first filed with the FDA for emergency use in January. Five months later, the FDA was still reviewing 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 large COVAX deal and smaller sales to the Philippines and Indonesia.

“I suspect some of the delays in this particular case are because it’s a smaller company, with no existing products, partnerships with contract manufacturers, and without as many existing systems,” Julie Swann, professor of systems engineering and vaccine distribution expert at North Carolina State University, The Daily Beast said.

The unanswered question for Novavax and its customers is whether FDA approval and major US government contracts will improve the company’s operations — or weigh it down.

Among Novavax’s largest subcontractors are Baxter International in Illinois and the Serum Institute of India. Experts are cautiously optimistic that Baxter and Serum can increase production of Nuvaxovid. More vats for growing proteins. More lines for filling bottles. More workers load trucks, trains and planes. “The partners that Novavax is working with to advance international production are world-class at scaling biological production processes,” said Lawler.

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

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


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