Novavax’s new COVID-19 vaccine is safe and effective. Best of all, it’s easy to ship and store, making it ideal for poorer countries that are still under-vaxxed.
The company’s vaccine, called Nuvaxovid, could reshape the vaccine landscape as the pandemic enters its 32nd month. More protection for more people against new and increasingly contagious variants of the SARS-CoV-2 virus.
Assuming Novavax can produce enough doses on time, that is. Manufacturing issues could doom the wider rollout of the new jab.
The U.S. Food and Drug Administration issued emergency use authorization for Nuvaxovid on July 13, approving the vaccine for Americans ages 18 and older. “The vaccine meets the FDA’s high standards for safety and efficacy 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’s decision. But adoption was low. Europe’s abundance of vaccine options – and a glut of shots – could be a factor. But Novavax’s struggle to make doses on time is probably a lot bigger factor. Novavax did not respond to a request for comment.
It’s not entirely clear that Maryland-based Novavax has resolved its production issues. We could be about to find out. The number of countries where Nuvaxovid has the green light could grow in the coming weeks as health regulators take cues from the FDA and bet on Nuvaxovid’s highly stable design to ease distribution and drive local adoption.
There are many things that could go wrong.
To be clear, Nuvaxovid itself is not the problem. The two-dose Novavax vaccine is both As and contrary to other major vaccines, including messenger RNA injections from Moderna and Pfizer, of Massachusetts, New Jersey.
mRNA vaccines include genetic instructions that tell our immune system to produce antibodies and T cells to attack the new coronavirus’ spike protein, the part of the virus that allows it to grab onto and infect our cells.
Nuvaxovid includes a modified fragment of the spike protein itself, but without the genetic material that causes the actual disease.
This is not a totally new approach to vaccine design. There are similar shots for shingles, tetanus and other diseases. But with its disease-free protein fragment, the Novavax vaccine stands out from other COVID jabs.
It is just as effective as mRNA vaccines, preventing disease in 90% of cases, according to the FDA. And because it’s very stable and doesn’t require intensive cold storage like mRNA does, it’s much easier to ship and store.
mRNA vaccines deteriorate 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.
This is not very important in a wealthy country with a sophisticated supply chain including many refrigerated trucks and freezers. But it’s extremely 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 settings or low- and middle-income countries that struggle with supply chains,” James Lawler, infectious disease expert and colleague of Wiley at the University of Nebraska Medical Center, told the Daily Beast. “For the global vaccination campaign, this is a big deal.”
These are the poorest countries that need vaccines the most right now. Globally, 62% 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% of people are fully vaccinated.
Novavax could dramatically increase vaccine uptake in Africa, assuming funding comes through and production sustains.
Funding is complicated. Countries can of course enter into their own agreements with Novavax. But poorer countries can also get hits from COVAX, an international vaccine delivery consortium with $11 billion in funding from wealthier countries. COVAX has already ordered more than one billion doses of Nuvaxovid.
But production is even more complicated than financing. And that’s where Nuvaxovid could sparkle.
Novavax is a relatively small company, with revenues totaling just $1 billion in 2021. By comparison, Moderna saw $19 billion in sales in the same year. While it’s not uncommon for even a wealthier pharmaceutical company to outsource some aspect of drug production, Novavax relies almost completely on outside companies to manufacture doses.
This dependence on manufacturing is one of the reasons it took so long for Novavax to gain FDA approval, 20 months after the agency approved the first COVID vaccine, Moderna’s, for distribution in the United States. United. Novavax first applied to the FDA for emergency use authorization 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 initial orders from earlier this year, including the big COVAX deal and small sales in the Philippines and Indonesia.
“I suspect some of the delays in this particular case have happened because it’s a small company, with no existing products, partnering with contract manufacturers, and not as many existing systems,” Julie Swann, professor in systems engineering and an expert in vaccine distribution at North Carolina State University, told the Daily Beast.
The open question, for Novavax and its customers, is whether FDA clearance and large US government orders are driving improvements in business processes or burdening the business.
Novavax’s main contractors are Baxter International in Illinois and Serum Institute of India. Experts are cautiously optimistic that Baxter and Serum can scale up production of Nuvaxovid. More vessels for protein culture. More lines for filling bottles. More workers loading trucks, trains and planes. “The partners Novavax works with to support international production are world-class in scaling organic production processes,” Lawler said.
If factories can start producing doses in time, the result could be more vaccinations in the countries that need them most.
If factories fall further behind, demand could collapse and Nuvaxovid could fail. It would be disastrous for Novavax. And even After disastrous for hundreds of millions of people in poor countries who still need access to a good COVID vaccine.