Photograph Illustration by Elizabeth Brockway/The Each day Beast/Getty
The brand new COVID-19 vaccine from Novavax is secure and efficient. Higher but, it’s straightforward to ship and retailer, making it excellent for poorer international locations which might be nonetheless under-vaxxed.
The corporate’s shot, known as Nuvaxovid, might reshape the vaccine panorama because the pandemic grinds into its thirty second month. Extra safety for extra folks in opposition to ever-more-contagious new variants of the SARS-CoV-2 virus.
Assuming Novavax can produce sufficient doses on time, that's. Manufacturing issues might doom the brand new jab’s wider rollout.
The U.S. Meals and Drug Administration gave Nuvaxovid emergency-use authorization on July 13, approving the shot for Individuals ages 18 and older. “The vaccine meets the FDA’s excessive requirements for security and effectiveness for emergency-use authorization,” Peter Marks, director of the FDA’s Heart for Biologics Analysis and Analysis, stated in an announcement.
Attainable uncomfortable side effects, although uncommon, embody an allergic response, coronary heart irritation, fatigue and nausea, amongst different dangers.
Forty international locations, principally in Europe, had already accepted Nuvaxovid earlier than the FDA resolution. However uptake was low. The abundance of vaccine choices in Europe—and a surplus of jabs—could possibly be an element. However Novavax’s battle to fabricate doses on time might be a a lot greater issue. Novavax didn’t reply to a request for remark.
It’s not completely clear that Maryland-based Novavax has solved its manufacturing issues. We could possibly be about to seek out out. The variety of international locations the place Nuvaxovid has the inexperienced mild might improve in coming weeks, as well being regulators take a cue from the FDA and guess on Nuvaxovid’s extremely shelf-stable design to ease distribution and enhance native uptake.
There’s rather a lot that might go unsuitable.
To be clear, Nuvaxovid itself isn’t the issue. Novavax’s two-dose vaccine is each like and in contrast to the opposite main vaccines, together with the messenger-RNA jabs from Massachusetts-based Moderna and Pfizer in New Jersey.
The mRNA vaccines embody genetic directions that inform our immune techniques to supply antibodies and T-cells for attacking the novel-coronavirus’s spike protein, the a part of the virus that enables it to seize onto and infect our cells.
Nuvaxovid contains an engineered fragment of the spike protein itself—albeit one with out the genetic materials that causes precise illness.
It’s not a completely new method to vaccine design. There are comparable jabs for shingles, tetanus and different illnesses. However with its disease-free protein fragment, the Novavax vaccine stands out from the opposite COVID jabs.
It’s simply as efficient because the mRNA vaccines, stopping sickness in 90 % of instances, in line with the FDA. And since it’s extremely steady and doesn’t require intensive chilly storage like mRNA does, it’s rather a lot simpler to ship and retailer.
The mRNA vaccines go dangerous after lower than a day outdoors of a freezer. Nuvaxovid lasts six months beneath the identical circumstances. “The Novavax vaccine is far much less demanding,” Fei Wen, a chemical engineer on the College of Michigan, informed The Each day Beast.
That’s not terribly necessary in a wealthy nation with a complicated provide chain that includes loads of fridge vehicles and freezers. However it’s vastly necessary for some poor international locations which may not actually have a absolutely paved highway community, to say nothing of clinics with industrial freezers.
“Novavax does have some logistical benefits with cold-chain necessities that make it actually helpful in rural settings or low and middle-income international locations that battle with distribution chains,” James Lawler, an infectious illness skilled and a colleague of Wiley on the College of Nebraska Medical Heart, informed The Each day Beast. “For the worldwide vaccination marketing campaign, that could be a large deal.”
It’s these poorer international locations which might be most in want of vaccine proper now. Globally, 62 % of persons are absolutely vaccinated in opposition to COVID with two doses of mRNA or one dose of a single-shot jab such because the one from Johnson & Johnson. However in Africa, simply 18 % of persons are absolutely vaccinated.
Novavax might considerably enhance vaccine uptake in Africa, assuming financing comes via and manufacturing retains up.
The financing is sophisticated. International locations can minimize their very own offers with Novavax, in fact. However poorer international locations may also get jabs from COVAX, a world vaccine-distribution consortium with $11 billion in funding from richer international locations. COVAX has already ordered greater than 1 billion doses of Nuvaxovid.
However manufacturing is much more sophisticated than financing. And that’s the place Nuvaxovid might fizzle.
Novavax is a relatively small firm, with income totalling simply $1 billion in 2021. For comparability, Moderna logged $19 billion in gross sales the identical yr. Whereas it’s not unusual for even a wealthier pharmaceutical agency to outsource facets of drug-production, Novavax depends nearly completely on outdoors companies to fabricate doses.
That manufacturing dependency is one motive why it took so lengthy for Novavax to get the nod from the FDA, 20 months after the company accepted the primary COVID vaccine, Moderna’s, for distribution within the U.S. Novavax first utilized to the FDA for emergency use authorization in January. 5 months later, the FDA was nonetheless scrutinizing the corporate’s manufacturing plans.
The company had motive to be skeptical. Novavax shortly fell behind on its preliminary orders from earlier this yr, together with the massive COVAX deal and smaller gross sales to the Philippines and Indonesia.
“I conjecture among the delays on this explicit case have occurred as a result of it's a smaller firm, with out current merchandise, partnering with contract producers and with out as many current techniques,” Julie Swann, a techniques engineering professor and vaccine-distribution skilled at North Carolina State College, informed The Each day Beast.
The open query, for Novavax and its clients, is whether or not FDA authorization, and massive orders from the U.S. authorities, drives enhancements within the firm’s processes—or weighs the agency down.
Novavax’s largest subcontractors embody Baxter Worldwide in Illinois and Serum Institute of India. Consultants are cautiously optimistic that Baxter and Serum can scale up Nuvaxovid manufacturing. Extra vats for rising proteins. Extra strains for filling vials. Extra employees loading vehicles, trains and planes. “The companions that Novavax is working with to face up worldwide manufacturing are world-class in scaling organic manufacturing processes,” Lawler stated.
If the factories can begin churning out doses on time, the consequence could possibly be extra vaccinations within the international locations that want them probably the most.
If the factories fall additional behind, demand might collapse and Nuvaxovid might fail. That might be disastrous for Novavax. And even extra disastrous for lots of of thousands and thousands of individuals in poor international locations who nonetheless want entry to a very good COVID vaccine.