We have something between us and the Nuvaxovid COVID vaccine of our dreams

Novavax’s new COVID-19 vaccine is safe and effective. Even better, it’s easy to transport and store, making it ideal for poor countries that still have low incomes.

A shot by a company called Nuvaxovid could change the vaccine landscape as the pandemic rages into its 32nd month. More protection for more people against new, increasingly infectious variants of the SARS-CoV-2 virus.

Assuming Novavax can deliver a sufficient dose in time, that is. Manufacturing problems can derail the widespread adoption of new hardware.

The U.S. Food and Drug Administration on July 13 granted Nuvaxovid emergency use approval and approved the shot for Americans 18 and older. “The vaccine meets the FDA’s high standards of safety and efficacy for emergency use approval,” said Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation.

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

Forty countries, mostly in Europe, have already approved Nuvaxovid before FDA decision. But acceptance was low. This may be due to the large number of vaccine options and oversupply in Europe. But Novavax must have struggled to produce a timely dose bigger factor. Novavax did not respond to a request for comment.

It’s not clear that Maryland-based Novavax has solved its manufacturing problems. We may be close to finding out. The number of countries giving Nuvaxovid the green light could increase in the coming weeks as health regulators take advice from the FDA, betting on Nuvaxovid’s shelf-stable design to ease distribution and boost local acceptance.

There’s a lot that can go wrong.

Clearly, Nuvaxovid itself is not the problem. Novavax’s two-dose vaccine is both as such the and not the same other leading vaccines, including messenger-RNA kits from Massachusetts-based Moderna and New Jersey-based Pfizer.

mRNA vaccines contain the part of the new coronavirus protein that tells our immune systems to produce antibodies and T cells, allowing the virus to enter and infect our cells.

Although Nuvaxovid does not contain the genetic material that actually causes the disease, it contains an engineered fragment of the head protein.

This is not an entirely new approach to vaccine design. There are similar supplies for tetanus and other diseases. But with a disease-free protein fragment, the Novavax vaccine is different from other COVID vaccines.

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

mRNA vaccines deteriorate after less than a day out of the freezer. Nuvaxovid lasts six months under the same conditions. “The Novavax vaccine is not required,” Fei Wen, a chemical engineer at the University of Michigan, told The Daily Beast.

In an affluent country with a complex supply chain involving many refrigerated trucks and freezers, this is not critical. but it’s great Important for some poor countries that do not 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 low- and middle-income countries that struggle with distribution chains,” James Lawler, an infectious disease expert and Wiley colleague at the Nebraska Medical Center, told the Daily Beast. . “This is a big deal for the global vaccination campaign.”

Poor countries need vaccines the most right now. 62 percent of people worldwide have been fully vaccinated against COVID with a single dose, such as two doses of mRNA or one dose of Johnson & Johnson. However, only 18 percent of people in Africa are fully vaccinated.

If funding is forthcoming and production continues, Novavax could significantly increase vaccine uptake in Africa.

Funding is difficult. Of course, countries can cut their contracts with Novavax. But poor countries can still get COVAX from the International Consortium for Vaccine Distribution, which has $11 billion in funding from rich countries. COVAX has already ordered more than 1 billion doses of Nuvaxovid.

But production is more complicated than financing. That’s where Nuvaxovid can get annoying.

Novavax is a relatively small company, with total revenue of just $1 billion in 2021. By comparison, Moderna generated $19 billion in sales in the same year. While it’s not uncommon for wealthier pharmaceutical firms to outsource aspects of drug manufacturing, Novava relies almost entirely on outside firms to manufacture its doses.

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

The agency had reason to be suspicious. Novavax quickly fell behind its first orders earlier this year, including a large COVAX contract and lower sales to the Philippines and Indonesia.

“I think the reason for some of the delays in this particular case is that it’s a small company because it doesn’t have existing products, partners with contract manufacturers, and doesn’t have a lot of systems in place,” said Julie Swann, professor of systems engineering and vaccine distribution expert at North Carolina. state university told the Daily Beast.

The open question for Novavax and its customers is whether the FDA approval and large orders from the US government will spur improvements in the company’s processes or burden the firm.

Novavax’s largest subcontractors include Baxter International of Illinois and the Serum Institute of India. Experts are cautiously optimistic that Baxter and Serum will be able to expand production of Nuvaxovid. More containers for growing proteins. More lines to fill vials. Workers loading trucks, trains and planes. “The partners Novavax is working with to scale up international production are world-class in scaling biologics manufacturing processes,” said Lawler.

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

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

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