Novavax missed its global moonshot but is angling to win over mRNA defectors

Novavax hitched its wagon to the global coronavirus pandemic. Earlier than most People actually grasped the scope of the hazard, the small Maryland biotech startup had secured $1.6 billion in U.S. funding for its covid vaccine. Its moonshot purpose: delivering 2 billion pictures to the world by mid-2021.

Though the U.S. dedication ultimately expanded to $1.8 billion, hardly any Novavax pictures have discovered arms due to manufacturing points, and a lot of the world has moved on. Novavax inventory has plummeted from $290 a share in February 2021 to round $50 just lately.

The FDA lastly seems poised to authorize the corporate’s vaccine, nevertheless. If it does, Novavax would goal the tens of hundreds of thousands of People who should not vaccinated in opposition to covid-19 or would profit from boosters but have prevented mRNA vaccines due to well being considerations or conspiracy theories about their risks.

In scientific trials, Novavax’s two-dose vaccine has labored properly and had few security issues. It seems to trigger fewer disagreeable reactions — fever, chills, and exhaustion — related to mRNA vaccines produced by Moderna and Pfizer-BioNTech.

Novavax additionally depends on a extra time-tested expertise, utilizing recombinant proteins grown in cell cultures. An influenza vaccine produced a lot the identical method as Novavax’s shot has been in the marketplace in america for almost a decade.

“I do suppose there is a minority group who would take a protein vaccine over an mRNA vaccine,” mentioned Dr. Kathleen Neuzil, director of the Heart for Vaccine Growth and Global Well being on the College of Maryland. She was a researcher in a significant U.S. trial of the Novavax vaccine, which discovered it 100% efficient at stopping something worse than delicate covid.

With the FDA’s authorization, Novavax’s product could be the primary vaccine produced in India for U.S. consumption. Novavax turned to the Serum Institute of India, a seasoned producer that makes vaccines for poor international locations, when its subcontractor in Texas, Fujifilm Diosynth Biotechnologies, stopped producing the vaccine final summer season after it was dinged by FDA inspectors for insufficient contamination management, lacking information, and different issues.

Based in 1987, Novavax has by no means marketed a vaccine in america. It has boasted in regards to the potential of a secret proprietary ingredient, Matrix-M, an immune system booster derived from Chilean soapbark timber. Those that’ve noticed the corporate’s string of failures over the previous decade see its June 7 FDA advisory committee assembly because the final likelihood to market its covid vaccine right here, though it has obtained greater than $2 billion in contracts with the U.S. authorities and nonprofit organizations.

Pharma giants Sanofi and GSK are collectively creating an identical vaccine. European Union reviewers started an examination of the drugmakers’ vaccine in March, and the businesses count on to request an FDA overview “in coming weeks,” Sanofi spokesperson Sally Bain mentioned.

Even with FDA authorization, Novavax could also be too late. Whereas its vaccine is licensed in 41 international locations and not less than 42 million doses have been distributed, the world is overstocked with covid vaccine.

“They’re making use of for an emergency authorization” from the FDA, mentioned Manon Cox, a vaccine business marketing consultant and the previous CEO of Protein Sciences Corp., which made an identical vaccine. “What is the emergency?”

Demand for covid vaccines is sluggish all over the place. About 13 million doses of the Novavax vaccine had been distributed in European Union international locations as of mid-April, but fewer than 200,000 had been administered. Distribution of the vaccine has been negligible since then.

Gavi, a nongovernmental group, has suspended a 2021 settlement to purchase not less than 350 million Novavax doses for the COVAX program, which distributes vaccines at a deep low cost to poor international locations.

The U.S. market, nevertheless, exhibits promise for Novavax’s shot instead to mRNA vaccines, particularly now that the FDA has restricted using a fourth vaccine, made by Johnson & Johnson, due to a critical although uncommon security danger.

“The anti-vaxxers have been getting increasingly aggressive about mRNA vaccine security, together with in current months claiming these vaccines trigger AIDS,” mentioned John Moore, a professor of microbiology and immunology at Weill Cornell Drugs. “It is all utter BS. But some individuals do purchase into this rubbish.”

Neuzil mentioned the Novavax shot may show extra sturdy than the mRNA pictures, whose capability to stop an infection appears to fade after a number of months, though they’re efficient at preserving individuals out of the hospital.

“Realistically, there in all probability aren’t that many unvaccinated individuals who will now determine to take Novavax,” Moore mentioned. “Being unvaccinated is largely down to politics, not science, sadly.”

Many of the demand could be for boosters. However the FDA has indicated Novavax’s pictures could be licensed initially as a primary dose, not a booster, John Trizzino, Novavax’s chief industrial officer, advised KHN in an interview. FDA officers even have bruited the potential for requiring vaccine producers to modify their pictures by this fall to goal the omicron variant.

Novavax has information exhibiting its shot successfully boosts individuals who acquired mRNA vaccines, Trizzino mentioned. And though the corporate is skeptical in regards to the want to modify its shot, Novavax just lately started testing an omicron-targeted vaccine and expects ends in late summer season, he mentioned.

It is stunning that Novavax ought to face this quandary now. The corporate introduced Might 9 that it had made its first-ever quarterly revenue, of $203 million on $586 million in vaccine gross sales.

Novavax expects income of $4 billion to $5 billion this yr in global gross sales, Trizzino mentioned, noting “this is not only a pandemic query, it is an ongoing vaccination query.” At an April 6 assembly, federal officers strongly steered that covid vaccination will develop into an annual suggestion, just like the flu shot.

“We had been barely behind offering provide into the pandemic interval, sadly,” Trizzino mentioned, “but there’s going to be not less than some sort of annual revaccination.”

Trizzino mentioned the corporate was negotiating with U.S. officers on how a lot of the rest of its $1.8 billion contract would pay for pictures as opposed to analysis. Past the contract, Novavax can cost the U.S. authorities a better per-unit value for added vaccine, he mentioned.

The Biden administration’s price range accommodates no point out of additional Novavax contracts, but if federal purchases finish, Novavax may promote on the industrial market. Medicare officers have set the worth for covid vaccines at about $60 per dose — roughly thrice what Novavax has been getting from the U.S. and European authorities patrons, Trizzino mentioned.

The corporate has come a great distance from its first product, a microscopic fats particle designed to encase vaccines that as a substitute was employed in skincare merchandise and Woman Scout cookies, in accordance to “The First Pictures,” an account by journalist Brendan Borrell. Novavax spent tons of of hundreds of thousands to develop a vaccine in opposition to respiratory syncytial virus, an an infection that is particularly dangerous to infants and the aged, but the product failed in 2016, after the corporate brushed apart a design function originating within the Nationwide Institutes of Well being laboratory of Dr. Barney Graham. That function, which entails shaping the viral protein to permit the immune system to higher acknowledge it, is now a key a part of all of the U.S. covid vaccines, together with the Novavax shot.

In 2019, Novavax bought its vaccine manufacturing facility and laid off all but about 100 staff. A yr later it was revived by Operation Warp Velocity, the large public-private effort to produce covid vaccines.

To make its shot, the corporate genetically alters an insect virus referred to as a baculovirus to produce covid proteins in moth cells. The system was developed by Gale Smith, first at Protein Sciences Corp., which used it to license an influenza vaccine. Sanofi in 2017 purchased Protein Sciences and its vaccine.

Smith, who has labored at Novavax since 2003, noticed the moth cell system as a safer, quicker various to conventional strategies of rising vaccine viruses in eggs or monkey and canine kidney cell cultures, which had been susceptible to contamination with probably harmful viruses. Baculoviruses do not develop in individuals.

However the baculovirus system is messy, in accordance to Kevin Gilligan, a senior marketing consultant at Biologics Consulting Group in Alexandria, Virginia, and a former federal pandemic preparedness official. The product of the moth cell bioreactors is usually a sticky combination of mobile particles, and bug and viral proteins.

“It is an entire soup of all types of issues,” Cox mentioned. “You undergo a purification course of and hopefully find yourself with that 90-plus p.c pure protein you need.”

In accordance to one report, some tons produced on the Texas plant had been solely 70% pure. So Novavax turned to the Serum Institute of India, certainly one of a number of firms within the U.S., Asia, and Europe with which it had signed manufacturing agreements in 2020.

Within the meantime, Novavax’s executives reaped document payouts in 2020. CEO Stanley Erck received $48 million, largely in shares and bonuses, whereas Trizzino and others received payouts of $20 million or extra every. Over the previous yr, firm executives cashed out shares price greater than $150 million.

Shareholders have sued Novavax over sagging inventory costs following missed deadlines for its vaccine.

In June 2021 Novavax employed a number one course of engineer, Indresh Srivastava, from Sanofi. The corporate’s manufacturing issues are “properly previous us,” Trizzino mentioned.

In an uncommon twist, whereas U.S. taxpayers could come to depend on the Indian model of a vaccine they closely funded, one other Indian firm, Organic E, is making a vaccine invented by Peter Hotez, Maria Elena Bottazzi, and colleagues at Baylor School of Drugs. Their solely authorities funding was a $400,000 NIH grant, Hotez mentioned, and Baylor is giving the shot away to firms that may make it cheaply in lower-income international locations.

About 45 million doses of the vaccine have been administered up to now to Indian teenagers — with a price to the Indian authorities of $1.86 per shot.

KHN correspondent Rachana Pradhan contributed to this report.