Novavax hitched its wagon to the worldwide coronavirus pandemic. Earlier than most Individuals 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 aim: 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 resulting from 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, nonetheless. If it does, Novavax would goal the tens of thousands and thousands of Individuals who should not vaccinated towards covid-19 or would profit from boosters however have averted mRNA vaccines due to well being considerations or conspiracy theories about their risks.
In medical trials, Novavax’s two-dose vaccine has labored effectively 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 means as Novavax’s shot has been available on the market in the US for practically a decade.
“I do assume there’s 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 International Well being on the College of Maryland. She was a researcher in a major 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 nations, when its subcontractor in Texas, Fujifilm Diosynth Biotechnologies, stopped producing the vaccine final summer time after it was dinged by FDA inspectors for insufficient contamination management, lacking information, and other problems.
Based in 1987, Novavax has by no means marketed a vaccine in the US. 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 probability 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 the same vaccine. European Union reviewers began 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 nations 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 guide and the previous CEO of Protein Sciences Corp., which made the same vaccine. “What’s the emergency?”
Demand for covid vaccines is sluggish in all places. About 13 million doses of the Novavax vaccine had been distributed in European Union nations as of mid-April, however fewer than 200,000 were 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 nations.
The U.S. market, nonetheless, exhibits promise for Novavax’s shot as a substitute for mRNA vaccines, particularly now that the FDA has limited the use of a fourth vaccine, made by Johnson & Johnson, due to a severe although uncommon security danger.
“The anti-vaxxers have been getting increasingly aggressive about mRNA vaccine security, together with in latest months claiming these vaccines trigger AIDS,” mentioned John Moore, a professor of microbiology and immunology at Weill Cornell Medication. “It’s all utter BS. However some individuals do purchase into this rubbish.”
Neuzil mentioned the Novavax shot might 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 maintaining individuals out of the hospital.
“Realistically, there most likely aren’t that many unvaccinated individuals who will now determine to take Novavax,” Moore mentioned. “Being unvaccinated is usually right down to politics, not science, sadly.”
Many of the demand could be for boosters. However the FDA has indicated Novavax’s pictures could be approved initially as a primary dose, not a booster, John Trizzino, Novavax’s chief industrial officer, advised KHN in an interview. FDA officers additionally have bruited the possibility of requiring vaccine producers to switch their pictures by this fall to focus on the omicron variant.
Novavax has information displaying its shot successfully boosts individuals who obtained mRNA vaccines, Trizzino mentioned. And though the corporate is skeptical about the necessity to modify its shot, Novavax just lately started testing an omicron-targeted vaccine and expects ends in late summer time, he mentioned.
It’s shocking that Novavax ought to face this quandary now. The corporate introduced Could 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 world gross sales, Trizzino mentioned, noting “this isn’t only a pandemic query, it’s an ongoing vaccination query.” At an April 6 meeting, federal officers strongly instructed that covid vaccination will change into an annual advice, just like the flu shot.
“We have been barely behind offering provide into the pandemic interval, sadly,” Trizzino mentioned, “however there’s going to be not less than some form 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 versus analysis. Past the contract, Novavax can cost the U.S. authorities the next per-unit value for added vaccine, he mentioned.
The Biden administration’s budget comprises no point out of additional Novavax contracts, but when federal purchases finish, Novavax might promote on the industrial market. Medicare officers have set the value for covid vaccines at about $60 per dose — roughly 3 times what Novavax has been getting from the U.S. and European authorities consumers, Trizzino mentioned.
The corporate has come a good distance from its first product, a microscopic fats particle designed to encase vaccines that as an alternative was employed in skincare merchandise and Lady Scout cookies, in line with “The First Shots,” an account by journalist Brendan Borrell. Novavax spent lots of of thousands and thousands to develop a vaccine towards respiratory syncytial virus, an an infection that’s particularly dangerous to infants and the aged, however 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 includes shaping the viral protein to permit the immune system to raised acknowledge it, is now a key a part of all of the U.S. covid vaccines, together with the Novavax shot.
In 2019, Novavax offered its vaccine manufacturing facility and laid off all however about 100 staff. A yr later it was revived by Operation Warp Pace, the large public-private effort to provide covid vaccines.
To make its shot, the corporate genetically alters an insect virus referred to as a baculovirus to provide 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 different to conventional strategies of rising vaccine viruses in eggs or monkey and canine kidney cell cultures, which have been liable to contamination with probably harmful viruses. Baculoviruses don’t develop in individuals.
However the baculovirus system is messy, in line with Kevin Gilligan, a senior guide at Biologics Consulting Group in Alexandria, Virginia, and a former federal pandemic preparedness official. The product of the moth cell bioreactors could be a sticky combination of mobile particles, and bug and viral proteins.
“It’s a complete soup of every kind 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 line with one report, some lots produced at the Texas plant have been solely 70% pure. So Novavax turned to the Serum Institute of India, certainly one of a number of corporations within the U.S., Asia, and Europe with which it had signed manufacturing agreements in 2020.
Within the meantime, Novavax’s executives reaped report payouts in 2020. CEO Stanley Erck acquired $48 million, largely in shares and bonuses, whereas Trizzino and others acquired payouts of $20 million or extra every. Over the previous yr, firm executives cashed out stocks 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 “effectively 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 Faculty of Medication. Their solely authorities funding was a $400,000 NIH grant, Hotez mentioned, and Baylor is giving the shot away to corporations that can make it cheaply in lower-income nations.
About 45 million doses of the vaccine have been administered thus far to Indian teenagers — with a cost to the Indian government of $1.86 per shot.
KHN correspondent Rachana Pradhan contributed to this report.