Novavax has taken his wagon to a global coronavirus epidemic. Before most Americans realized the real danger, the small Maryland biotech startup secured $ 1.6 billion in US funding for its covid vaccine. Its moonshot goal: to deliver 2 billion shots worldwide by mid-2021.
Although U.S. commitments have finally expanded to 1.8 billion, hardly any Novavax shot weapons have been found due to production problems, and much of the world has moved on. Novavax stock has recently dropped to around $ 50 from $ 290 per share in February 2021.
The FDA appears to be finally ready to approve the company’s vaccine. If so, Novavax will target millions of Americans who have not been vaccinated against Covid-19 or would have benefited from the booster but have avoided mRNA vaccines because of health concerns or conspiracy theories about their dangers.
In clinical trials, Novavax’s two-dose vaccine worked well and there were some safety issues. It is associated with the mRNA vaccine produced by Moderna and Pfizer-BioNTech – less unpleasant reactions – which appear to cause fever, chills and fatigue.
Novavax relies on more time-tested technologies using recombinant proteins grown in cell cultures. An influenza vaccine has been marketed in the United States for almost a decade, similar to the shot of NovaVax.
“I think there is a minority group who would receive a protein vaccine rather than an mRNA vaccine,” said Dr. Kathleen Newzil, director of the Center for Vaccine Development and Global Health at the University of Maryland. He was a researcher in a large US trial of the Novavax vaccine, which found it to be 100% effective in preventing anything worse than mild covid.
With FDA approval, the NovaVax product will be the first vaccine produced in India for US use. NovaVax serum goes back to the Institute of India, a seasoned manufacturer of vaccines for poorer countries, while its subcontractor in Texas, Fujifilm Diosynth Biotechnologies, in the wake of inadequate pollution control, closed FDA inspections for missing records, Makes, and other problems.
Founded in 1987, Novavax has never marketed a vaccine in the United States. It boasts of the potential to increase immunity to a secret proprietary ingredient, Matrix-M, derived from the Chiban soap tree. Those who have watched the company’s string of failures over the past decade see the June 7 FDA advisory committee meeting as the last chance to market the covid vaccine here, even though it has struck more than $ 2 billion in deals with the U.S. government and nonprofits. .
Pharma giant Sanofi and GSK are jointly developing a similar vaccine. Sanofi spokeswoman Sally Bain said EU reviewers had begun testing a vaccine for drug manufacturers in March and that companies were expected to request an FDA review “in the coming weeks”.
Even with FDA approval, Novavax can be too late. Although the vaccine is licensed in 41 countries and at least 42 million doses have been distributed, the world has a huge stockpile of covid vaccines.
“They’re applying for urgent approval from the FDA,” said Manon Cox, a vaccine industry consultant and former CEO of Protein Sciences Corporation, which has developed a similar vaccine. “What’s the emergency?”
Demand for this specialty has grown significantly as a result of recent corporate scandals. About 13 million doses of the Novavax vaccine were distributed to EU countries by mid-April, but less than 200,000 doses were delivered. Vaccine distribution has been negligible since then.
Gavi, a non-governmental organization, has postponed a 2021 deal to buy at least 350 million Novavax doses for the COVAX program, which distributes vaccines at deep discounts to poor countries.
The U.S. market, however, shows promise to take shots of Novavax as an alternative to the mRNA vaccine, especially now that the FDA has restricted the use of the fourth vaccine, developed by Johnson & Johnson, because of a serious but rare safety risk.
John Moore, a professor of microbiology and immunology at Weil Colonel Medicine, said: “Anti-vaccinators are becoming more aggressive about the safety of the mRNA vaccine, which has been claimed in recent months to cause AIDS.” “It simply came to our notice then. But some people buy this garbage. ”
Newsile said the Novavax shot may prove more durable than the MRNA shot, whose ability to resist infection fades after a few months, although they are effective in keeping people out of the hospital.
“In fact, there are probably not many immunized people who would decide to take NovaVax now,” Moore said. “Sadly, for most politicians not vaccinated, it’s not science.”
Most of the demand will be for boosters. But the FDA has indicated that Novavax shots will initially be approved as a first dose, not a booster, Novavax chief commercial officer John Trezino told KHN in an interview. FDA officials have also ruled out the possibility that vaccine makers may need to revise their shots this fall to target the Omicron variant.
NovaVax has data that shows its shots effectively encourage people to receive the mRNA vaccine, Trigino said. And while the company is skeptical about the need to correct its shots, NovaVax has recently begun testing an omicon-targeted vaccine and expects results by the end of the summer, he said.
It’s amazing that NovaVax has to deal with this problem now. The company announced on May 9 that it had a first-quarter profit of $ 203 million on িন 586 million in vaccine sales.
NovaVax expects থেকে 4 billion to $ 5 billion in global sales this year, Trigino said, “It’s not just an epidemic question, it’s an ongoing vaccination question.” At an April 6 meeting, federal officials strongly suggested that the Covid vaccine would become an annual recommendation, similar to the flu shot.
“Unfortunately, we were a bit late in delivering supplies during the epidemic,” Trigino said, “but there is going to be at least some kind of annual restoration.”
Trigino said the agency was in talks with U.S. officials about how much of the rest of its $ 1.8 billion contract would pay for the shots, contrary to research. Outside of the deal, NovaVax could offer the U.S. government a higher price per unit for additional vaccines, he said.
There is no mention of a further Novavax deal in the Biden administration’s budget, but once the federal purchase is completed, Novavax may be sold on the commercial market. Medicare officials have set the price of the Covid vaccine at around $ 60 per dose – about three times what Novavax is receiving from US and European government buyers, Trigino said.
According to an account by journalist Brendan Borel, “The First Shots”, the company has come a long way from its first product, a microscopic fat particle designed to block vaccines that were instead employed in skin care products and the Girl Scout cookie. NovaVax has spent millions to develop a vaccine against the respiratory syncytial virus, an infection that is particularly harmful to children and adults, but the product failed in 2016, when the company removed a design feature that emerged at the National Institutes of Health Laboratory. Dr. Barney Graham. That feature, which makes up the viral protein so that the immune system can recognize it better, is now a key component of all U.S. covid vaccines, including the Novavax shot.
In 2019, Novavax sold its vaccine production facility and laid off all but about 100 employees. A year later it was revived by Operation Warp Speed, a huge public-private effort to create the covid vaccine.
To make its shot, the company genetically modified an insect virus called Baculovirus to produce covid proteins in insect cells. The system was developed by Gall Smith, first at the Protein Sciences Corporation, which used it to license an influenza vaccine. In 2017, Sanofi bought Protein Sciences and its vaccines.
Smith, who has worked at NovaVax since 2003, sees the moth cell system as a safe, fast alternative to the traditional method of vaccine virus growth in egg or monkey and dog kidney cell cultures that are at risk of being infected by a potentially dangerous virus. Baculovirus does not grow in humans.
According to Kevin Gilligan, senior consultant at the Biology Consulting Group in Alexandria, Virginia, and former federal epidemiology officer, the baclovirus system is messy. The product of moth cell bioreactors can be a sticky mixture of cellular debris and insect and viral proteins.
“It’s a whole soup of all sorts of things,” Cox said. “You go through a refining process and hopefully end up with the 90-plus percent pure protein you want.”
According to a report, some of the lots produced at the Texas plant were only 70% pure. So Novavax is back at the Serum Institute of India, one of several companies in the United States, Asia and Europe with which it signed a manufacturing agreement in 2020.
Meanwhile, NovaVax executives have hit record payouts in 2020. CEO Stanley Erk received $ 48 million, mostly as stocks and bonuses, while Trigino and others received $ 20 million or more in payouts. Last year, the company’s executives cashed out more than $ 150 million worth of stock.
Shareholders have sued Novavax for dropping stock prices after it missed the deadline for its vaccine.
In June 2021, Novavax hired Indresh Srivastava, a leading process engineer from Sanofi. The company’s production problems are “past us,” Trizzino said.
In an unusual twist, while U.S. taxpayers may come to rely on Indian versions of their heavily funded vaccines, another Indian company, Biological E, is developing a vaccine invented by Peter Hotz, Maria Elena Botazzi and colleagues at the Baylor College of Medicine. . Their only government fund was a I 400,000 NIH grant, Hotez said, and Baylor is giving shots to companies that would make it cheaper in low-income countries.
About 45 million doses of the vaccine have been administered to Indian adolescents so far – costing the Indian government শ 1.86 per shot.
KHN correspondent Rachna Pradhan contributed to this report.
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