The next few months will determine whether Novavax can get out of its bumpy start and meet these increasingly higher expectations. The company has gained manufacturing partners around the world after struggling to scrape together the tens of thousands of doses needed for its clinical trials. These rented factories are still up to date with Novavax’s vaccine technology, which uses moth cells to brew batches of the coronavirus spike protein. In times without a pandemic, such retrofitting can take years. The company aims to pump 150 million cans a month by the second half of the year.
“I think it’s going to play a bigger role,” said Lawrence Gostin, professor of global health law at Georgetown University. “At least in the short to medium term, the Johnson & Johnson vaccine has suffered a loss of reputation and people are more reluctant to take it. In addition, J&J was experiencing major production problems at its Baltimore facility. As a result, I think Novavax will be a reasonably significant player. “
U.S. officials have not yet included the vaccine in their Covid-19 response plans despite early results from the UK Phase III study released in March that equated the Novavax shot with vaccines from Pfizer and Moderna. The Biden administration still has questions about how quickly the company can ramp up production and meet the US 100 million dose order, a senior administration official said.
The government’s caution is based in part on recent problems at Johnson & Johnson and AstraZeneca.
A J&J contractor contaminated 15 million cans of the company this spring, shutting down U.S. production for the near future. Regulators in the US and Europe have recently opened investigations into possible links between the J&J and AstraZeneca shots, which are reporting reports of rare but severe blood clots. The European Union has since declined to buy more doses of both vaccines.
For the U.S., the Novavax shot could serve as an insurance policy in the event that delivery of the two mRNA vaccines – the workhorses of the country’s vaccination surge – or the J&J shot stalled. But many countries are not so lucky. Thirty-one percent of the billions of vaccine doses administered worldwide went to North America and just under 2 percent went to Africa.
India’s Serum Institute is expected to produce More than a billion doses of Novavax have been given that year. Most of these went to COVAX, the global vaccine investment that aims to serve the world’s poorest countries. COVAX organizers say they have offers for about 1.1 billion cans of the Novavax shot, almost on par with their orders for the AstraZeneca vaccine.
In contrast, Pfizer has only pledged 40 million admissions to COVAX this year, and Moderna is still in talks with the facility. Much of their individual business concerns European countries. Johnson & Johnson has promised 500 million doses of its one-shot vaccine to COVAX, but most of these are expected in the final three months of the year.
COVAX is counting on Novavax’s shot to achieve its goal of providing vaccines to at least a fifth of the population of participating countries by the end of the year, said Mesfin Teklu Tessema, senior director of the International Rescue Committee, member of a civil society working group for COVAX . “If that [would] Given the challenge, this would be a huge setback for COVAX in terms of dispensing cans in 2021, ”he said.
The Serum Institute plans to start stocking up Novavax is dosing this month and could file for approval for the vaccine in India once the FDA clears it for use in the US. Meanwhile South Korea aims to start local production of the vaccine in June.
Gregory Glenn, President of Research and Development at Novavax, told POLITICO that the company had built one of the largest vaccines– –Production networks worldwide last year. It includes factories in Italy and the Czech Republic, as well as partnerships with South Korea and Japan’s Takeda Pharmaceuticals, as well as the contract with the Serum Institute.
However, these efforts encountered manufacturing problems. Adar Poonawalla, CEO of the Serum Institute Warned in early March that a temporary US restriction could restrict raw materials like bags and filters its ability to produce the shot. The directive has already hampered the company’s attempt to pump out as many doses of the AstraZeneca vaccine as possible, while India reports world record numbers of infections on a daily basis.
After pressure in the middle a wave of infections and deaths that has overwhelmed hospitals and crematoria in India, the White House said on Sunday that it has found some raw material sources that will be made available to India for vaccine production. However, it is not clear how quickly the Serum Institute and others can increase their production.
And earlier this month, Novavax CEO Stan Erck said the UK observer That a shortage of 2,000 liter bags in which the vaccine cells were grown represents a significant hurdle for global supply. Even so, Erck said he was confident the company and its manufacturing partners in the UK had enough pockets to make the vaccine.
The company is also faced with questions about how well its vaccine works against virus variants that are common around the world. The Novavax shot was only 55.4 percent effective against the B.1.351 variant, which was first found in South Africa during an interim test in that country. Further data on the performance of the vaccine against different variants could be released when Novavax is submitted for use in the US or Europe.
While many experts view the nimble mRNA technology underlying Pfizer and Moderna vaccines as the way forward, Novavax executives believe that it is relatively easy to modify their vaccine to target different ones or targets multiple strains of coronavirus.
They are betting on the likelihood that their shot and many others will be needed for years to come as health officials look for boosters or changes that target variants.
“Everyone needs to be empowered,” said Glenn. “This is a viral respiratory disease, and we know from the flu that immunity to infection is good for maybe 12 months, maybe 18 months, and then people become vulnerable again. After that we have to improve. “