Navdeep
Novavax’s rise comes as pressure to increase the supply of Covid-19 vaccines is growing amid concerns that unequal access globally will extend the pandemic.
Hopes are growing that a dark-horse coronavirus vaccine from a tiny U.S. drugmaker can shore up supplies in the U.S. and globally as safety concerns and production problems shadow shots from Johnson & Johnson and AstraZeneca.
The vaccine’s developer, Novavax, has never brought a product to market. Its shot entered late-stage clinical trials months after candidates from bigger names like Pfizer and Moderna. However, the Novavax vaccine, now considered by some as the most promising COVID-19 vaccine, proved just as potent as those mRNA shots in a U.K. trial. The company is now preparing to file for U.S. authorization within weeks. This move could potentially allow it to leapfrog AstraZeneca, a former frontrunner.
Novavax’s rise comes as pressure to increase the supply of Covid-19 vaccines is growing amid concerns that unequal access globally will extend the pandemic. The company has pledged to provide 100 million doses of its shot to the U.S. later this year, after receiving $1.6 billion for development and manufacturing. It’salso one of a handful of manufacturers to promise significant deliveries worldwide, including 1.1 billion doses for low- and middle-income countries like India, where cases are skyrocketing.
The next few months will determine whether Novavax can overcome its bumpy start and deliver on those increasingly high expectations. The company has enlisted production partners worldwide after struggling to scrape together the tens of thousands of doses needed for its clinical trials. Those hired factories are still getting up to speed with Novavax’s vaccine technology, which uses moth cells to brew batches of the coronavirus spike protein. In non-pandemic times, such retrofitting can take years. The company is aiming to pump out 150 million doses a month by the second half of the year.
“I do think it’s going to play a larger role,” said Lawrence Gostin, a global health law professor at Georgetown University.“In the short to medium term, at least, the Johnson & Johnson vaccine has taken a reputational hit and people are more hesitant to take it. In addition, J&J has had major production problems at its Baltimore plant. And as a result I think Novavax is going to be a reasonably significant player.”
U.S. officials have not factored the vaccine into their Covid-19 response plans just yet, despite the early Phase III trial results from the U.K., released in March, that put the Novavax shot on par with vaccines from Pfizer and Moderna. The Biden administration still has questions. They want to know how quickly the company can scale up production. They also want to see if the company can fulfill the U.S. order for 100 million doses, said a senior official.
The administration’s caution stems in part from the recent troubles of Johnson & Johnson and AstraZeneca.
A J&J contractor contaminated 15 million doses of the company’s shot this spring. Halting U.S. production for the near future. Regulators in the U.S. and Europe have recently launched investigations into potential links between the J&J and AstraZeneca shots. Amid reports of rare but severe blood clots. The European Union has since opted out of purchasing further doses of either vaccine.
For the U.S., the Novavax shot could serve as an insurance policy in case supplies of the two mRNA vaccines — the workhorses of the country’s vaccination push — or the J&J shot falter. But many countries are not so fortunate. Thirty one percent of the billion vaccine doses administered worldwide have gone to North America, and just under 2 percent have gone to Africa.
India’s Serum Institute plans to produce over one billion doses of the Novavax vaccine this year. Most of these doses will go to COVAX. COVAX is a global effort to provide vaccines to the world’s poorest countries. COVAX organizers say they have deals for about 1.1 billion doses of the Novavax shot, nearly on par with their orders of the AstraZeneca vaccine.
By contrast, Pfizer has pledged only 40 million shots to COVAX this year. Moderna is still in talks with the facility. Many of their individual deals are with European countries. Johnson & Johnson has pledged 500 million doses of its one-shot vaccine to COVAX, but most of them are expected in the last three months of the year.
COVAX is relying on the Novavax vaccine. It aims to vaccinate at least 20% of people in participating countries by the end of the year. Mesfin Teklu Tessema, a senior director at the International Rescue Committee, said this. He is part of a civil society group for COVAX. He warned that any problems with Novavax would be a big setback for COVAX’s 2021 plans.
The Serum Institute plans to start stockpiling Novavax doses this month. Also seeks authorization for the vaccine in India as soon as the FDA clears it for use in USA. Meanwhile, South Korea aims to begin local production of the vaccine in June.
Gregory Glenn, Novavax’s president of research and development, spoke to POLITICO. He said the company has built one of the largest vaccine-production networks worldwide over the past year. It includes factories in Italy and the Czech Republic, and partnerships with South Korea and Japan’s Takeda Pharmaceuticals along with the Serum Institute deal.
But those efforts have run into manufacturing problems. In early March, Serum Institute CEO Adar Poonawalla warned about U.S. restrictions on raw materials like bags and filters. He said the limits could affect vaccine production. The policy has already slowed the company’s efforts to produce large quantities of the AstraZeneca shot. This comes as India reports world-record daily infection numbers.
After growing pressure and a surge of infections and deaths in India, the White House responded. On Sunday, it announced that it had found sources of raw materials. These will be sent to India to support vaccine production. But it is not clear how quickly the Serum Institute and others will be able to ramp up their output.
Earlier this month, Novavax CEO Stan Erck told the U.K.’s Observer about a major supply issue. A shortage of 2,000-litre bags used to grow vaccine cells had become a hurdle for global production. Still, Erck said he felt confident. He believed Novavax and its U.K. partners had enough bags to meet manufacturing needs.
The firm also faces questions about how well its vaccine touted. By some the most promising COVID-19 vaccine performs against key virus variants spreading worldwide. The Novavax shot was just 55.4 percent effective against the B.1.351 variant, first found in South Africa, during a mid-stage trial in that country. More data on the vaccine’s performance against different variants could be released when Novavax files for use in the U.S. or Europe.
Many experts view the mRNA technology behind the Pfizer and Moderna vaccines as the future. However, Novavax executives say their vaccine is easy to modify. They claim it can target different or multiple coronavirus strains.
They believe their shot—and others—will be needed for years. Health officials may call for boosters or updated versions to target new variants.
“Everyone will need to be boosted,” said Glenn. “This is a viral respiratory disease, and we know from the flu that immunity from an infection is good for maybe 12 months, 18 months, and after that people become susceptible again. After that, we’re going to have to boost.”
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