A looming shortage of doses for low- and moderate-income countries puts increased pressure on Novavax to obtain regulatory approvals for global manufacturing.
Novavax, using Serum Institute data, has won authorizations in India, Indonesia, the Philippines, Europe and with the WHO. | Tatan Syuflana/AP Photo
By ERIN BANCO, ADAM CANCRYN and SARAH OWERMOHLE
As the U.S., Europe and parts of Asia consume more booster doses than expected, global health advocates hope the emerging vaccine produced by Maryland-based Novavax will fill the supply gap in low- and middle-income countries in 2022.
But while Novavax — after partnering with India’s Serum Institute — obtained regulatory approvals from the World Health Organization and European Commission this month, crucial questions remain about both its ability to obtain Food and Drug Administration approval and to produce enough doses in manufacturing sites other than the Serum Institute.
Without sign-offs from world regulators to produce vaccines at its U.S. and European sites, Novavax could struggle to meet its 2022 targets, setting back the global vaccination effort, according to two senior officials working on the Biden administration’s international pandemic response.
If that happens, and countries across the world continue to roll out booster campaigns, U.S. officials fear the world might not have enough vaccine doses to meet the WHO’s goal of inoculating 70 percent of the global population by the middle of next year. Such a lapse would leave wide swathes of the world as fertile ground for the development of new variants, spawning repeat performances of the Omicron drama unfolding around the world.
“With the boosters, there is more unpredictability in the system, more unreliability in supply,” said Saad Omer, director of the Yale Institute for Global Health. “If there’s disruption of the doses already allocated for the next five to six months, then we have a problem.”
The WHO set its goal in September after the world failed to meet its initial target of vaccinating 10 percent of every country by the end of September. But now, top officials in the Biden administration are increasingly fearful that the latest goal, as well, will be in jeopardy.
Although Biden officials had repeatedly said U.S. can provide booster shots to all Americans without disrupting future donations, they now say more doses than previously expected could be consumed as other countries with already high levels of vaccination — such as those in Europe — ramp up the distribution of booster shots amid a sharp increase in Omicron cases.
The White House declined to comment. The Department of Health and Human Services did not respond to a request for comment.
The new concerns inside the Biden administration follow weeks of warnings by global health advocates who cautioned that booster rollouts ultimately lead to fewer shots for low- and middle-income countries where large portions of the population are still waiting for first doses.
“Blanket booster programs are likely to prolong the pandemic, rather than ending it, by diverting supply to countries that already have high levels of vaccination coverage,” WHO chief Tedros Adhanom Ghebreyesus told reporters Dec. 22.
Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. | Karen Ducey/Getty Images
The Biden administration has pledged 1 billion doses to the world in 2022, while COVAX, the global vaccine equity effort, is still waiting on other Western countries, including those in Europe, to pledge more doses for next year to help boost its stockpile. Meanwhile, COVAX and U.S. officials worry that as vaccine efficacy begins to wane, health officials in many nations will have to rejigger their calculations on how many doses are needed to increase protection at home. That could force countries to pull from pots originally earmarked for international distribution, delaying both the pace of donations and the drug makers’ ability to fulfill orders.
Countries across the globe, including the U.S., have signed contracts with vaccine makers that allow the governments to use doses publicly earmarked for donations for other domestic purposes, according to an individual with direct knowledge of the administration’s thinking on Novavax who is also familiar with the Biden administration’s vaccine contracts.
The supply problem could still be alleviated, the Biden officials said, if new vaccines become available after the turn of the year. Officials working with COVAX are gearing up to begin filling the gap with Novavax, whose protein-based shot has long been considered key to vaccinating the world.
Novavax has experienced monthslong delays stemming from difficulties manufacturing a high-quality shot in large batches. The company, which once predicted its vaccine would file for regulatory approval in the U.S. a year ago, is in the process of finalizing its request for emergency FDA authorization and is still seeking approval across the world for its shots manufactured at its U.S. and European facilities.
In the meantime, however, Novavax has partnered with the Serum Institute in India, one of the world’s largest and most established manufacturing hubs. By December, both the WHO and the European Commission approved the Novavax-Serum Institute product for emergency use. The shot, which does not require freezer storage, is much easier to ship to Africa — where most countries lack 15 percent immunization rate — than the mRNA vaccines of Pfizer-BioNTech and Moderna.
Scientists believe that achieving a higher level of inoculation in Africa is important to stop the emergence of new variants like Omicron, which first began spreading rapidly in southern Africa and whose mutations have made it more resistant to vaccines and sparked a worldwide surge of tens of millions of cases.
Novavax’s decision to apply for authorization using data only from the Serum Institute raises questions about the extent to which the company is still experiencing manufacturing problems in the U.S. and Europe. POLITICO previously reported that the company was failing to produce data that showed it could manufacture a shot with high purity levels in large batches. One of the main facilities that struggled is in Texas.
By SARAH OWERMOHLE, ERIN BANCO and ADAM CANCRYN
It is still unclear how many doses Novavax will be able to provide next year. A company spokesperson said its goal is to produce 2 billion doses in 2022. But there are lingering concerns among top Biden officials and global health advocates about Novavax’s manufacturing facilities in the U.S. and Europe and whether the company can present the data necessary to obtain the regulatory approvals necessary to distribute doses made at those locations any time soon, according to the individual with direct knowledge of the administration’s thinking on Novavax and another individual with direct knowledge of the company’s communications with the administration. Both sources requested to remain anonymous to speak more freely on the matter.
So far, the company has only received approval for doses made at the Serum Institute because officials there delivered data that showed the manufacturing facility could produce a top notch product consistently and in large amounts. The U.S. and European sites are still working on proving they can do the same.
The Serum Institute declined to answer questions about how many doses of its Novavax shot, called COVOVAX, it can produce per month or what percentage of the total projected 2 billion in 2022 could be produced at the institute. Calculations from earlier this year showed Novavax’s European and U.S. sites could produce up to about 25 million and 50 million doses a month respectively, according to a former U.S. official with knowledge of the matter.
But as of this fall, officials at the FDA still had significant concerns about Novavax’s data and its ability to produce a vaccine without a disproportionate level of impurities. Since that time, Novavax representatives have met with the FDA, a spokesperson for the company said, adding that it plans to file its updated and complete manufacturing data set by the beginning of 2022, after which it is expected formally request an emergency use authorization.
John Trizzino, the chief commercial and business officer of Novavax, told POLITICO in a statement that the company filed for authorizations using Serum Institute data because it was “the most expeditious path.”
“In the near future, we will supplement our submissions with manufacturing data from additional facilities across our global supply chain and are confident that our clinical and manufacturing data meet the stringent standards set by all regulatory agencies around the world,” Trizzino said.
The uncertainty about the global vaccine supply and Novavax’s production comes at a time when the Omicron variant is causing massive surges in infections and hospitalizations across the world. In the U.S., the variant has been detected in every state. While cases are decreasing in southern Africa numbers are increasing in parts of western Europe, including in France and the United Kingdom. Health officials have said the world should expect to see more upticks in January as the variant infects more of the unvaccinated and unboosted populations.
The WHO’s Covid-19 technical lead, Maria Van Kerkhove, told reporters earlier this month that the global health community expects more strains to emerge after Omicron — variants that will require that more doses be made available for international disbursement.
So far, about 9 billion shots have been administered across the globe, according to an analysis by Bloomberg. Researchers and statisticians at Duke University have previously calculated that the world needed 11 billion shots to vaccinate 70 percent of the world’s population — the target the WHO now sets for the middle of 2022.
The problem, global health advocates and Biden health officials said, is that the effectiveness of the vaccine is waning and the definition of fully vaccinated is being reconsidered. As Omicron continues to cause spikes in cases and hospitalizations in the U.S. and Europe, officials are beginning to recalculate how many doses they will need to protect their populations, meaning the 11 billion number could edge up in 2022.
It is difficult to tell exactly how many people have received two doses versus three in the U.S. and Europe — the data are messy because there is no accurate, real-time information that reflects those numbers. But billions of people in both regions are now eligible for the booster shot. That means the U.S. and large portions of Europe will need to make billions of shots available in 2022 for their own people. Officials and global health advocates fear there is not enough global manufacturing capacity to provide those shots while simultaneously providing billions of pledged doses to poorer countries in the first half of 2022.
In its December global supply forecast, COVAX said it should have as many as 2.4 billion doses on hand for distribution by March 2022. That number should be enough to allow COVAX to significantly ramp up its shipments to low- and middle-income countries in the beginning of the year. But that number in part hinges on Novavax’s ability to obtain the necessary regulatory permission for widespread distribution.
For more than a year, Novavax has had difficulties scaling its production. Some of its batches contained purity levels of as low as 30 percent — a quality far below the FDA’s typical standard of 90 percent, according to one of the individuals with direct knowledge of the administration’s thinking about Novavax.
The manufacturing problems frustrated officials on Operation Warp Speed, the Trump administration’s vaccine production initiative. In July 2020, the Trump team invested $1.6 billion to help Novavax deliver 100 million doses by the end of 2020. It was the largest investment by the federal government into any vaccine maker at the time.
Part of that investment was specifically geared toward helping the company find skilled workers who could help the company overcome its manufacturing snafus. But Novavax continued to struggle throughout 2021, missing benchmarks and targets it had publicly set for itself in 2020.
However, over the past several months, things have improved for the company. Novavax, using Serum Institute data, has won authorizations in India, Indonesia, the Philippines, Europe and with the WHO.
“Novavax remains wholly confident in the quality of our vaccine and our manufacturing processes, which continue to meet or exceed all regulatory and [global manufacturing practice] specifications,” Trizzino said. “We are now routinely producing high-quality product at commercial scale at multiple sites across the world.”
Global health advocates are hopeful that Novavax will help COVAX fulfill its vaccination pledges for 2022, particularly if it delivers on its production promises.
COVAX has signed a deal with the Serum Institute to purchase 300 million doses of the vaccine made at its facility — supply the global vaccine distributor expects to be made available in the early days of 2022, according to a spokesperson from Gavi, the group helping finance COVAX. COVAX has also signed a deal with Novavax for 350 million of its doses that are to be manufactured at its European facilities.
In addition, both the U.S. and Europe have ordered more than 300 million doses of the Novavax vaccine — shots that will likely come from production at European and American facilities. But it is not clear if any of these doses will be donated to low- and middle-income countries.
Despite the benefits of a Novavax vaccine coming online, the world still faces significant hurdles in getting shots off the tarmac and into arms.
“Vaccine companies haven’t been reliable partners. … They have treated [low and middle-income countries] and even COVAX as second-tier buyers and haven’t delivered on their promised doses with a lot of certainty,” Omer said. “This has led a lot of countries not to invest in their supply systems.”
By ERIN BANCO
USAID, the main agency overseeing the shipment and administration of American-made shots internationally, is seeking to expand its efforts to help countries better prepare to distribute doses and to do so equitably. But the agency is running out of money to help vaccinate the world.
In the meantime, as Novavax seeks approval for its European and U.S. sites and as the Biden administration attempts to quickly scale its Pfizer shipments to the rest of the world, WHO and other COVAX officials continue to advocate against broad booster rollouts, claiming that vaccine resources must go places where they’re needed the most.
“About 20 percent of all vaccine doses administered every day are currently being given as boosters or additional doses,” Ghebreyesus said in the Dec. 22 briefing. “Only half of WHO’s Member States have been able to reach the target of vaccinating 40 percent of their populations by the end of the year, because of distortions in global supply.”
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