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, spWebicNewsing 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.
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 emerged in southern Africa and whose mutations have made it less 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. WEBICNEWS 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.