As we enter the second year of the pandemic, all eyes are on the COVID-19 vaccination effort. In the U.S., the vaccine rollout has been plagued with logistical issues as states have been left to create their own distribution plans without adequate resources. Despite former President Donald Trump’s promise to vaccinate 20 million people by the end of 2020, only about 2.8 million Americans received the vaccine before the turn of the year. Upon taking office, President Joe Biden announced his goal to vaccinate 100 million people within his first 100 days of office, and last week, the U.S. government secured another 200 million doses to be delivered by the end of July.
In discussions of U.S. vaccine rollout, scarcity has been the major theme: There aren’t enough vaccines to meet demand, and people who need them most—health care workers, people of color, front-line workers, those over 65—can’t get access. But compared with much of the world, the U.S. is doing quite well. We’ve administered the most doses of any country, and are fifth when it comes to doses per capita. Meanwhile, many countries haven’t even begun their vaccinations, and the U.S. is making it harder for them. That additional 200 million doses the U.S. secured brings the country’s reserved vaccine dose count to 1.2 billion doses, according to data compiled by the Duke Global Health Innovation Center’s Launch and Scale Speedometer. There are currently 60 countries and multinational coalitions with confirmed reservations for vaccine doses; the U.S.’s share is greater than the combined reservation of 45 of those entities. For comparison’s sake, Pakistan’s population is roughly 68 percent of the U.S.’s, but its vaccine reservation is 17.5 percent of the U.S.’s.
“The [vaccine] scene globally is one of inequity, which is what we’ve been worried about for some time now,” says Krishna Udayakumar, founding director of Duke Global Health Innovation Center. When it comes to vaccine doses, it seems rich countries are only getting richer, squashing opportunities for less wealthy countries to access the vaccine. According to the Economist Intelligence Unit, some countries may not see a significant portion of their population vaccinated until 2024.
Like Udayakumar alluded to, global health experts have been anticipating this possibility since the beginning of the pandemic. In June, the World Health Organization, along with partners the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance, released a plan called COVAX to pool nations’ resources for developing and purchasing COVID-19 vaccines. At the time, investing in vaccine development was a risky proposition; it was a gamble whether any of the more than 100 vaccines in development would be safe, effective, and make it to market. COVAX allowed countries to pool resources and buy into a “portfolio approach”—their contribution bought into a pool of vaccine investments. “You could aggregate demand and use market power to get better prices for vaccines,” says Udayakumar. Once a vaccine was available, doses would be distributed to all participating countries at the same rate, based on their total population, according to a Gavi explainer written in September.
But as soon as promising vaccine trial results were released, rich countries directed their resources away from COVAX and toward pharmaceutical companies directly. “Rather than COVAX being the major platform purchasing vaccines, what we saw instead was that most countries in the world decided to go out and buy or reserve vaccine doses on their own bilateral deals,” says Udayakumar. Wealthier countries had the political and financial power to negotiate deals directly with Pfizer, Moderna, and AstraZeneca, often issuing emergency use orders that expedited the procurement process. Of the 8.2 billion confirmed vaccine doses purchased so far, more than 7 billion have come directly from such deals, with just 1.1 billion through COVAX. “There’s only so much capacity in the world to produce those vaccines, and that capacity was tied up by a few rich countries; there was nothing left over for the rest,” says Leena Menghaney, global intellectual property adviser for the Médecins Sans Frontières Access Campaign. To Menghaney’s point, the U.S. has individually secured more doses than COVAX. Our supply is nearly enough to vaccinate the entire U.S. population at least twice over and constitutes nearly 15 percent of the world’s total confirmed purchases.
These bilateral deals not only decrease immediate access to vaccine doses but also weaken COVAX’s negotiating and buying power. “Acquisition through bilateral agreements is to the exclusion of others,” says Safura Abdool Karim, a public health lawyer in South Africa and member of the African CDC’s African Vaccine Delivery Alliance. Pharmaceutical companies know they can strike big deals with wealthy countries directly, so they have little incentive to make deals with COVAX. As a result, vaccine doses are now concentrated primarily in North America and Europe. “By the middle of this year, you’ll have high-income countries vaccinating 30 to 40, even half of their population, while developing countries will still not barely reach 3 percent of the population,” says Menghaney. On Friday, the U.S. pledged to donate $4 billion to COVAX and encouraged other wealthy nations to do the same, but this came only after the country had already secured its own direct deals with companies.
These wealthy countries are also blocking another potential avenue to improve vaccine access: waiving intellectual property rights on COVID-related technologies. Most vaccine developers are private companies, so the vaccines are their intellectual property. There’s a long-standing debate about intellectual property in general in global health circles—while some point to IP as a way to provide incentives for investment in innovative products, there are downsides to giving companies all the power when it comes to vaccine manufacturing and distribution. IP can be a barrier for manufacturers that want to create generic versions of the vaccine, which could increase supply but, to big companies’ detriment, drive down their prices. Those generics would give buyers—in this case, countries—some leverage in negotiations with companies; they could realistically threaten to import generics or create their own, says Abdool Karim.
In October, India and South Africa called on the World Trade Organization’s Council for Trade-Related Aspects of Intellectual Property Rights, or TRIPS, to recommend that the organization issue a waiver freeing WTO member countries from having to implement copyright and patents on COVID-19 technology and products. The two countries cited an article in the Marrakesh Agreement, which established the WTO, that allows for the suspension of intellectual property rights in “exceptional circumstances.” (And what is this pandemic if not exceptional?) A month later, Kenya, Mozambique, Pakistan, and Eswatini signed on to the TRIPS waiver as co-sponsors, and according to Médecins Sans Frontières, 100 countries have “welcomed or fully supported the proposal.” But wealthy nations like the U.S., EU, Japan, and Australia have opposed it. “Countries and pharma companies work together; that’s been the story of Pfizer and the U.S., Bayer in Germany,” says Menghaney. “[Governments] see this as undermining commercial interests of companies.” The waiver proposal will be discussed at the next meeting of the Council on TRIPS on Tuesday.
If the WTO does invoke a TRIPS waiver—which some experts, like Udayakumar, are not optimistic about—the change won’t result in more vaccine capacity immediately. Even if IP rights are waived, vaccines won’t be made overnight; investments in manufacturing capacity, like buildings, machinery, and trained workers will take months, if not years, to pay out.
The continuing vaccine scarcity has left countries scrambling for any doses they can procure. As countries become more desperate, they’re considering a wider pool of vaccines than before. “Those have varying levels of transparency in the data behind them but have gone through, to date, less regulatory scrutiny than others,” says Udayakumar. (In particular, Russia’s Sputnik V and China’s Sinopharm vaccines have been popular but controversial choices.)
In South Africa, for instance, the issue of vaccine supply has become a hugely political issue, says Abdool Karim. As countries like Hungary and Egypt have bought millions of these less-vetted vaccines, the South African public is wondering why its government wasn’t more proactive about buying doses—but such discussions don’t always include the nuances of which vaccines are available and whether those that are would pass regulatory scrutiny. In the midst of this criticism, the South African government pivoted away from using AstraZeneca’s vaccine after evidence emerged that it could be less effective against the 501Y.V2 variant. It has also announced it would begin administering the still-unapproved Johnson & Johnson vaccine to health care workers as part of a study. In addition to an initial batch of 80,000 doses, the country has secured at least 9 million more.
But the number of doses available is just one factor in the race to secure vaccines; countries and regional coalitions are also trying to find ways to boost their position in the vaccine distribution queue. “It’s starting to matter less whether you purchased 100 million doses or 10 million doses, and [more] when are you in the queue for delivery relative to others who have purchased,” says Udayakumar. How, exactly, countries are negotiating this is opaque because those terms are laid out in contracts, but details available to the public indicate that the timing of vaccine delivery drives countries’ political moves. “We saw some of this play out publicly in the spat between the EU and the U.K., where AstraZeneca had to reduce supply to the EU because of manufacturing challenges in their EU-based plant,” says Udayakumar. “We’re also starting to see the purchase of vaccines with specific dates in mind,” like the African Union negotiating deals with Pfizer, Johnson & Johnson, and AstraZeneca for delivery of 670 million doses, with distribution to begin in the next few weeks.
As the pandemic drags on, questions about equitable vaccine distribution and IP will only become more important. With new variants, it’s possible vaccines will require boosters or the development of a seasonal vaccination, which means we’ll need to hone existing systems for vaccine distribution. “It’s hard enough to say we need to get one round of vaccinations out to almost everyone in the world, but orders of magnitude more difficult to say we need to do that over and over,” says Udayakumar. “We’re going to have to see through these investments in manufacturing and make sure we’re scaling up all our other resources, including supply chain access to train workforce, all the supplies, data systems to track who has received vaccines and who hasn’t.”
And to take an even longer lens on vaccine equity, it’s important to remember that resources put toward the issue are finite. For the past year, the world has diverted significant resources toward tackling COVID’s challenges, often to the neglect of other public health challenges. “It’s not just about this pandemic for resource constrained countries; it’s actually about the fragility and protection of their overall health care system and the health and well-being of their entire population,” says Abdool Karim. “What’s the long-term impact of a pandemic when there’s a whole system being strained?”