The World’s Best Hope to End the Pandemic Still Needs More Doses

(Bloomberg Businessweek) -- On Jan. 23, 2020, the day the novel coronavirus forced the Chinese city of Wuhan into lockdown, two American doctors named Seth Berkley and Richard Hatchett met at the bar of the Hard Rock Hotel in Davos, Switzerland, to talk about vaccines..At that point it wasn’t clear how soon, or even whether, effective vaccines for the disease caused by the virus could be developed. But Berkley, an epidemiologist who runs Gavi, a nonprofit that delivers immunizations to poor countries, was thinking about how the crisis would unfold if the virus swept across the globe. Hatchett, chief executive officer of the Coalition for Epidemic Preparedness Innovations, or CEPI, had just handed out research grants to three vaccine candidates. The two men were in Davos for the World Economic Forum, where public health organizations often go to drum up support and funding. Hatchett was concerned the world could see a repeat of the mistakes made during the H1N1 pandemic of 2009, when wealthy countries cornered the market for vaccines. (The fallout was limited; H1N1 turned out to be less deadly than feared.) He and Berkley agreed about the urgent need to raise money for vaccines even before they existed, so poor countries didn’t get left behind in a stampede for doses..A month later, Berkley flew to Seattle to meet with Bill Gates, who’d helped establish Gavi two decades earlier with his soon-to-be ex-wife, Melinda. Gavi was designed to fix what was perceived as a failure of the market: Pharmaceutical companies lacked a financial incentive to provide vaccines to poorer countries at affordable prices. Gavi attempts to counter that by pooling both demand and money, which puts it in a position to give manufacturers large, long-term contracts. Gavi has now helped vaccinate more than 800 million children against pneumonia, meningitis, and a range of other diseases, preventing an estimated 14 million deaths with routine immunizations. Over breakfast, Berkley and Gates discussed how the Gavi model might be used if scientists succeeded in the search for vaccines against the disease, by then called Covid-19..Over the next few months, Berkley and Hatchett, backed by Gates, the European Union, and others, developed the Covax Facility, a public-private partnership Gavi manages with CEPI and the World Health Organization. It’s now raised more than $10 billion as it aims to deliver 1.8 billion doses to more than 90 lower-income economies by early 2022..But Covax is struggling to get hold of vaccines, which means the world won’t return to normal anytime soon. So far, it’s been able to deliver about 78 million shots, or 4% of the 1.95 billion doses administered globally. At every turn, it’s been stymied by pharmaceutical companies drawing out negotiations and countries hoarding doses and raw materials. Most recently, Covax has been buffeted by an export ban imposed by the world’s biggest vaccine producer, India, which is experiencing a devastating second wave of Covid. As a result, it will reach the midpoint of the year about 190 million doses short of where it expected to be..In the U.S., about half the population has gotten one dose, while in low-income countries it’s 0.7%. Berkley acknowledges the inevitability of governments insisting on vaccinating their own populations first. But many nations are now in a position to share surplus doses—and they’re doing it at a pace he finds exasperating. “The goal should be to get to whatever level we need to end the acute phase of the pandemic,” he says. “Wealthy countries have ordered many times the amount of doses they need. It’s really time now to turn that around and either begin to make doses available through sharing or to free up places in the manufacturing queue to allow doses to go across the world.”.Some wealthy countries are beginning to kick doses Covax’s way. President Joe Biden announced in mid-May that by June, the U.S. would share 20 million doses from Johnson & Johnson, Moderna, and Pfizer, in addition to a stockpile of up to 60 million shots of the vaccine developed by AstraZeneca and the University of Oxford, which still hasn’t been authorized in the U.S. On June 3, the White House said it will send 25 million vaccines to countries around the world, including 19 million doses through Covax and another 6 million directly to countries including Mexico and South Korea, bypassing the global alliance because of “regional priorities.” The sharing of AstraZeneca doses remains on hold pending regulatory approval.Countries operating under the banner Team Europe have pledged to donate 100 million doses to low- and middle-income countries by the end of the year, mostly through Covax. On June 2, at a virtual summit hosted by Japan, the alliance raised almost $2.4 billion and secured pledges of another 54 million doses. All of that is welcome, but will barely make a dent in plugging the immediate supply gap..The U.S., now vaccinating children as young as 12, is in a position to immunize more than 300 million people by the end of June. Meanwhile, Covax is still scrounging. “That is very difficult to watch,” Hatchett says. At the current pace of immunization, it will take until the middle of next year to achieve a high level of global immunity and bring the pandemic under control..As cases in the U.S. and Europe decline and vaccines there become plentiful, Berkley says it’s dangerous to think anyone is safe. “If there are large populations with virus circulating, what’s going to happen is we’re going to have new variants,” he warns. “We’re going to have continued evolution of the virus, and that’s just going to come right back and threaten the U.S. as well as the rest of the world.”.At its most basic, Covax was set up to fend off what Berkley calls the threat of a “free-for-all, Lord of the Flies” situation. The idea was to provide free doses to low-income countries while at the same time allowing wealthy and middle-income countries to buy into a portfolio of vaccines as a way of spreading their bets in the early days when no one knew which shot might work. Covax’s large purchasing pool would secure deals with pharma companies at good prices. Developing countries would get vaccines at the same time as wealthier countries, with the doses distributed in proportion to population size. Health-care workers and the most vulnerable would go first. Only after 20% of populations were protected would the allocation formula start prioritizing countries based on a higher risk of Covid infections. If wealthier countries had relied primarily on Covax, instead of striking their own deals with pharma companies, they would have immunized younger people more slowly, so that vaccines could be distributed fairly, regardless of case rates..Berkley’s greatest fear was that rich governments would strike multiple bilateral deals with vaccine developers, sucking up supplies—and that’s exactly what they did. “On that we failed miserably,” he says. “There was a period of time when there weren’t as many bilaterals, but obviously there’s lots now.”.It might have been wishful thinking to bet that a newfangled “facility” could secure cut-price doses from pharma companies and large donations from strapped governments during the worst pandemic in a century. It’s probably fantasy to imagine the U.S. or Europe—two of the hottest hot spots during much of the crisis—handing over domestically produced doses early on and giving up the chance to lift lockdowns, get kids off remote learning, and revive moribund economies. But the decision cost lives elsewhere: Health-care workers and the elderly were left unprotected. Hatchett calls the situation an example of the “prisoner’s dilemma,” the game theory concept in which individuals, acting to protect their own interests, produce a worse outcome for everyone..The U.S. didn’t join Covax under Donald Trump. Instead, it launched Operation Warp Speed, which spent more than $12 billion to finance a portfolio of vaccine candidates. It was an enormous success; the funding helped scientists deliver shots faster than anyone expected. Berkley and Hatchett say Covax could have achieved something similar if it had had that kind of money early on—it could have, for example, done what a number of countries did and placed a large order in the fall with Pfizer, which produced the first vaccine to be U.S.- approved and didn’t take money from Operation Warp Speed for research and development. “Every political leader is trying to think about how they can deal with their own problems,” Berkley says. “We have to get everybody in the world to understand that if we’re going to deal with a global pandemic, we need a global solution.”.Most pharma companies didn’t prioritize Covax. In January, Pfizer Inc. agreed to sell it 40 million doses—at the time, less than 2% of its expected production in 2021. Most of those doses won’t arrive until the second half of the year. In early May, after months of negotiations, Moderna reached a deal to sell as many as 500 million doses to Covax, but they won’t start arriving until October or later and the vast majority will be delivered in 2022. The pricing on these deals is opaque, but cost obviously has been a problem for Covax. “We prefer not to put prices out, because it affects our negotiations with other companies,” Berkley says, adding that terms will be disclosed at a later date. Pfizer said in May that it expects about $26 billion in revenue from its Covid vaccine this year. Moderna has projected more than $19 billion in revenue from its shot. For now, Covax remains heavily dependent on AstraZeneca, which has pledged to sell its vaccine for no profit and struck an early deal with the alliance. The AstraZeneca vaccine accounts for about 95% of the doses the group has distributed..The U.S. said it would join Covax on the second day of the Biden presidency and now ranks as its single biggest donor. More than 190 governments are on board, including dozens of higher-income economies that signed up to use the alliance to buy doses. Arguably the most complex international peacetime operation ever attempted, Covax could serve as a template for responding to future pandemics. Berkley and his deputy at Gavi, Aurelia Nguyen, the managing director of Covax, are working with an alphabet soup of organizations to steer it. The WHO is advising where doses should go, helping countries get ready, and clearing vaccines for safety and efficacy. The United Nations Children’s Fund (Unicef) is helping with procurement, logistics, and storage. CEPI is backing research..India’s mismanagement of the pandemic is Covax’s biggest headache at the moment. With the help of the Serum Institute of India, the world’s largest vaccine manufacturer, the country was supposed to use its status as the “pharmacy of the world” to supply doses to poorer countries at low cost. Last year, the Bill & Melinda Gates Foundation, via Gavi, gave Serum $300 million to expand manufacturing capacity for Astra’s shot and another from Novavax Inc., which is likely to be approved in the coming months. Serum had planned to reserve half of its production for India and export millions of doses to Covax. In total it expected to produce 1 billion shots in 2021. It will likely fall short of its target..In January, while cases were low, Prime Minister Narendra Modi declared victory against the pandemic. That pronouncement contributed to a slow uptake of vaccines among Indians; only about 3% of the population is fully vaccinated. When the surge in infections started in the country in March, there was a spike in demand for doses, leading the government to all but stop Serum’s deliveries to other nations. CEO Adar Poonawalla said in mid-May that exports are unlikely to resume until the end of the year. Covax has been working with AstraZeneca to source doses from other suppliers and announced an agreement on May 21 to buy 200 million Johnson & Johnson doses, to be delivered by the end of the year. But the pitfalls of depending too much on production from a single country have been exposed dramatically..The shortfalls have created panic in many countries counting on Covax for their vaccination campaigns, along with resentment at wealthy nations that are swimming in vaccines. “We’re taking a tremendous amount of pressure and heat from countries that are understandably frustrated and angry about the inequity of distribution they see,” Hatchett says. In some cases, wealthy countries have a glut of vaccines because they used Covax as it was designed—they bought into the portfolio as an insurance policy. Many of them also kicked in cash to finance doses for poor nations. But they’re largely topping up their supplies—Canada, for example, is sitting on tens of thousands of Astra doses because of concerns it could cause rare blood clots. That doesn’t sit well where doses are scarce..On Feb. 24, the first shipment of Covax vaccines touched down in Accra, Ghana: 600,000 doses of the AstraZeneca vaccine produced by the Serum Institute, arriving from Mumbai via Dubai. It was more than two months after the first Covid vaccine was administered in the U.K..One hot day in mid-March, Anthony Annan, a 78-year-old retired civil servant, rode 5 kilometers in uncomfortable public vans to a vaccination site in the eastern part of the city in search of a vaccine. The frail man arrived exhausted. Supported by his tripod walking stick, he pulled out a white handkerchief to wipe the sweat from his forehead before approaching an official. “Hello, madam, can you help me get my Covid vaccination?” he asked in a shaky voice. The response was simple: “Sorry, sir, we have run out of vaccines.”.Two weeks later, Annan returned with his 69-year-old wife and 91-year-old mother-in-law, and all three got their first doses. “The fear of contracting this deadly disease has subsided,” he said after getting his shot, the relief in his voice palpable. “We will sleep a little better tonight.” With all the supply disruptions, however, he still hasn’t gotten his second dose..There’s a wrinkle in the story, one that speaks to Covax’s delicate balancing act: Ghana had, and still has, an exceedingly low prevalence of Covid. Should its doses have been sent to, say, Brazil, where the virus was surging? Or was it more important to protect health-care workers and the elderly in Ghana, in case it became the next Brazil, something that was possible though not certain? Covax takes the latter approach. The program’s critics say that’s both ethically and medically wrong. In a May 25 opinion piece in the New York Times, Ezekiel Emanuel and Govind Persad, a doctor and lawyer, respectively, wrote, “True, every country needs vaccines in the pandemic. But those needs are not equally urgent.”.Berkley says protecting health-care workers worldwide should be a top priority, and using vaccines to fight surging infections isn’t as straightforward as it looks. “We’ve learned from many other pandemics, if you say, ‘I’m going to go to the places that have the highest disease incidence,’ those may be countries on the top of the curve and on their way down,” he says. “The most efficient places you’d want to be is on their way up the curve, because that’s where you can get the maximum preventative effects of a vaccine.”.The fallout from India’s export ban is being felt acutely in countries that are suddenly facing spiraling infection rates. Nepal received 348,000 doses from Covax on March 7, the first of more than 1.9 million the alliance initially planned to deliver. It’s now grappling with a surge of cases spilling across its border with India, and no more Covax doses have arrived. “It was an incredible sign of hope, that this is the beginning of the end,” Elke Wisch, Unicef’s representative in Nepal, says of the first Covax delivery. “And now here we are just weeks later. The situation is definitely worse than it has been at any time so far in the pandemic.”.Covax is now negotiating with Chinese developers as it tries to make up for the loss of supplies from India. China has shipped more doses than all other countries combined, through deals with individual nations, typically places where it wants to secure more influence. Pivoting to provide doses to Covax—China is a member—would signal a shift. The WHO recently authorized vaccines by the Sinopharm Group Co. and Sinovac Biotech Ltd., opening the door for the companies to supply the global alliance..Critics say the world would be in a much better place if Covax had put pressure on pharmaceutical companies to waive patent protections and allow more manufacturers to produce vaccines by transferring their technology. In October, South Africa and India asked the World Trade Organization to allow a temporary waiver of intellectual-property protections on Covid vaccines. The proposal has gained support from more than 100 countries, and on May 5 the Biden administration announced it would support the waiver. That made a splash, but countries such as the U.K. and Germany remain opposed, making it hard to see how it will move ahead. The EU instead has said it might allow the use of compulsory licenses to make vaccines in times of crisis, but that remains a vague proposal at best..A coalition of nonprofits called the People’s Vaccine Alliance continues to push for patent waivers and to criticize Covax’s mainstream, working-within-the-system approach. “Covax is a welcome but inadequate charitable model,” says Anna Marriott, health policy manager for Oxfam International, a member of the alliance. “They were never challenging the system. They’re just a purchaser within the system. They managed to raise a tremendous amount of money, but they could have unlocked a bigger supply.”.Is that the case? The past year has made it painfully clear that Covax doesn’t even have the leverage to get the doses it needs, let alone to persuade companies to hand over formulas for making vaccines. As to equipping a fleet of new manufacturers, Berkley says there aren’t enough raw materials or people with the know-how to get new producers up to speed. Before the pandemic, the world had the capacity to make about 5 billion vaccines annually, including roughly 1.5 billion flu shots; manufacturers are trying to more than double that rate. If the sharing of technical knowledge is going to increase, governments will have to help. “We need to do everything we can to ensure that not only intellectual property but also knowledge is shared as widely as possible,” Berkley says. “We welcome any intervention that accelerates this process.”.Stéphane Bancel, CEO of Moderna, argues there will be too much vaccine production capacity by next year. Even if that’s true, more money is needed to inoculate the world. The returns are potentially enormous. The International Monetary Fund estimates that investing $50 billion in global vaccine delivery would generate an additional $9 trillion in economic growth by 2025. Some of that funding could help countries struggling with vaccination programs. According to a World Bank report in March, fewer than a third of the poorest nations had systems to train the large number of people needed to administer vaccines or public strategies to spur people to get them. That, combined with vaccine hesitancy, has meant that doses in some places are going bad..Covax couldn’t prevent the free-for-all Berkley worried about. There’s still a yawning gap between the haves and the have-nots. But the prospects of ending the crisis would look grim without it. “Tell me which other organization has tried to bite the bullet here,” says Klaus Stöhr, a virologist and former WHO official who played a key role in mounting the response to SARS in 2003. “Which other organization has been so ambitious that they are promising to do everything that it takes to give a vaccine to those who cannot afford it? There is no other one.”.Even countries that cut bilateral deals with pharma companies and paid only lip service to notions of vaccine equity are beginning to recognize that they need Covax to end the pandemic. Where pleas about equity didn’t work, appeals to self-interest are powerful. No one is safe until everyone is safe, as Berkley has been saying for more than a year..One clear need in the future, he argues, is a ready pool of funds to be rapidly deployed to invest in vaccines and therapeutics. Hatchett has outlined a $3.5 billion plan to fight future pandemics, including building a “library of vaccines” targeting different virus families using technologies advanced during the Covid race..An independent panel set up last year by the WHO to advise on preparing for future pandemics came up with similar conclusions in a report released in May. The panel proposed the creation of an International Pandemic Financing Facility to secure as much as $10 billion a year to bankroll preparedness measures, including vaccines. This facility would be overseen by a newly created Global Health Threats Council led by heads of state. The panel also recommended “shifting from a model where innovation is left to the market to a model aimed at delivering global public goods,” by requiring companies to share technology and provide licenses to manufacturers when government funds are invested in research..The Covid vaccines are a triumph, but banking on more triumphs as a bulwark against future pandemics would be madness. That, say Berkley and Hatchett, is why it’s crucial to put an equitable financing model in place. “We’re lucky, because the vaccines have been successful,” Berkley says. “But we could be in a situation with a much more difficult pathogen. We might have to try many different products, and many of them might fail. That would be an even bigger challenge.” —With Ekow Dontoh and Josh Wingrove.©2021 Bloomberg L.P.

The World’s Best Hope to End the Pandemic Still Needs More Doses

Nonprofit Covax has been saying for a year no one is safe until everyone is. Rich countries may finally be getting the message.

Choose a plan