SEATTLE — As a dangerous new virus began spreading around the globe in early 2020, the Bill & Melinda Gates Foundation turned to a tried-and-true playbook.
It’s an approach that has worked well for the Seattle philanthropic giant for more than two decades, ever since it set out to boost childhood vaccinations in the developing world. Back then, the foundation helped bankroll a new, global entity — Gavi, The Vaccine Alliance — to broker deals with pharmaceutical companies, pool donations from wealthy countries and provide low-cost shots for the world’s poorest kids.
Faced with the first pandemic of the modern era, the foundation and its partners relied on the same blueprint to create an entity called COVAX that would operate in a similar way to ensure access to COVID-19 vaccines in low- and middle-income countries.
But as of mid-June, COVAX has shipped fewer than 90 million doses to countries with a collective population of about 6 billion. It’s unlikely the initiative will meet even its original, modest goal of providing 2 billion doses by the end of this year — enough to fully vaccinate just 20% of those people.
Recent pledges from the U.S. and other wealthy nations to chip in a billion doses over the next two years will help, but global coverage probably won’t be achieved until 2023, the Gates Foundation’s global health chief acknowledged.
“It is a crisis the likes of which I don’t think any of us have ever seen in our lives or anticipated,” said Dr. Trevor Mundel.
Now, the Gates Foundation itself is coming in for an unprecedented level of criticism from activists who say the powerful philanthropy helped create the crisis.
By staunchly supporting the patent rights of vaccine developers, Bill Gates and his team prevented more widespread production and hindered global access to the lifesaving shots, journalist Alexander Zaitchik argued in a recent article in the left-leaning New Republic. Headlined “Bill Gates, Vaccine Monster,” the story features an illustration of the Microsoft co-founder surrounded by flames and sporting horns — a far cry from the geeky, but benevolent, persona Gates usually projects.
Other critics give the foundation credit for devoting $1.8 billion to pandemic response and for its early investments in messenger RNA vaccines and other technologies that have proved instrumental in fighting the novel coronavirus. But as the most powerful private player in global health, Gates and the foundation share in the responsibility for COVAX’s shortcomings and the huge gap between vaccination rates in rich and poor countries, they say.
“The Gates Foundation’s footprint has been all over the COVID response with respect to access in low- and middle-income countries,” said Northeastern University law professor Brook Baker, a policy analyst for the nonprofit Health GAP, which advocates for equitable access to medicines. “And what we’ve seen, because of the intellectual property controls Bill Gates and the Gates Foundation have supported … is artificially restricted capacity and supplies, needlessly high prices and grotesquely inequitable distribution.”
The outspoken critiques are unusual. Almost every organization in global development and health receives — or hopes for — funding from the Gates Foundation. Few dare voice concerns about its approach.
(The Gates Foundation contributes to The Seattle Times’ Education Lab, a reporting project that spotlights approaches to persistent problems in public education.)
The foundation’s leading role in the pandemic response has subjected it to greater scrutiny than ever before. Bill and Melinda Gates’ impending divorce, along with revelations about Bill Gates’ infidelity and allegations of a toxic culture at the firm that manages his $130 billion fortune, have also undermined the foundation’s carefully curated image and weakened its moral credibility, said Lawrence Gostin, an expert in public health law at Georgetown University Law.
“Overall, I think the Gates Foundation has recently taken a significant reputational hit,” Gostin wrote in an email. But he still believes the foundation has been a positive force in the pandemic and in their broader mission to improve health and well-being around the world.
“Even with these setbacks, their contribution to the global public good cannot be overstated,” he wrote.
Poor countries left behind
Established in April 2020, COVAX was a good idea, said Dr. Joia Mukherjee, chief medical officer for Partners In Health, a global nonprofit focused on reducing health disparities. “The fact that there was at least a plan for technology sharing even before the vaccines were created was a huge, positive step forward.”
But Mukherjee says reliance on a market-based approach was problematic.
Patents give companies total control over their formulas and where, how and at what prices products are produced — which pharma insists is vital to ensure profits and encourage development of new drugs. Participation in COVAX is voluntary. Companies set the terms, and details about the deals are kept secret.
That put low-income nations at a disadvantage in the heated rush for COVID-19 vaccines. Citing the global emergency, in December India and South Africa called for patents to be suspended (or “waived”) to increase production and reduce prices by forcing companies to share their technology.
“The market model, when it comes to medical care, drugs and vaccines, will always fail the poor,” Mukherjee said.
Indeed, rich countries quickly snapped up the COVID-19 vaccine supply, pricing out COVAX. The Trump administration refused to provide funding, and donations from other nations were slow to trickle in. COVAX was initially able to broker only a few deals.
The coalition’s first focus was the Oxford-AstraZeneca vaccine, which doesn’t require extreme low temperatures. The Gates Foundation put up $300 million to jump-start production at the Serum Institute of India — the world’s largest vaccine manufacturer — with the goal of producing 200 million shots.
Unfortunately, the vaccine proved less effective against some new variants of the virus. Then the entire enterprise was derailed this spring when India was slammed with a deadly surge of novel coronavirus and imposed an indefinite halt on all COVID-19 vaccine exports.
With COVAX forced to delay shipments and vaccination rates in poor countries averaging under 1%, the Biden administration did an about-face in early May and announced support for patent waivers. The Gates Foundation followed suit the next day — even though Bill Gates told an interviewer just a week earlier he didn’t think waivers would be helpful.
The Gates Foundation is just one player in a complex, international web of intellectual patent law — but it wields enormous influence. Had Gates supported the idea earlier, the situation in the developing world might not be as dire today, activists argue.
If companies knew they would be required to share their “secret recipes,” many might have entered voluntary agreements that opened up additional production, Mukherjee said.
“What we need is essentially generic manufacturing of these vaccines.”
But neither the Gates Foundation nor any major companies supported a voluntary, technology-sharing pool established by the World Health Organization. And when scientists at Oxford University announced plans to offer nonexclusive, royalty-free licenses to the vaccine they developed, Gates officials urged them to partner exclusively with a pharma company experienced in conducting clinical trials so effectiveness could be determined quickly. Oxford chose AstraZeneca.
Critics say the foundation’s intervention sent a clear signal to other vaccine developers who might have been willing to make their technology more widely available.
“We’re fine with companies getting money when they license their technology. The problem we have is with exclusivity,” said James Love, founder and director of Knowledge Ecology International, which focuses on intellectual property and access to drugs. “If Oxford had gone nonexclusive, it would have been easier for others to do that, too.”
Instead, COVAX was presented as the primary avenue to get vaccines to low- and middle-income countries. “It was set up as a promise to deliver, and it hasn’t,” Baker said. “What we have now is vaccine apartheid.”
“It’s about political will and money.”
A software billionaire whose fortune was rooted in intellectual property, Bill Gates is a firm believer that patent protections ensure innovation. Foundation officials point to the success of Gavi, which is based on voluntary licensing, in expanding childhood vaccinations and saving millions of lives.
The main factor limiting production of COVID-19 vaccines is not patents, but a shortage of facilities and people with the necessary expertise, said Violaine Mitchell, a foundation staffer who works with Gavi and COVAX. In addition to sharing their “recipes,” companies would need to share technology and know-how. Many key materials are also in short supply.
“I think there’s an assumption that we waive the (intellectual property) and suddenly vaccines are going to start flowing,” Mitchell said. “But it’s not as if we currently have a lot of vaccine manufacturing facilities sitting in mothballs.”
Pharma companies made similar arguments in the 1990s, when they were fighting to maintain patents on AIDS drugs that were out of reach for people in the developing world, Mukherjee pointed out. Today there’s a thriving generic industry because waivers forced the companies to share.
Vaccines are more complicated to make, but that’s more reason to get started as soon as possible, she said.
“It’s about political will and money.”
Even though most COVID-19 vaccines were backed by massive public investments, the profits have enriched a handful of companies and individuals, said Asia Russell, executive director of Health Gap. Yet Uganda, where she lives, had received just 100,000 doses by early June for a population of more than 47 million people.
“What we hope is that the waiver, along with the shift of power that comes with it, will result in more companies coming to the table with more supply,” Russell said.
The next challenge
Waivers are not a done deal, though. They must be negotiated through the World Trade Organization and many European nations remain opposed. Even if granted, all the waivers will do is allow individual countries to compel vaccine makers to license their technology to other companies for a fee.
The Gates Foundation and its critics agree on the need for additional vaccine manufacturing plants in the developing world, particularly Africa. Mundel said the foundation is exploring whether it might be possible to modify a plant in Senegal that produces yellow fever vaccine and expand the capacity of a South African facility under contract to perform the final step in production of the Johnson & Johnson vaccine — filling vials and packaging.
Foundation staff are also beginning to work with nations on regulatory and monitoring systems to ensure high-quality vaccines.
That additional capacity may not be available quickly, but could be in place before the next pandemic, activists say.
More short-term relief will arrive as the major vaccine companies reach their peak production levels, which Mundel estimates will occur by the second quarter of 2022. Most of those companies — including Moderna and Pfizer — now have contracts to provide doses to COVAX. The Novavax vaccine, which recently reported stellar results, could also be in production soon.
“At that stage, there will be literally billions of doses available,” Mundel said.
Donated shots from wealthy countries with vaccine to spare are also likely to increase. The 500 million doses pledged by President Biden will be purchased at cost from Pfizer and mostly distributed through COVAX.
The next challenge will be delivering those shots to people in nations that may have never mounted large-scale vaccination campaigns for adults.
“Buying the vaccine is just the first step,” Mitchell said. “Getting it in people’s arms is the really hard part.”
Now that the initial vaccination frenzy in the Western world is abating, the plight of people elsewhere is getting more attention from wealthy countries, which have stepped up financial commitments to COVAX. Not least among their worries is a selfish one: As long as the virus flourishes in any part of the globe, it creates opportunities for nastier new variants to evolve.
While COVAX has fallen short of expectations, Mitchell said she’s convinced the situation would be far worse without it.
“Are any of us pleased with how we’re doing? No,” she said. “Part of me thinks in global health we should hang our heads in shame.”
Advocates hope the Gates Foundation’s belated concession on patent waivers might signal a shift in philosophy.
Mundel, a former pharma executive, makes that sound like a longshot.
“By and large we do remain convinced that (intellectual property protection) has been a major source of innovations in public health, as well as in terms of getting people to invest at-risk,” he said. “So I don’t think that position has changed at all.”
