Very important story for today on Bill Gates, the management of COVID vaccines and the WHO, published Nov 23, 2020 in NYT. But I could only find the full article in the Seattle Times.

I have added comments and bolded what I think is most relevant

By NICHOLAS KULISH and Megan Twohey

https://www.seattletimes.com/nation-world/bill-gates-the-virus-and-the-quest-to-vaccinate-the-world/

The head of one of the world’s largest vaccine manufacturers had a problem. Adar Poonawalla, chief executive of the Serum Institute of India, needed $850 million for everything from glass vials to stainless steel vats so he could begin producing doses of promising coronavirus vaccines for the world’s poor.

Poonawalla calculated that he could risk $300 million of his company’s money but would still be more than $500 million short. So he looked to a retired software executive in Seattle.

Bill Gates, the Microsoft founder turned philanthropist, had known Poonawalla for years. Gates had spent billions to help bring vaccines to the developing world, working closely with pharmaceutical executives to transform the market. In doing so, he became the most powerful — and provocative — private player in global health.

By the end of their conversation this summer, Gates had made a promise: The Bill and Melinda Gates Foundation would provide a $150 million guarantee so the Indian factory could move ahead with production. By September, the foundation had doubled its commitment.

It is part of an $11 billion effort to lay the groundwork to procure coronavirus vaccines for more than 150 countries, though it could eventually cost far more when the doses come through. Funded largely with public [taxpayer—Nass] money, the initiative is led by two global nonprofits that Gates helped launch and bankroll, along with the World Health Organization, which relies on the Gates Foundation as one of its largest donors.

Working behind the scenes is the world’s second-richest man, neither a scientist nor a doctor, who sees himself and his $50 billion foundation as uniquely prepared to take a central part. Gates and his team are drawing on connections and infrastructure the foundation has built over two decades to help guide the effort.

“We know how to work with governments. We know how to work with pharma. We’ve thought about this scenario,” Gates said in a recent interview. “We need — at least in terms of expertise and relationships — to play a very, very key role here.”

As the first vaccine candidates sprint toward regulatory approval, the question of how to immunize much of the world population has taken on added urgency. But nine months in, the success of the vaccine effort, known as Covax, is not at all certain. [Covax has basically failed and folded—Nass]

So far, it has pulled in only $3.6 billion in funding for research, manufacturing and subsidies for poor countries. Three companies have promised to deliver vaccines, but it is not yet known whether they will be effective. And it may be difficult to secure the necessary billions of doses in an affordable, timely way because the United States and other wealthy countries have cut separate deals for their citizens.

In recent months, Gates, who emphasizes that he is one of many involved in the vaccine effort, has hosted online roundtables with drug company officials. He has pursued financial commitments from world leaders; in one week alone, he and his wife and co-chair, Melinda Gates, spoke with President Emmanuel Macron of France, Chancellor Angela Merkel of Germany, President Ursula von der Leyen of the European Commission and Crown Prince Mohammed bin Zayed of Abu Dhabi, United Arab Emirates.

In Washington, Bill Gates has consulted frequently with Dr. Anthony Fauci, the nation’s chief infectious disease expert and a longtime collaborator on vaccine initiatives, and talked to Sen. Mitch McConnell, a polio survivor who has been supportive of programs to eradicate that and other scourges. And to help staff the vaccine effort, his foundation has provided millions of dollars for McKinsey & Co. consultants.

“Some people will say, ‘Why should it be him?’” said Dr. Ariel Pablos-Méndez, former director of knowledge management at the WHO. “He has the star power. He has the resources. He cares. There are many players that do things, but not at the scale of Gates.”

If the initiative, aided by Gates’ fortune and focus, manages to help protect the world’s poor from a virus that has already killed more than 1.3 million people, it will affirm the strategies he has promoted in his philanthropic work, including incentives for drug companies.

If the endeavor falls short, however, it could intensify calls for a more radical approach.

Amid the pandemic, some public health officials and advocates argue that vaccine-makers, many of which have benefited from unprecedented public funding, should be compelled to share their technology, data and know-how to maximize production. India and South Africa, for example, are pushing to suspend the global enforcement of intellectual property rights involving the virus. [Gates has worked to stop this—Nass]

Dr. Zweli Lawrence Mkhize, South Africa’s health minister, said that the usual practices did not apply in this crisis. “There has to be a degree of broader consultation that looks at what is best for humanity,” he said in an interview.

In the current plan for a global vaccine deal, poor countries would receive only enough doses to inoculate 20% of their populations by the end of next year. Some models show that there will not be enough vaccines to cover the entire world until 2024.

“The consequence of longtime Gates strategies is that they go along with corporate control over supply,” said Brook Baker, a Northeastern University law professor and policy analyst for Health GAP, which advocates equitable access to drugs. “In a pandemic, that is a real problem.”

Meanwhile, officials from some countries participating in the vaccine initiative complain that they were barely consulted until recently. “They are pushing us, cornering us, in order to make us pay,” Juan Carlos Zevallos, Ecuador’s health minister, said of the deal-makers. “We don’t have a choice about which vaccine we would like to use. It is whatever they impose on us.”

As Gates has made public appearances to win support for the initiative, he has increasingly become the target of conspiracy theories that could undermine vaccination efforts.

Some falsely claim that his foundation tested vaccines that killed thousands of children in Africa and India, while others link him to bogus depopulation efforts. One poll from May found 44% of Republicans believed that the global immunization effort was a cover for Gates to implant microchips to track people. That claim is baseless.

Gates remains undaunted.

“I’ve never heard either Bill or Melinda say anything to the effect of, ‘We’ll just work on something else; this is too tough,’” said billionaire investor Warren Buffett, who entrusted the Gates Foundation with $31 billion of his own fortune to give away. “The job is to work on tough problems.”

‘The Bill chill’

As a novel coronavirus linked to a live animal market began spreading rapidly in Wuhan, China, Gates watched from his office outside Seattle.

On Feb. 14, he and leaders at his foundation, fearing a global threat, gathered to plan a response. From that point on, Gates recalled, “we’re on Code Red.”

Two weeks later, Dr. Seth Berkley — chief executive of Gavi, the Vaccine Alliance, a nonprofit the Gates philanthropy helped found — flew to Seattle. Over breakfast, he and Gates considered how to get COVID-19 vaccines to the developing world. On March 13, two days after the WHO declared a global pandemic, Gates conferred online with 12 top pharmaceutical executives, including the heads of Pfizer and Johnson & Johnson, which both have leading vaccine candidates.

He felt prepared for this moment, having built up global institutions and given away $55 billion to date, four times the influential Ford Foundation’s endowment.

Gates became interested in immunizations in the late 1990s, when Microsoft was facing an antitrust case that cast him as a modern-day robber baron. [Many wonder if the DOJ gave Gates a deal to manage a vaccine program privately for the USG or its puppet masters.—Nass] Vaccines involved creating new technology, his specialty. Their effect was measurable; inexpensive doses could protect hundreds of millions against devastating disease. They were also about making deals.

Many Western drug companies had stopped producing vaccines back then, finding them unprofitable. But through his giving, Gates helped create a new business model involving subsidies, advance market commitments and volume guarantees. [Advance market commitments is a euphemism for inveigling countries in sleeper contracts in which they promise in advance to pay for future, unknown vaccines that might someday be used—usually when the Director-General of the WHO makes a declaration of a pandemic—without knowing whether they are safe or effective, and promising to waive liability—Nass] The incentives drew in more manufacturers [of course—Nass], including ones from the developing world, resulting in many more lifesaving vaccinations.

He brought a “technocratic expertise and power rather than a discourse of human rights and activism,” said Manjari Mahajan, an associate professor of international affairs at the New School who has written about Gates’ role in public health.

His foundation has spent more than $16 billion on vaccine programs, one-quarter of that going to Gavi, and given $2.25 billion to the Global Fund to Fight AIDS, Tuberculosis and Malaria. Both organizations are based in Geneva, where the WHO has its headquarters.

With a $100 million initial pledge, Gates helped create the Coalition for Epidemic Preparedness Innovations, in Oslo, Norway, to invest in drugs and experimental vaccines. (The coalition [which pioneered the impossible 100 day plan for vaccine development without any liability, led by Jeremy Farrar, now the WHO’s Chief Scientist—Nass] and Gavi are leading the coronavirus vaccine effort with the WHO.)

The foundation, which has about 1,600 employees, also funded academic researchers, installed its executives on the boards of multiple nonprofits and directly invested in drug companies.

One of them was the German company BioNTech, which got a $55 million equity investment in September 2019. [Before anyone but Bill Gates seemed to know a pandemic was coming.—Nass] The business, partnering with Pfizer, announced last week that their jointly developed COVID-19 vaccine appeared to be 95% effective, and applied to the Food and Drug Administration for emergency authorization.

Some public health officials disagreed with Gates’ priorities, arguing that he should have directed more money to health systems. Others worried about a private individual wielding so much influence. But few people publicly criticized his foundation, fearful of losing its support. That self-censorship was so widespread it acquired a nickname: “the Bill Chill.”

At times, frictions were evident with the WHO, the United Nations agency charged with international public health. Gates felt frustrated with what he viewed as the organization’s rigid bureaucracy and constraints on dealing with the private sector.

Some at the WHO had concerns about his growing reach. The malaria division chief complained in a 2007 memo that the foundation’s growing dominance of malaria research was stifling a diversity of viewpoints among scientists and undercutting the agency. The same year, the foundation began building up an institute that rivaled the WHO’s role in health metrics.

“The Gates Foundation presence has been, at best, an adjunct to WHO and at worst a hostile takeover and a usurpation,” said Amir Attaran, a University of Ottawa professor of law and medicine.

Today, the foundation and the WHO stress their mutual respect for each other. Publicly, Gates has made a point of praising the agency. “I can’t think of anything that we disagree with them” on, he said in the interview.

Officials from the agency — which receives hundreds of millions of dollars annually from the foundation, its second-largest donor — said Gates had helped it become more efficient. “Gates pushes the science, pushes for the answers, because that’s a little bit of that private-sector mentality,” said Dr. Bruce Aylward, senior adviser to the WHO’s director general.

As the coronavirus vaccine effort got underway, it was folded into a broader mission, coordinated by the WHO, to also provide COVID-19 diagnostic tests and therapies to the developing world. The agency wanted to take more of a leadership role in the vaccine deal-making, but the Gates Foundation and global nonprofits said they worried that drugmakers would not cooperate. They worked to focus the agency’s role on regulating products and advising countries on distributing them, among other responsibilities.

“We’re always talking with WHO,” Gates said. “But a lot of the work here to stop this epidemic has to do with innovation in diagnostics, therapeutics and vaccines, which isn’t really their bailiwick.” [Yet now the WHO suddenly wants to take over management of vaccines and therapeutics for future public health emergencies, suddenly gaining such expertise as if by magic.—Nass]

Farah Dakhlallah, a WHO spokesperson, said that the organization had an “unmatched” ability to coordinate a global health response and that the initiative leveraged “the comparative advantages” of its partners in the fight against COVID-19.

Capitalism at work

In March, Gates was urging drugmakers to move fast, cooperate with one another, open up their libraries of drug compounds and even share production responsibilities.

“The first set of meetings, it was, ‘How are we going to find an active drug? How are we going to kick off vaccine development quickly? How are we going to shift manufacturing capacity?’” recalled Vasant Narasimhan, chief executive of Novartis.

The Gates Foundation employs former pharmaceutical executives in its top ranks, including Dr. Trevor Mundel, who had been global head of development at Novartis, and Emilio Emini, previously a senior vice president of vaccine research at Pfizer. Working with the Coalition for Epidemic Preparedness Innovations, they helped steer money into COVID-19 vaccine candidates and biotechnologies that could be quickly manufactured and suitable for the developing world. [Not good enough for the developed world, and most likely untested, but good enough for the developing world—Nass]

Oxford University said it would offer “nonexclusive, royalty-free licenses” of its work to manufacturers. But as it developed one of the most promising vaccine candidates, the university debated whether it was equipped to conduct clinical trials and transfer its technology to manufacturers around the world.

Sir John Bell, who leads the development of Oxford’s health research strategies and chairs the Gates Foundation’s scientific advisory committee, reached out to Mundel. The advice was direct: “We told Oxford, ‘Hey, you’ve got to find a partner who knows how to run trials,’” Gates said.

Oxford chose British Swedish drugmaker AstraZeneca. The Serum Institute of India, after getting the financial commitment from Gates, agreed in the summer to start producing the vaccine.

All the while, the United States and other countries were striking their own deals with vaccine-makers, even before they got regulatory approval. There was some overlap between the global initiative and the U.S. effort, called Operation Warp Speed. AstraZeneca, Novavax and Sanofi made commitments to both.

Gates was quick to praise the U.S. government’s enormous investment in expediting coronavirus vaccines, saying it would benefit everyone. But the more that countries locked down bilateral deals, the longer the rest of the world would have to wait for doses.

Gates had valuable insights from Fauci, who leads the National Institute of Allergy and Infectious Diseases. More than a decade ago, the billionaire had invited Fauci to his home to join a discussion about tuberculosis. Since then, they have coordinated efforts aimed at fighting not just that disease but also malaria, polio and AIDS.

The two men spoke every few weeks. Fauci wanted to know how vaccine trials in foreign countries were playing out. Gates was interested in how the U.S. regulatory process was going and whether vaccines the U.S. government was purchasing would be suited for poor countries. The Pfizer and BioNTech vaccine, for instance, requires two doses and ultracold storage, obstacles in many places. [Soon this requirement evaporated. What happened? Was it an excuse to direct vaccines to those places that could provide the ultracold freezers—and stiff those that could not? Who knows?—Nass]

“He wanted to make sure, which is the classic Bill Gates, that as we do the vaccines, that it’s the kind of vaccine that could be used in the developing world,” Fauci said in an interview.

During the pandemic, Latin America has suffered one-third of the world’s deaths. Africa has now passed 2 million cases. Quarantines and trade shutdowns have hit poor countries especially hard, where not working often means not eating.

Some public health advocates and on-the-ground providers like Doctors Without Borders thought Gates was doing too little to pursue equitable access to vaccines and was too aligned with the pharmaceutical industry.

“Part of what they like about him is, he’s protecting their way of life,” James Love, director of Knowledge Ecology International, a nonprofit that works to expand access to medical technology, said of Gates and drug industry executives. “Because this message is always, ‘Big Pharma is awesome.’”

He and others believed that vaccine-makers would not maximize production for the developing world, especially when rich countries were clamoring for doses, because it wouldn’t serve their bottom line. India and South Africa, in asking the World Trade Organization not to enforce coronavirus-related intellectual property rights, were seeking a way to wrest control of vaccines from big companies and ramp up local manufacturing. Kenya, Mozambique, Pakistan and Eswatini (formerly Swaziland) recently signed on as co-sponsors to the request, with dozens of other countries expressing support.

But Gates and many public health experts thought that most companies were taking laudable steps to help ensure access, such as nonprofit pricing and licensing of their technology to other manufacturers. They argued that drugmakers wouldn’t take on the costly process of creating new products if their lucrative patents were jeopardized and that their control over their vaccines would ensure quality and safety.

“This capitalism thing — there actually are some domains that actually works in,” Gates said. “North Korea doesn’t have that many vaccines, as far as we can tell.”

‘Acting like a lobbyist’

It was May 4, and the Gateses were on a video call with Boris Johnson. They congratulated the British prime minister on the birth of his son and asked about the COVID-19 case that had sent him to the hospital.

Then they made their pitch: The world would never be safe from the virus and the global economy would never recover unless poor countries received vaccines and treatments too.

Bill Gates had a long record of getting rich countries to provide funding for public health initiatives in poorer countries. From Merkel to McConnell, politicians saw him as a steward of public dollars with a nose for good investments.

“He has immediate access to us because of his fame and reputation and what he’s doing with his own money,” McConnell, the Senate majority leader, said in an interview. “In many of these countries, he’s way more effective than the government is, and that’s certainly value added for public health all over the world.”

Significant donations came from Britain, the European Union and elsewhere. China pledged its cooperation last month. But Gates made no headway with his home country.

He had asked the Trump administration and Congress for $8 billion, half for the global vaccine effort and half for therapeutics and diagnostics in poor countries. In private calls, Gates, who had forged ties with leaders of both parties but remained nonpartisan over the years, made his case to Vice President Mike Pence, House Speaker Nancy Pelosi and others.

He put himself in the public eye more than ever before, often appearing in a pastel sweater that drew comparisons to Mister Rogers and repeating in interviews that the pandemic required an international response. “He’s made a choice to become very public, very political, where he’s acting like a lobbyist,” said Lawrence Gostin, professor of global health law at Georgetown.

But President Donald Trump had no intention of joining a global response. That became clear in July, when he withdrew the United States from the WHO, which it had provided with more than $400 million in annual contributions. [Trump later gave half a billion dollars to Gates’ GAVI.—Nass]

“People aren’t used to not having the U.S. step forward,” Gates said. On the global vaccine effort, he acknowledged, the nation has been “a no-show.” President-elect Joe Biden may well take a different position, having vowed to rejoin the WHO.

Leaders of wealthy countries were asked not only to help fund the initiative — which was supporting development of nine potential vaccines — but also to buy doses for their own populations. Among the nine was a version from Moderna, which recently announced impressive clinical trial results. As the deal-makers framed it, even nations that already had commitments from vaccine-makers would benefit by diversifying.

Companies either would charge all countries the same price or set tiered prices for low-, middle- and high-income nations; any could bow out if the price exceeded $21 per dose. [So that is why the initial price was $20/dose—Nass] Poor countries could get cheap, subsidized doses for up to 20% of their populations by the end of next year, but the wealthier nations could sign up for more.

Clemens Martin Auer, a chief negotiator for the European Union, balked, believing that the global vaccine deal was moving too slowly, that prices would be too high and that Europe could do better negotiating on its own.

“I think the Gates Foundation has in many respects a very practical approach when they say this has to be done in a private-public business partnership,” he said. “But I sometimes have my impression that the Gates Foundation doesn’t understand how well-organized governments work.”

With so much attention on wealthy nations, there was little consultation with those the effort was intended to help most. It wasn’t until the fall that lower-income countries learned they would have to pay $1.60 or $2 per dose, a significant price that would require some to secure bank loans or grants.

“It’s going to be subsidized, yes, but countries still have to budget for their copay amount,” said Chizoba Barbara Wonodi, the Nigeria director at the Johns Hopkins International Vaccine Access Center. “So they need to be at the table when those discussions are made.”

Some middle-income countries have also felt squeezed, asked to pay prices in a higher tier, with little say as to what they would get or when they would get it.

Zevallos, the Ecuadorian health minister, said he had spoken with fellow ministers in the region about raising concerns through their presidents. “They say, ‘You don’t get to choose, but you pay,’” Zevallos said. “I’m disappointed.”

Berkley, the Gavi director, acknowledged the frustration. “Did we communicate with everybody as well as we should? Absolutely not,” he said. “Were we able to convene everybody as often as we could? Absolutely not. But we did our best to try to do that.”

At the same time, Berkley said, “have we brought together the entire world to discuss equitable access to vaccines? Have we raised substantial amounts of funds? All of that is true.”

A growing number of countries have committed to the endeavor, the three drugmakers that have signed on are advancing through trials, and the Gates Foundation is also funding a portfolio of second-wave vaccines targeted at the developing world. There is enough money to start buying doses once they are approved, Berkley and others said, and they hope to pull together the billions more needed to meet their goals.

With coronavirus cases multiplying worldwide, Gates said there would be one simple way to judge the global vaccine initiative: “When did we stop the pandemic? That’s the thing this all needs to be measured by.”