Jay Hancock, Kaiser Health News August 25, 2020
In a business driven by profit, vaccines have a problem. They’re not very profitable — at least not without government subsidies. Pharma companies favor expensive medicines that must be taken repeatedly and generate revenue for years or decades. Vaccines are often given only once or twice. In many parts of the world, established vaccines cost a few dollars per dose or less.
Last year only four companies were making vaccines for the U.S. market, down from more than 20 in the 1970s. As recently as Feb. 11, Dr. Anthony Fauci, the government’s top infectious disease expert, complained that no major drug company had committed to “step up” to make a coronavirus vaccine, calling the situation “very difficult and frustrating.”
Oxford University surprised and pleased advocates of overhauling the vaccine business in April by promising to donate the rights to its promising coronavirus vaccine to any drugmaker.
The idea was to provide medicines preventing or treating COVID-19 at a low cost or free of charge, the British university said. That made sense to people seeking change. The coronavirus was raging. Many agreed that traditional vaccine development, characterized by long lead times, manufacturing monopolies and weak investment, was broken.
“We actually thought they were going to do that,” James Love, director of Knowledge Ecology International, a nonprofit that works to expand access to medical technology, said of Oxford’s pledge. “Why wouldn’t people agree to let everyone have access to the best vaccines possible?”
A few weeks later, Oxford—urged on by the Bill & Melinda Gates Foundation—reversed course. It signed an exclusive vaccine deal with AstraZeneca that gave the pharmaceutical giant sole rights and no guarantee of low prices—with the less-publicized potential for Oxford to eventually make millions from the deal and win plenty of prestige.
Other companies working on coronavirus vaccines have followed the same line, collecting billions in government grants, hoarding patents, revealing as little as possible about their deals—and planning to charge up to $37 a dose for potentially hundreds of millions of shots.
Even as governments shower money on an industry that has not made vaccines a priority in the past, critics say, failure to alter the basic model means drug industry executives and their shareholders will get rich with no assurance that future vaccines will be inexpensively available to all.
“If there were ever an opportunity” to change the economics of vaccine development, “this would have been it,” said Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School who studies drug-pricing regulation. Instead, “it is business as usual, where the manufacturers are getting exclusive rights and we are hoping on the basis of public sentiment that they will price their products responsibly.”
In the United States and other developed nations, the solution to drug-company reluctance was to shower them with billions of dollars in public funds to persuade them to help. The Trump administration has announced deals worth more than $10 billion with seven companies to try to turn basic research—often funded by the government—into effective, widely distributed vaccines—but with no guarantee they would be widely affordable or available.
That approach has driven up stock prices in the past four months and enriched drug executives betting with somebody else’s money.
AstraZeneca stock and options owned by CEO Pascal Soriot have increased by nearly $15 million in value since early April, according to calculations by KHN based on company disclosures. The stock hit an all-time high in July. The stock market value of Novavax, a biotech that never recorded a profit in more than two decades, soared tenfold to $10 billion after a nonprofit and the Trump administration agreed to give it $1.6 billion to make a vaccine.
Companies “say we have to charge high prices because we are taking a risk,” said Mohga Kamal-Yanni, an independent consultant on global health based in the United Kingdom. “Actually, the public is taking the risk. The public is paying for the cost of research and development and probably the cost of manufacturing as well.”
Moderna, another company working on a vaccine candidate, received nearly $1 billion from the U.S. government to pay essentially all costs to research the product and get it approved by regulators. It’s using a vaccine designed in large part by the National Institutes of Health and academic scientists using federal grants.
If the vaccine works, the company gets an additional $1.5 billion to cover 100 million doses, a deal that U.S. Rep. Lloyd Doggett, a Texas Democrat, likened to giving taxpayers “the privilege of purchasing that same vaccine that we already paid for.”
That deal comes to $15 a dose. Moderna told Wall Street analysts it might charge as much as $37 a dose for smaller-volume contracts.
“This is greedy, and the taxpayers who have funded all of this should have expected better negotiation on the part of the U.S. government,” said Margaret Liu, a globally respected vaccine scientist who once worked for Merck and is now chairperson of the International Society for Vaccines.
The U.S. Health and Human Services Department “conducted extensive market research and price analysis” to ensure prices are fair, said a senior HHS official who asked for anonymity. “We are prohibited from disclosing price discussions and details.”
Even if Moderna distributed a successful vaccine at a loss to make it widely available, it would reap enormous benefits because government support would have helped validate its technology for future products, Liu said. Moderna did not respond to requests for comment.
Nonprofits such as Oxfam and Doctors Without Borders have been pressuring drug companies to change for years. Exclusive patents and high prices that sometimes make lifesaving medicines unaffordable in rich countries often render them completely unavailable in the poor world, they argue.
One workaround has been enormous private and government subsidies, including from the U.K., the United States and the Gates Foundation, to promote developing-nation vaccines through the Geneva nonprofit Gavi, formerly known as the Global Alliance for Vaccines and Immunization.
The Gates Foundation helped launch another non-governmental organization, the Coalition for Epidemic Preparedness Innovations, in 2017. CEPI was created to fight something exactly like the coronavirus: potential infectious threats ignored or slighted by pharmaceutical companies.
CEPI’s early principles of “equitable access” drew praise from reformers. The group asked for public data disclosure from drug-company grantees, “transparent” accounting to show true vaccine cost and the right to step in and take over a vaccine project if the developer failed to deliver.
The pharma industry immediately objected. Even though they were bankrolled by public money, drug companies were “concerned about the precedent that could be set if they allowed an outside entity, in this case CEPI, to set [the] price of a product unilaterally,” CEPI reported in February. The nonprofit backed down, removing most references to prices in a new policy that Doctors Without Borders called “an alarming step backwards.”
The original policy was intended to be “interim,” and CEPI’s “commitment to equitable access as a principle is the same,” said spokesperson Rachel Grant.
Some thought the worst infectious disease crisis in a century, along with the enormous public investments, would change industry behavior.
Governments could have demanded transparency and low prices. They could have offered developers cash prizes for vaccines that would have incentivized science but let the public retain the marketing rights, said Love, of Knowledge Ecology International.
Agreement by researchers to publish the virus genome in January set the stage for global scientific cooperation, many believed.
“The full sequence was shared with the world without any strings attached,” said Manuel Martin, a U.K.-based adviser to Doctors Without Borders on access to medical innovations.
The World Health Organization set up a “COVID-19 Technology Access Pool” to promote the sharing of patents and other knowledge. Oxford stepped forward and said it would offer nonexclusive, royalty-free licenses for its vaccine, meaning multiple parties could sell it at a low cost.
“I personally don’t believe that in a time of pandemic there should be exclusive licenses,” Adrian Hill, director of Oxford’s Jenner Institute, which is developing the vaccine, told The New York Times in April.
Instead, little has changed. No vaccine maker has offered open licenses, although NIH is sharing key technology it developed with multiple vaccine companies. Governments are signing lucrative deals with manufacturers to ensure vaccines for their own populations. WHO has made no announcements about contributions to its COVID-19 shared technology pool since it launched in May, patent experts said. WHO officials did not respond to a reporter’s queries.
After Oxford announced the exclusive AstraZeneca deal, the company said it would sell vaccines at no profit—but only during the pandemic. Johnson & Johnson’s pledge to earn no vaccine profit is similarly limited.
With financial information kept confidential, no one will be able to confirm whether the vaccines are truly being sold at cost. And if vaccine immunity is only temporary and endemic coronavirus strains require regular shots for years, the companies will make plenty of money down the road, critics say.
Under its deal with AstraZeneca, Oxford will receive no royalties during the pandemic but could make millions after it ends through a web of patents including those held by Vaccitech, a for-profit spinoff. Vaccitech’s ownership includes a 50% stake held directly or indirectly by Oxford and 5.25% each owned by Hill and Jenner’s other top vaccine scientist, Sarah Gilbert, U.K. regulatory filings show.
The potential for vaccine profits at Vaccitech was first reported by The Wall Street Journal.
Pharma company officials say that only decades of industry research could have made it even possible to produce a coronavirus vaccine at the present speed.
“The federal government cannot research, develop and manufacture vaccines and other new treatments on its own,” said Andrew Powaleny, a spokesperson for the Pharmaceutical Research and Manufacturers of America, a lobbying group. Large and early government investment “is a well-accepted approach to addressing public health crises,” he said.
Many argue that a health crisis is not the time to worry about overpaying for vaccines or backing some candidates that won’t deliver. Getting a good vaccine as quickly as possible requires spreading bets, they say.
“Spending some extra billions on vaccines is the right choice when human life is at stake and trillions in economic loss is at risk,” said Edward Scolnick, a top scientist at the Broad Institute and former head of research for Merck. He owns no stock in Merck or other pharma companies, he said.
Oxford backed off from its open-license pledge after the Gates Foundation urged it to find a big-company partner to get its vaccine to market.
“We went to Oxford and said, Hey, you’re doing brilliant work,” Bill Gates told reporters on June 3, a transcript shows. “But … you really need to team up.” The comments were first reported by Bloomberg.
AstraZeneca, one of the U.K.’s two major pharma companies, may have demanded an exclusive license in return for doing a deal, said Ken Shadlen, a professor at the London School of Economics and an authority on pharma patents—a theory supported by comments from CEO Soriot.
“I think IP [intellectual property, or exclusive patents] is a fundamental part of our industry and if you don’t protect IP, then essentially there is no incentive for anybody to innovate,” Soriot told the newspaper The Telegraph in May.
Some see the Gates Foundation, a heavy funder of Gavi, CEPI and many other vaccine projects, as supporting traditional patent rights for pharma companies.
“[Bill] Gates has staked out this outsized role in the vaccine world,” Love said. “He has an ideological belief that the intellectual property system is a wonderful mechanism that is necessary for innovation and prosperity.”
The Gates Foundation requires all its grantees to commit to making products “widely available at an affordable price,” a spokesperson said.
Oxford officials, including Hill and Gilbert, did not respond to requests for comment. AstraZeneca, for its part, would set a “reasonable” post-pandemic price and is “committed to ensure equitable access, globally” in the meantime, a spokesperson said. The company has signed deals with CEPI, Gavi and the Serum Institute of India to bring more than a billion doses to low- and middle-income countries, he said.
If nothing else, governments and vaccine makers should be open about their relationships, including making contracts public, said Duncan Matthews, a patent law professor at the Queen Mary University of London.
“We simply don’t know what’s in these deals,” he said. “The biopharma industry is applying old rules of commercial confidentiality in a situation that is unprecedented.”
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