It was a surprise, and a welcome one. Last month, the Centers for Disease Control and Prevention announced that masks and social distancing were no longer necessary for the fully vaccinated. But the sense of relief may be premature. The spread of the disease has fallen sharply here, but around the globe it is moving with breathtaking speed—and dire consequences for the United States as variants arise and threaten us. In India, only 3 percent of the population has been inoculated. More than 1,000 doctors have died of Covid. Hospitals are overrun and corpses wash up on the banks of the Ganges. Even Italy, the first European nation pummeled by the virus, has fully vaccinated less than 6 percent of its population.
Getting the planet vaccinated is the global public health priority.
So, the question is, how to get shots into the arms of 7.9 billion people? (Only 413 million persons have been fully vaccinated, most in wealthy nations.) This month, the Biden administration announced it would make more than 500 million doses available to other countries, prioritizing those most in need of the shots.
It’s a huge gesture, but that still leaves a gap of 8-10 billion additional doses, and that’s not even counting the booster shots that may be needed if Covid hangs around. Current vaccine manufacturers—even big companies like Pfizer and Johnson & Johnson—don’t have the capacity to churn out enough vials in time to prevent the appearance of more variants, which are most likely to develop in places where the virus is being passed rapidly from person to person. The CEO of the Serum Institute of India, a biotech and pharmaceutical company which produces 60-70 percent by volume of the world’s vaccines, predicts that at the current rate of global production there won’t be enough Covid vaccine to inoculate the world until 2024.
One way to achieve global vaccination is to recruit the makers of generic vaccines, most of which are made outside the U.S. To that end, the White House is supporting emergency patent waivers. These waivers, which must be granted by the World Trade Organization (WTO), would give generic manufacturers the legal right to produce shots without fear of litigation from the pharmaceutical companies that developed the vaccines and hold the patents.
The People’s Vaccine Alliance, supported by organizations including Oxfam, Public Citizen and UNAIDS, is lobbying wealthy nations and the WTO not only to support waivers, but also to set up the means for low- and middle-income countries to provide vaccines at cost or for free. The alliance argues that shared knowledge regarding the vaccines should be “freely available to everyone everywhere” as a global common good. The WTO has agreed to put the discussion of waivers for Covid vaccines on an accelerated timeline. That means instead of the deliberations over patent waivers grinding along for years, the WTO could make a ruling in a matter of months.
Not surprisingly, most vaccine makers and their Republican allies are fiercely opposed to patent waivers, saying they run “counter to long standing American values.” Several European leaders and even some American liberals oppose waivers and dismiss them as “symbolic.”
The Pharmaceutical Research and Manufacturers of America, the industry’s biggest trade group, has claimed that patent waivers will deprive drug makers of needed materials, flood the market with low-quality products, and remove the incentive to invent new medicines. This last argument laughably ignores the federal government’s contribution. American taxpayers fund the majority of basic research that goes into the development of drugs and vaccines. In the last two years, the federal government guaranteed multibillion dollar payouts to Moderna, Pfizer and others to purchase their vaccines and government-financed research was invaluable to the development of the Covid shots. Pharma is also worried that waivers for Covid will set a precedent for patents being waived rapidly during global health crises. The People’s Vaccine Alliance and its signatories are certainly hoping that’s the case.
But patents are only half the battle towards global inoculation. Just as crucial as the right to manufacture the vaccines are the step-by-step instructions for how to make them. Generic companies need the “technology transfer,” precise information about the chemical ingredients and processes for making the vaccines. Manufacturing the mRNA vaccines involves building the genetic string, the mRNA, and then wrapping it in a ball of fat so it can get into the muscle without breaking down. This is a lot trickier than making old-fashioned vaccines, which involves growing viruses in chicken eggs. Without the technology that patent holders have developed, it could take years for the generics to figure out how to do it.
If the patent holders won’t share their expertise, there are other ways to provide generic vaccine makers with the necessary technology. The Biden Administration could invoke statutes that permit the president to force private companies to share information, such as the Defense Production Act (DPA), enacted during the Korean War to ensure the supply of war materials. According to Peter Maybarduk, director of Public Citizen’s Access to Medicines program, under the DPA the President could require vaccine makers to share their technology and provide training for personnel at generic companies.
In return, the vaccine manufacturers would be compensated for what they share, taking into account the funding they already received under Operation Warp Speed. The DPA also allows the Biden Administration to pay vaccine manufacturers to repurpose facilities and produce Covid vaccines. Public Citizen estimates that 14 facilities could produce 8 billion vaccines within a year to 18 months for $25 billion.
There’s one other way to get the knowledge transferred to generic manufacturers, says James Love, the director of Knowledge Ecology International which advocates for the public interest in intellectual property matters. His idea is for the federal government to purchase licenses from vaccine makers. Vaccine and drug companies regularly enter licensing agreements with other manufacturers, giving the licensee the information needed to make the product and sell it, usually for a hefty price. For example, British vaccine maker Astra Zeneca has licensed its Covid vaccine to the Serum Institute of India to make a billion doses.
Love wants wealthy countries to speed up vaccine manufacturing by buying licenses from vaccine patent holders. Those licenses would then be given to generic manufacturers and would include the technology transfer that’s needed. “Instead of begging people to do the right thing,” says Love, “Why not offer money?”
That the U.S. government might end up paying vaccine makers for taxpayer-funded technology underscores one of the most glaring failures of Operation Warp Speed, which cost $18 billion as of October: The Trump administration’s plan to quickly develop a Covid vaccine never included compulsory licensing requirements to ensure the vaccines would be globally available. Other countries, which financed their own vaccines, also failed to insist on compulsory licensing.
President Biden has an opportunity to fix this. In addition to his support for patent waivers, which will set a precedent for ramping up the world’s drug and vaccine manufacturing capacity in the next pandemic (and there will be a next pandemic), he can announce a plan to ramp up vaccine production worldwide, either by invoking the DPA or buying licensing rights. The alternative is to wait for patent holders to produce enough vaccine. With the rise of multiple variants of Covid-19, that will take years – and no one will be safe.
