In the best-case scenario, sharing patents is only a tiny step in the vastly complex work of making a COVID-19 vaccine, which relies on sophisticated new technologies. At its worst, they say, waiving patents would strain already taxed supply chains and encourage counterfeiting and shoddy production that could result in dangerous or ineffective vaccines, besmirching the reputation of vaccination for years.
Instead of focusing on patents, some say, global leaders should subsidize additional production of existing vaccines at discount prices through groups like Gavi, the Vaccine Alliance, which already funds billions annually in discounted vaccines for the developing world.
Dr. Stanley Plotkin, the inventor of the rubella vaccine and a consultant to vaccine makers, said allowing inexperienced companies to produce vaccines “could be a disaster for covid vaccines and for vaccines in general.”
Plotkin proposed that an intellectual property transfer be allowed to happen only if a regulatory authority, such as the Food and Drug Administration, inspected the receiving company and agreed it was competent.
Proponents of the waiver argue that without urgent action, many more people will die. “At this pace,” 9 of 10 people in the developing world will remain unvaccinated this year ― and it could be “at least 2024” before many nations achieve mass immunization, according to an open letter to President Joe Biden last month from more than 170 Nobel laureates, former prime ministers and heads of states.
“I think we’re going to find very soon that this Canadian company is just a drop in the bucket,” said Niko Lusiani, a senior adviser for Oxfam America who helped gather signatures. “There are many manufacturers ready to come on line.” Even more, he said, there is capacity to be built if those technologies are available and the investors are not facing trade sanctions for doing so.
U.S. Trade Representative Katherine Tai’s statement on Wednesday was carefully worded, saying the U.S. will “actively participate in text-based negotiations” on the global stage to support the waiver. It would require the approval of all 164 member nations.
Tai, picked by Biden in December, met with more than two dozen parties integral to the global vaccine supply chain, including executives of AstraZeneca, Novavax, J&J, Pfizer and Moderna as well as nonprofit proponents of the waiver and Bill Gates. The Microsoft founder and philanthropist, who helped establish global vaccination efforts, has come out in opposition to the waiver. Gates had urged Oxford to commercialize its vaccine after it initially promised to donate the rights to any drugmaker to manufacture for the public good. Oxford gave AstraZeneca sole rights, with no guarantee it would be offered at a low cost, and retained a stake in the profits.
Michael Watson, a longtime vaccine industry official and current consultant to Moderna, called forcing companies to give away their licenses a “dangerous precedent.”
“The problems that we are trying to solve are reliability, quality, cost and access to vaccine supply,” he said. “These can all be done through established market mechanisms of partnerships, licensing, disruptive innovation, tax breaks, incentives and government funding without attacking the market mechanisms that made all of this possible in the first instance.”