Eric Stoner’s commentary, “Make America admired again as the arsenal of vaccine” (Opinion Exchange, Oct. 14, 2021) contained some naive and misinformed ideas if put into practice.
Stoner calls out vaccine developing pharmaceutical companies and singles out Pfizer Pharmaceuticals, manufacturer of the lifesaving Pfizer-BioNTech COVID-19 vaccine to “relinquish its patents and share the technical know-how to manufacture the vaccine.” Stoner believes to not do so is “morally reprehensible” and also “dangerous.”
We all can agree that for this pandemic to end, we need to work together to quickly expedite the distribution of safe vaccines around the world. Yet the very policies that Stoner advocates will likely do just the opposite and will have a crippling effect on future biomedical research and development. Most important, waiving vaccine patents would likely not increase the timely vaccination of a single individual in the developing world.
U.S. patent protection “incentivizes” researchers to conduct bold and risky research with the hope of creating the next breakthrough or even lifesaving pharmaceutical advancement. According to the National Institutes of Health, this risky and expensive research often produces failure. But, “after accounting for all these failures, it costs almost $3 billion, on average, to bring a single medicine to pharmacy shelves.”
Pharmaceutical investors understand these inherent financial risks yet remain willing to invest in a brighter future because of the strong patent protections offered to them in the United States. President Abraham Lincoln, the only U.S. president to ever hold a patent, famously said, “Patents add the fuel of interest to the passion of genius.” The miraculous research that ultimately developed into the Pfizer-BioNTech vaccine in a relatively short period of time proves our system of private innovation with government patent protection works. It’s important to note that Pfizer did not accept any U.S. taxpayer money to fund their COVID-19 vaccine research.
These anti-patent coalition members like Stoner and his fellow traveler Sen. Bernie Sanders tell you that waiving existing U.S. law is necessary for humanitarian reasons: to quickly vaccinate the world. Yet they naively neglect to mention that even if pharmaceutical manufacturers shared the “design” of their vaccines, that would not end the pandemic.
Both Pfizer-BioNTech and Moderna created their vaccines from a newer messenger RNA technology. If these two companies shared the formula today to create these complex biologics, it is highly unlikely that untrained labs around the world would be able to successfully replicate these lifesaving innovative medicines. Dr. Rajeev Venkayya, president of the Global Vaccine Business Unit at Takeda Pharmaceuticals and former director of vaccine delivery at the Bill and Melinda Gates Foundation’s Global Health Program has been educating the public about the extremely complicated methods needed to successfully produce these vaccines. “Every aspect of vaccine manufacturing is tightly controlled: raw materials, equipment, production processes, training, operating procedures, etc. All of it happens under GMP [good manufacturing practice] regulations, and facilities are regularly inspected.”
All of these factors contribute to the safety in making and distributing vaccines. Just sharing the “design” of this complex vaccine manufacturing process oversimplifies an extremely complex and costly process — one unlikely to be replicated in a developing country with little or no experience in the vaccine manufacturing process. A better solution is already happening: Pfizer and Moderna are already speeding up vaccine production. Pfizer has committed to produce over 1.1 billion doses at cost. These doses will be shared globally and citizens around the world can be certain that each does is safe and created by a reliable (and highly regulated) production facility.
Last month President Joe Biden challenged wealthy nations around the world to join the United States “to do more to end the pandemic.” According to National Public Radio, “the U.S. has shipped almost 160 million doses [of the vaccine] to 100 countries around the world, a number that exceeds all other donations combined.” American ingenuity and generosity are on course to vaccinate over one-fifth of the world. And all of this is being done today without waiving U.S. patent protection that would endanger the critical research and drug development necessary for when the next global pandemic strikes. That’s the right way and the American way.