Waiving intellectual property rights would compromise global vaccination efforts

The resurgence of Covid-19 cases in the United States and around the world, in large part due to the highly transmissible Delta variant, makes it even more crucial to step up the pace of the global vaccination campaign.

To do that, some countries have sought to suspend intellectual property (IP) protections on Covid-19 vaccines and therapies. India and South Africa sponsored a proposal to that effect at the World Trade Organization (WTO). The proposal has since been endorsed by other countries, including the United States. They argue that eliminating IP protections would allow any willing company to produce lifesaving Covid-19 vaccines, making them cheaper and more widely accessible in low-income nations.

If true, that would be a compelling argument. But it isn’t.

Covid-19 vaccines are already remarkably cheap, and companies are offering them at low or no cost to low-income countries. Poor access to clinics and transportation are barriers in some countries, but the expense of the shot itself is not. In fact, if the World Trade Organization grants the IP waiver, it could make these vaccines more expensive.

Here’s why. Before Covid-19 emerged, the world produced at most 5.5 billion doses of various vaccines every year. Now the world needs an additional 11 billion doses — including billions of doses of mRNA vaccines that no one had ever mass-manufactured before — to fully vaccinate every eligible person on the planet against the new disease.

Even as Covid-19 vaccines were still being developed, pharmaceutical companies began retrofitting and upgrading existing facilities to produce Covid-19 vaccines, at a cost of $40 to $100 million each. Vaccine developers also licensed their technologies to well-established manufacturers, like the Serum Institute of India, to further increase production.

As a result, almost every facility in the world that can quickly and safely make Covid-19 vaccines is already doing so, or will be in the next few months.

The cutting-edge mRNA vaccines from Moderna and Pfizer-BioNTech face an even bigger capacity issue. Since the underlying technology is new, there are no mRNA manufacturing facilities sitting idle with operators just waiting for licensing agreements to turn on the machines. Nor are there trained personnel to run them or ensure safety and quality control. Embedding delicate mRNA vaccine molecules inside lipid nanoparticle shells at temperatures colder than Antarctica isn’t as easy as following a recipe from Bon Appetit.

Another big barrier to producing more shots is a shortage of raw materials. Suspending intellectual property protections and allowing any manufacturer to try to produce these vaccines, regardless of preparedness or experience, would increase the demand for scarce raw materials, driving up prices and impeding production.

Nor could all companies that suddenly get a green light due to suspended intellectual property rights produce vaccines as cheaply or quickly as existing manufacturers. Building a new vaccine manufacturing facility costs about $700 million, takes many months — if not years — to build and, once opened, requires another four to six months to start producing vaccine doses. And because negotiations surrounding the WTO waiver, which began this summer, could take until December before they are completed, it wouldn’t be until well into 2023 or later that any additional doses would become available.

That’s slower than our current production rate. According to a report from Duke University’s Global Health Innovation Center, companies are on track to manufacture enough shots in 2021 to fully vaccinate at least 70% of the global population against Covid-19 — the level required to achieve herd immunity.

Covid-19 vaccines are saving millions of lives and protecting trillions of dollars of economic activity for an exceptionally low cost. Israel, for example, which has one of the world’s highest vaccination rates, paid $23.50 per dose for early shipments, for a total of about $315 million. That’s approximately equal to the gross domestic productivity losses incurred during just two days of shutdowns in the country.

Many countries are buying shots for under $10 per dose. India and South Africa — the two countries leading the petition to gut IP rights — are paying just $8 and $5.25 per dose, respectively. For reference, a regular flu shot costs about $14 in the United States, and pediatric vaccines average about $55 per dose.

Meanwhile, low-income countries that can’t afford even modest prices are getting their vaccines at no charge. COVAX, the international nonprofit vaccine distributor, aims to deliver 2 billion doses to developing nations by the end of the year.

President Biden vowed to make America the world’s “arsenal of vaccines.” The U.S. has already committed $4 billion to COVAX, has donated more than 100 million vaccine doses abroad, and is on track to donate 500 million more by the end of summer. Other countries are following the administration’s leadership and ramping up their donations.

To be sure, the United States and other wealthy nations still need to give considerably more. But the fact remains that ramping up production in bona fide facilities and donating doses are the most straightforward steps to producing the vaccine doses needed to end the pandemic. The effort to strip intellectual property rights, by contrast, would put success against the global scourge of Covid-19 even further out of reach.

Michelle McMurry-Heath is a physician-scientist and president and CEO of the Biotechnology Innovation Organization.