International Vaccine Inequity is the Problem, But a Vaccine Patent Waiver is not the Solution
Disclaimer: This article was originally written June 30, 2021 and in light of the evolving global COVID-19 situation, data and trends may have evolved as well
After a year of dealing with the COVID-19 outbreak, the focus has turned from mitigation to eradication. The miraculous expedition of COVID-19 vaccines from companies worldwide has presented new challenges in vaccine implementation and inequity. While wealthy nations that either host companies that develop vaccines or can afford to purchase doses have begun to administer doses, other countries continue to be ravaged by the pandemic. Countries in South America and Asia are particular hotspots at the moment. There are still 1,664.1 average daily deaths from the virus in Brazil, with the 14-day average for cases increasing by six percent.1 India’s condition, which has slowly improved since the recent explosion in cases and deaths,2 still has an average daily death rate of 1,227.9, even after the 14-day average for daily deaths fell by 66%.3 For reference, the United States’ average daily death rate is at 307 and dropping quickly.4 As countries like Israel and the United States’ percentage of fully vaccinated individuals are at around 50% and climbing, Brazil only has 12% fully vaccinated, and India only has 4% fully vaccinated.5 Even worse, Brazil and India are relatively wealthy compared to poorer nations that are faring significantly worse in regards to vaccination access. Only two people per 100 have been administered a vaccine in the African continent compared to 68 doses per 100 people in high-income countries.6 Less than one percent of the African population has been fully vaccinated and significantly less than that in the region's poorer countries.7 And while these figures pose an inherent danger due to sickness and loss of life, there is economic distress to the United States and the global economy that accompanies vaccine inequity as well.
Globalized trade and the interconnectivity of national economies will cause economic damage to countries whether they contain a vaccinated population or not. A study commissioned by the International Chamber of Commerce concluded that if wealthy nations were fully vaccinated by the middle of 2021 while poorer countries retained low vaccination rates, the global economy would lose $9 trillion over time.8 This presents a decision for government officials between ensuring a quick and effective vaccination of their population and spreading their technology and doses worldwide to aid global citizens, protecting their economic interests. Vaccine nationalism is understandable for governments seeking to protect their citizens first but will cause other countries to suffer longer from the pandemic and reduce their own GDPs. A study from the RAND institute in Los Angeles estimated that the yearly global GDP loss without a vaccine would be around $3.45 trillion, with most of that lost being absorbed by wealthy countries.9 However, even with a vaccine, if only the countries that developed vaccines had access, the yearly loss would still be $1.23 trillion.10 If only high-income nations had vaccine access, global GDP loss would be around $292 billion a year.11
An example of where these losses would occur can be seen in the United States’ eighth largest trading partner: Vietnam. While we only export $3.8 billion to Vietnam a year, we import $31.2 billion a year in trade.12 While Vietnam was mostly spared during the first year of the pandemic, cases have recently climbed by 35% in the past 14 days.13 Recent outbreaks in Northern factories and Ho Chi Minh City have led to more than half of the country’s total cases occurring in only the month of May alone.14 According to Tran Van Phuc, a doctor in Vietnam, the countries “next 12 months will be the most difficult in controlling the number of infections so as not to overwhelm the health system and limit the number of deaths,”15 the same phase countries like the United States were in a year ago. But while many countries now have access to vaccines, only 0.2% of Vietnam is fully vaccinated, meaning nationwide lockdowns will likely be coming to mitigate the spread. These lockdowns will entail a significant decrease in production that will affect Vietnam’s GDP as well as the United States’ supply and cost of goods unless Vietnam can quickly maintain the outbreak or receive more vaccines for their population.
The United States currently has the largest amount of vaccine doses globally, but now is suffering from a lack of demand. While America was administering around 3.3 million doses a day in April, that number has dropped to 870,000 a day in June.16 States like Oklahoma have more than 700,000 doses on shelves but only administer 4,500 a day, with 27,000 Pfizer and Moderna doses soon to expire.17 In addition to attempts to drum up demand, the Biden administration has looked to donating its extra doses to other countries. In May, President Biden announced his intention to donate 80 million doses of vaccines.18 The United States is not alone in their donation efforts, as France pledged 30 million doses, China pledged 15.2 million, and India pledged 10.2 million.19 But not every country has avoided the temptation of vaccine nationalism. The United Kingdom has ordered over 500 million doses of vaccines for its population of 67 million but still plans to hold off on donations until the population is completely vaccinated nationally, including children.20 Britain’s Health Secretary Matt Hancock described how as soon as doses are “available for the UK, [they] get them injected into British arms.”21 While Britain does not suffer from the same level of vaccine hesitancy as the United States, allowing more of their doses to be used, their usage of the doses for children between the ages of 12-15 has drawn criticism. Global health experts have warned that rich countries prioritizing low-risk populations like 12-15 year olds over broadened global access could risk health and economic disaster worldwide.22
The current global vaccine market includes United States companies, international companies, and several state-owned initiatives. Two United States companies, Pfizer and Moderna, comprise more than 60% of the global market and utilize the revolutionary mRNA vaccine, with 35% and 78% being sold to the American market, respectively.23 Additionally, for American companies, Johnson and Johnson’s vaccine sold $100 million of its vaccine in the first quarter of 2021 exclusively to the American market, and Gilead Sciences sold $1.73 billion in the first quarter of 2021, with 56% being in the United States. The British AstraZeneca vaccine sold $275 million in the first quarter of this year as well. These vaccines make up the bulk of the vaccines coming from Western countries, which is a distinction that is important for global vaccine access. Russia’s Sputnik V came from Russia’s government and is being used in countries such as India. China has two vaccines, one from Sinovac, a publicly traded pharmaceutical company, and the other from Sinopharm, which is state-owned. India has been using Covishield, the Indian-made version of AstraZeneca, but has several other vaccines beginning to make their rounds, such as the newly developed Covovax.24 All of these vaccines use different technologies to protect against the coronavirus, leading to geopolitical obstacles in internationalizing the technology, which the vaccine waiver would do.
The arguments for a vaccine patent waiver are fairly self-evident. A select few companies with limited manufacturing capacity control the supply of vaccines, and waiving patent protections of the technology would allow countries currently without access to begin manufacturing independently. Even when the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights was signed in 1995 and included pharmaceuticals like vaccines, it was condemned by many economists and health experts.25 That warning is being heeded today as a coalition of countries led by India and South Africa proposed a waiver in May of 2021 to the World Trade Organization.26 While the United States was initially not part of the proposal, President Biden announced his support later that month despite the United States’ long history of intellectual property protection.27 Waiving these patents, however, comes with a host of other problems that outweigh any potential for good that the waiver may promise.
The first problem is the future impact on innovation. Intellectual property protection incentivizes the development of new technology, and a breach in that trust could discourage companies from researching vaccines for future diseases. While Moderna and Pfizer recently developed the specific vaccine for COVID-19, the mRNA technology began being researched years ago. Without the incentive that patents provide, it is less likely that companies will commit the time and resources to the development of future vaccines. These years of research also take the form of geopolitical concerns. While the Biden administration has hesitantly backed the vaccine waiver, they are still searching for ways that the waiver would not hand sensitive American biopharmaceutical technology to countries like China and Russia.28 The United States currently enjoys industry superiority over its adversaries, but a vaccine waiver could allow Russia or China to leapfrog years of research in which American companies spent their resources.
The short-term issues with a vaccine patent waiver are its ineffectiveness. While the companies that are producing vaccines have a limited number they can supply globally, it is not the patent protections that are creating the vaccine-supply bottleneck, but rather the required materials.29 Pfizer CEO Albert Bourla claims that the limited supply is due to raw materials that are “highly specialized raw materials… not simple chemicals.”30 Even if countries were allowed to use the patented technology of developed vaccines, the rush to acquire these rare materials could potentially cause an even more significant bottleneck than the current vaccine supply shortage. For example, mRNA vaccines require rare materials like polymerases, an enzyme that converts DNA to mRNA, and vaccinia capping enzymes that keep the mRNA from degrading.31 Prior to the pandemic, these materials were only produced in the amounts required for research purposes, not meant for the production of billions of doses, as evidenced by Pfizer cutting their estimated production by half in November of 2020.32 Patrick Boyle, an executive dealing with research and development at the synthetic biology company Ginkgo Bioworks calculated that even producing the ten pounds of vaccinia capping enzymes that would be needed for 100 million mRNA vaccine doses would overwhelm the capacity of the bioreactors used to carry out biochemical reactions.33 This limited supply of raw materials being vied for by countries worldwide would only worsen vaccine nationalism and decrease production efficiency.
This introduces the next reason a patent waiver would not dramatically increase vaccine supply: production challenges. Even if there was an ample supply of the raw material, many countries in desperate need of vaccines don’t have the infrastructure to begin production immediately. Dr. Michelle McMurry-Heath, the chief executive officer for the Biotechnology Innovation Organization, provides the analogy that “handing needy countries a recipe book without the ingredients, safeguards, and sizable workforce needed will not help people waiting for the vaccine.”34 With only the raw materials, companies would not be able to sustain production, and it would take at least two years to scale up their biopharmaceutical infrastructure to adequate levels.35 While it would take this amount of time to scale up production infrastructure, the ten companies currently producing vaccines have production targets for 2021 that would be enough to vaccinate 93% of the population, meaning moves to encourage production in other countries than the ones currently producing would be a fruitless endeavor.36
The main reason why less-wealthy countries are receiving such a low amount of vaccine doses is that the companies manufacturing the vaccines are hesitant to scale up their production capacities without pre-purchase agreements. While countries like the United States and the United Kingdom have the capital to pre-purchase large amounts of vaccines, poorer countries do not, leaving wealthy countries with such a disproportionate amount of the early doses.37 There are several options to help provide these countries with vaccines sooner. The first is to provide funding through the World Health Organization or wealthy countries for these pre-purchase agreements. In combination with donations of excess dosages from countries like the United Kingdom that ordered over 500 million doses for their population of 67 million, this funding could help poorer nations acquire the vaccines they need in a much more expedient timeline than a vaccine waiver.
Another problem is in the form of the solutions offered by the World Bank. The World Bank, an intergovernmental organization and investment bank with 189 member countries, approved loans for 41 countries amounting to almost $4 billion for vaccine rollouts.38 This program from the World Bank allows poorer nations to receive loans to cover their pre-purchase agreements. The issue lies in which vaccines can be pre-purchased with loans from the organization. The World Bank currently only allows loans for vaccines approved by what they call ‘Stringent Regulatory Authorities’ (SRAs).39 These SRAs, however, fall into only three categories. The first is the European Commission, the executive branch of the European Union, the next is the United States Food and Drug Administration, and the last is the Ministry of Health, Labour and Welfare of Japan.40 Other countries that either observe or are associated with an SRA, such as Canada, Australia, or Iceland, are also included.41 Notably, this excludes countries like Russia, China, or India. This is partially due to the geopolitical makeup of the SRAs, with most if not all being NATO allies rather than adversaries like Russia and China, and leads to the prioritization of vaccines coming from members’ own countries for the economic benefits that accompany them.42 Vaccines from China, Russia, or India are not eligible for loans from the World Bank for pre-purchase agreements. This is despite the Russian Sputnik V vaccine showing a 91.6 efficacy rate after two doses,43 the Chinese Sinopharm vaccine having an efficacy rate of 79% against symptomatic COVID-19 and hospitalization,44 the Chinese Sinovac vaccine having a 51% efficacy rate against symptomatic COVID-19 but 100% against severe cases and hospitalization,45 and Covocax, India’s local version of the American Novovax vaccine, proving to be 90% effective in late-stage clinical trials in the United States.46 All of these vaccines help protect against symptomatic COVID-19 and potentially its contagion. More importantly, all have proved to dramatically decrease (if not eradicate) the chance for severe cases of hospitalization. Decreasing the hospitalization and death rates would dramatically reduce the human impact from this pandemic as well as mitigate the economic damage done to wealthy nations that had a company develop a vaccine in their country. Ditching these geopolitical rivalries for international aid through donations by wealthy countries and reconstituting the eurocentric requirements for World Bank loan eligibility would allow the financial freedom for private vaccine companies to expand their production while protecting lives and mitigating economic damage the coronavirus pandemic has already dealt.
Many of us look to the fact that large corporations control much of the global vaccine supply and assume that giving the vaccine recipe to struggling nations will reduce the frustrating inequity in vaccination access. Unfortunately, like most things, the answer is more complicated. Providing a vaccine patent waiver would not only potentially hinder its supply but damage the United States’ international standing in the pharmaceuticals industry by giving our adversaries a chance to catch up to the biopharmaceutical superiority many of our American companies have worked to maintain. A mad rush by each country for limited materials would only increase vaccine nationalism and slow the dispersal while also disincentivizing future research and development efforts for the next pandemic that is likely to occur. The waiver idea serves as a kind of ‘red herring’,47 that is more symbolic than substantive. The rush for raw materials would create more problems than solutions, and the lack of production infrastructure would mean many countries would take years even to begin to sustainably manufacture a vaccine. With the current production targets by the companies that are presently producing, the quickest and most effective way to get less wealthy countries’ populations vaccinated is through donations from nations that have surpluses, as well as revisiting which vaccines are eligible for pre-purchase loans through the World Bank. These policy changes worldwide would have the best chance of achieving a proper multilateral solution to vaccine distribution. While there may be domestic policies related to pharmaceuticals in the United States that require amendment, intellectual property protection should be non-negotiable both for the purpose of its fundamental long-term goals, as well as the waiver proposal’s ineffectiveness.
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43. Ian Jones and Polly Roy, “Sputnik V COVID-19 Vaccine Candidate Appears Safe and Effective,” The Lancet 397, no. 10275 (February 2, 2021): pp. 642-643, https://doi.org/https://doi.org/10.1016/S0140-6736(21)00191-4.
44. “The Sinopharm COVID-19 Vaccine: What You Need to Know” (World Health Organization, May 10, 2021), https://www.who.int/news-room/feature-stories/detail/the-sinopharm-covid-19-vaccine-what-you-need-to-know.
46. “Moderna, Covovax, Biological E: What We Know about India's New Covid Vaccines,” BBC News (BBC, June 29, 2021), https://www.bbc.com/news/world-asia-india-55748124.
47. “US Talk of Waiving Vaccine Patents Is Merely Symbolic: Experts,” Yahoo! Finance (Yahoo!), accessed June 29, 2021, https://finance.yahoo.com/news/us-talks-on-vaccine-patent-waivers-appears-symbolic-experts-214914469.html