Have we learned anything? Lessons from COVID-19 and a Call for Vaccine Diplomacy over Nationalism in the Coming Age of Pandemics
Authors (alphabetically): Marine-Ayan Ibrahim Aibo*, Lindsey R. Fernandez**, Kaeri M. Medina*, Stefan T. Peterson*
*University of Pennsylvania, Perelman School of Medicine
**University of Pennsylvania, School of Engineering and Applied Sciences
Inequality in vaccine development and access between lower income nations and wealthier ones persisted throughout the COVID-19 pandemic as nationalistic procurement programs succeeded over global coordination efforts. The world remains vulnerable to future variants as this inequality continues, and the high risk of future pandemics prompts the need for preemptive solutions.
More deaths and prolonged pandemic due to poor global vaccine distribution
The COVID-19 pandemic has highlighted the issue with global equity of access to vaccines. While wealthy nations have given citizens access to multiple doses of vaccines, one third of the world still has not received a single dose. Uneven vaccine distribution has led to multiple variants of SARS-CoV-2, and high income countries (HICs) cannot boost their way out of this phenomenon. Global coordination is necessary for dealing with pandemic viruses that threaten lives and livelihoods. Modeling has shown that cooperative strategies to allocate vaccines during the current pandemic could have saved 61% of lives that were lost. While US citizens are developing relaxed attitudes towards COVID-19, the rest of the world is still grappling with this virus. We are entering an age of pandemics, and there is a need to be prepared to distribute vaccines quickly and equitably to all populations around the world.
How are vaccines funded and produced?
Development of vaccines is a long and expensive process with a failure rate of 94%. Private investors in this research and development process are understandably cautious and eager to recoup money. However, it is important to recognize that in the US, funding from the National Institutes of Health has provided a basis for every new drug approved from 2010–2019, totaling $230 billion. Despite large public investment, Americans are not guaranteed that resulting drugs will be financially accessible. Public investment in vaccine development is critical for working on vaccines that might risk lack of profits.
The remarkable and rapid development of COVID-19 vaccines was made possible by the US federal government’s decision to employ a strategy of “de-risking.” Operation Warp Speed (OWS), started in April 2020, is largely considered a success due to these tactics. By purchasing 300 million doses of vaccines without knowing their effectiveness, the US government enabled companies to develop vaccines quickly without delay. OWS also developed open communication between vaccine makers and regulators, and coordination between different regulatory agencies across the world to streamline the review process. While this led to the development of multiple COVID-19 vaccines, nationalistic pursuits muted any plans for global distribution. Companies were allowed to control manufacturing as they saw fit, leaving low and middle income countries (LMICs) to bid for manufacturing licenses and vaccine doses unsuccessfully against wealthier ones for access.
The most notable program for international distribution of COVID-19 vaccines is the COVAX program run by the World Health Organization, the Center for Epidemic Preparedness Innovations (CEPI), and Gavi, the Vaccine Alliance. COVAX set ambitious goals from the beginning by aiming to deliver two billion doses of COVID-19 vaccines by the end of 2021. Without independent funding, the organization relied on HICs for their capital and manufacturing capabilities. These countries exacerbated the lack of access to vaccines by hoarding shipments and imposing export bans. This program’s failure highlights how there needs to be proactive plans that aid LMIC vaccine independence in order for equitable distribution of vaccines during a pandemic.
Challenges and opportunities for equitable global manufacturing of vaccines
During the COVID-19 crisis, lower income countries were unable to sufficiently vaccinate their populations despite the support of wealthier countries. LMICs must be able to produce their own vaccine supply to allow equitable vaccine access in future outbreaks and pandemics. However, the international legal landscape and supply chains favor those with greater spending power, whether private entities or entire countries.
The 1995 World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) established the standards for international drug patent enforcement. Pharmaceutical companies in HICs improved their market dominance through TRIPS, leaving LMICs without a route to equitable access to medical technologies. Fewer countries are able to create or afford patented drugs and LMICs often do not have their own domestic drug companies to fill this need. This lack of access can, in part, be attributed to TRIPS. This agreement set a precedent allowing the pharmaceutical industry and HICs to rapidly distribute beneficial technologies to their own citizens first, leaving LMICs with little access to vaccines and increasing inequality during the pandemic.
Resource hoarding by HICs presented another substantial barrier to equitable access. Patents are not specific protocols, meaning products protected by the patent are not easy to replicate. The information and expertise for making patented COVID-19 vaccines was not publicly shared by wealthier nations and companies. LMICs had to attempt to reverse engineer existing vaccines or create new ones at the expense of already limited resources and time. Even with the expertise and facilities to make vaccines, LMICs would not have been able to outbid large companies like Pfizer for the reagents needed to make them.
In light of these challenges, we believe a multi-tiered hierarchy of needs must be addressed to ensure that LMICs have access to vaccines during pandemics (see Figure 1). Interventions to ensure knowledge sharing, supply protection, and pandemic preparedness must be implemented in tandem to overcome current barriers to LMIC vaccine access and global vaccine equity.
Recent Developments and Recommendations
Introduction of US Senate bill S.4062 No Free TRIPS Act and US House bill HR. 7430 Protecting American Innovation Act
These two bills, recently introduced in both chambers of the US congress, limit presidential power to allow the release of manufacturing intellectual property of lifesaving vaccines. These bills would benefit US-based pharmaceutical company profits. A US move towards more restrictive IP sharing, especially during emergency situations like pandemics, would cause recurring inequity in global vaccine access.
Recommendation: Do not pass S.4062 or HR.7430 in order to keep flexibility for emergency patent waivers in the hands of the president.
Calls for international organizations to increase funding and restructure pandemic preparedness and response plans.
The G20 High Level Independent Panel on Financing the Global Commons for Pandemic Preparedness and Response has recommended that G20 international leaders increase funding in the face of the oncoming era of increased pandemics. Funding from HICs will only be as good as the infrastructure developed before the next pandemic. Quickly accessible IP and manufacturing protocols for LMICs will be necessary for an effective pandemic response.
Recommendation: In addition to increased funding from HICs, develop plan to centralize pandemic vaccine intellectual property for use by LMIC manufacturers.
Moderna drops fight to block NIH name on patent
Moderna spent months in 2021 in a battle to prevent a US government stake in one of Moderna’s COVID-19 vaccine patents. Billions in US funding have already gone to the basic science and development of multiple COVID-19 vaccines. Having NIH researcher names on a patent could give the US government more of a say in which companies manufacture the vaccine. If LMIC companies were allowed to manufacture the vaccine, there could be more equitable global access.
Recommendation: Federal (aka public spending) should be used as lever for countries to enforce international access to complete manufacturing protocols for emergency vaccines.
