Restoring Vaccine Diplomacy

More than 60 years ago, the US and the USSR, while in the midst of the Cold War, collaborated to produce and scale a new oral polio vaccine and test it on millions of Soviet schoolchildren. The 3 poliovirus strains suitable for vaccine production were first developed in the laboratory of Albert Sabin and were sent (with US government approval) to the USSR, where Sabin then worked with Soviet science counterparts, including Mikhail Chumakov. These studies paved the way for the Global Polio Eradication Initiative. Later, in the 1960s, the USSR refined a technique for freeze-drying the smallpox vaccine, making it possible to deliver it intact to remote tropical areas. This innovation helped D.A. Henderson, a US epidemiologist, to lead a global smallpox eradication campaign under the auspices of the World Health Organization (WHO). In both cases, 2 political enemies put aside their differences to collaborate on solving great public health or pandemic threats.¹ Both achievements helped to ignite a modern international framework of vaccine diplomacy for promoting scientific collaboration for vaccine development and ensuring vaccine equity.

Global politics have clearly shifted since the time of Sabin and Chumakov, and the multipolar interconnected world of today is far more complex than ever before. However, the principles of vaccine diplomacy remain intact, as evidenced by the establishment of COVAX, an innovative sharing instrument led by the WHO, the United Nations Children’s Fund, Gavi, and the Coalition for Epidemic Preparedness Innovations, focused on COVID-19 vaccine manufacture and equitable and fair distribution, especially for resource-poor settings.

However, vaccine diplomacy is now under threat by a new vaccine nationalism, in which Russia and China previously conducted unilateral negotiations to promote their vaccines. Although there is welcomed recent news of WHO emergency approval for the Sinopharm Chinese COVID-19 vaccine, this is not yet the case for the others. Russia has reportedly launched clandestine efforts to disparage vaccines made in the US and Europe to promote its own Sputnik V vaccine.² Tragically, this is happening at a time when COVID-19 is surging globally and potentially breaking new records for the number of new daily cases, while overwhelming already underresourced communities and health systems. Therefore, restoring or redesigning vaccine diplomacy in the coming years will require commitment to a large-scale global effort. The 3 top priorities in this global effort are explained below.

Although the COVAX Facility was well-considered to ensure global equity for COVID-19 vaccines once they were produced, the reality is that an adequate supply of vaccines is simply not available. According to the Duke University Global Health Innovation Center, under the current scenario, many low-income nations may have to wait until 2023 or even 2024 to receive sufficient vaccine supply.³ The mRNA, adenovirus-vectored, and protein nanoparticle vaccines from multinational companies are highly innovative in their designs and are proving to be safe and to have high effectiveness in reducing COVID-19–related deaths and hospitalizations. However, similar to any new technology, the barriers to produce these vaccines at massive scale and affordable cost at the outset are high. With the mRNA vaccines, onerous freezer-chain requirements represent additional logistical challenges.

So far, just enough vaccines are being made available for the US, the UK, and Europe, mostly leaving out low-income countries.⁴ More than 1 billion people live in sub-Saharan Africa, 650 million people live in Latin America, and several hundred million people live in impoverished Asian nations. At 2 doses per vaccine, an estimated 4 billion to 5 billion doses of COVID-19 vaccines will be needed to reduce hospitalizations and deaths and ultimately decrease transmission in and from these areas. Yet, except for a few wealthier nations, many African and Latin American countries are almost totally devoid of vaccines. Although India has substantial vaccine development and manufacturing capacity, and has embarked on the vision to be the world’s leading vaccine supplier, its March 2021 announcement to suspend its COVID-19 vaccine exports to meet the country’s own rising internal demands⁵ (if not rescinded) will worsen the already dire global supply and vaccine divide.

True vaccine diplomacy requires that the US, UK, and European nations equitably share their vaccine stocks through COVAX, but even this approach will not be sufficient. For example, even if the US releases all of its unused COVID-19 vaccines, it would only provide a small fraction of the billions of doses required. Therefore, in the near-term, the Biden administration must look into mechanisms to fill those gaps by supporting the production and scale-up manufacturing of COVID-19 vaccines. Although this is not the exclusive responsibility of the US, the nation has the greatest means for embarking on global COVID-19 vaccine demands.

Over a longer period, the pandemic is a reminder of the importance of building vaccine development capacity, especially in Africa (where almost no vaccines are produced) or in Latin America, which has underachieved thus far in producing COVID-19 vaccines locally. This is not a quick fix. Although many point to the urgency of lifting patent restrictions on vaccines, such intellectual property constraints may be of greater relevance to small-molecule drugs than vaccines. The barriers for vaccines are the technical understanding and expertise to produce these complex technologies and provide adequate quality control and assurances. Surmounting such obstacles will require investments in new production facilities and factories, but even more challenging is the shortage of trained staff and scientists who know how to produce new high-quality vaccines and embrace the latest regulatory science. Addressing this situation will require collaboration of scientists across multiple nations and effective programs of international cooperation and assistance. Eventually, vaccine production in Africa and Latin America, like in India (which is already estimated to be able to produce more than 60% of the global supply of vaccines), could become largely self-sustaining. As suggested by Prahalad, the “bottom of the wealth pyramid” low-income markets actually represent extraordinary and sustainable business opportunities.⁶

COVID-19 vaccines that use more traditional technologies, such as whole inactivated virus vaccines, are now available from China (Sinovac and Sinopharm) and from Bharat Biotech in India (Covaxin). More than 160 million doses of the Sinovac whole inactivated virus vaccine⁷ were sent to countries globally, but without review by a stringent regulatory authority as defined by the WHO. This is also true of the Russian Sputnik V adenovirus-vectored vaccine. Although both China and Russia are working diligently to address this situation, the current consequences of unilateral “vaccinationalism” are concerning. For instance, the Agência Nacional de Vigilância Sanitária, the Brazilian regulatory authority, recently rejected Sputnik V due to quality concerns, although their findings are disputed by the Kremlin.⁸ Moreover, in many low- and middle-income countries that often lack adequate pharmacovigilance mechanisms, in which Chinese and Russian vaccines are widely distributed, does Sputnik V cause cerebral thrombotic events similar to the other adenovirus-vectored COVID-19 vaccines? So far, there is no evidence for this, but without adequate surveillance in many nations, it may be impossible to know. Vaccine diplomatic cooperation must be restored between Russia or China and the US or European nations as part of a multilateral global framework, while continuing to encourage and support stringent regulatory reviews.

In contrast to the mid-20th century when the US and USSR cooperated through vaccine diplomacy, the current Russian government has moved in a very different direction. Reports from both US and British governments have revealed how Russia has engaged in efforts to impugn the integrity or safety of Western COVID-19 vaccines through social media and other communications.^2,9,10 Disinformation from US antivaccine nongovernmental organizations and political extremist groups also spreads vaccine doubts across the US and into Western Europe.^9,10 Although adenovirus-vectored COVID-19 vaccines could be mass-produced for low-income countries, Russian and US antiscience inflates the legitimate concerns expressed by the US and European stringent regulatory authorities.^2,10 Whereas in the past, government and international agencies dismissed such disinformation to avoid amplifying their ignominious messages, this may no longer happen. Antivaccine and antiscience aggression requires confrontation.

Vaccinating the many billions of people in low- and middle-income countries will require far higher levels of creative equitable international cooperation and innovative low-cost manufacturing and supply chains than currently are in place. In addition to supporting India's global efforts, it will be essential for the US government to begin shaping a comprehensive foreign policy for vaccine diplomacy, along with counteracting antiscience sentiments and building local capacity. To decisively control the pandemic will require confronting the monumental task of providing 4 billion to 5 billion doses of COVID-19 vaccine to the world’s low-income and low-resource populations. This will not happen without strategic vaccine diplomacy.

Corresponding Authors: Peter J. Hotez, MD, PhD, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030 (hotez@bcm.edu); K. M. Venkat Narayan, MD,1518 Clifton Rd NE, Atlanta, GA 30322 (knaraya@emory.edu).

Published Online: May 28, 2021. doi:10.1001/jama.2021.7439

Conflict of Interest Disclosures: Dr Hotez reported being a developer of vaccines against COVID-19 and other coronaviruses as well as neglected tropical diseases, including Chagas disease, hookworm, schistotomiasis, and leishmaniasis, in which the vaccine technology is owned by Baylor College of Medicine and nonexclusively licensed to Biological E, one of India’s big vaccine manufacturers, that are either in development or clinical trials, for which he has not received compensation or remuneration. Dr Narayan was partly supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (award numbers P30DK111024 and 3P30DK111024-05S1).

Disclaimer: The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.