Poorer nations face tougher choice about vaccines

When the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) advised a pause in use of the Johnson & Johnson COVID-19 vaccine on April 13 to better study the potential for very rare blood clotting-related adverse events, there was little short-term disruption to worry about in the U.S. There are already tens of millions of doses of Pfizer and Moderna vaccines awaiting administration, and a total of 600 million doses expected by July — enough to vaccinate every adult and child 12 and up. 

When the government of South Africa followed the U.S.’ lead and paused use of this vaccine in a “precautionary measure,” it had the more dire consequence of stopping all vaccinations in the face of an ongoing public health emergency.

The COVID-19 global pandemic rages on despite the development of multiple safe and effective vaccines in record time. With over 145 million infections and more than 3 million deaths globally, the pandemic is worsening in many parts of the world, including countries in Latin America, South Asia and Sub-Saharan Africa. While almost a billion doses of vaccines have been administered, access remains highly inequitable; the U.S., European Union, China and India account for over 70 percent of all vaccinations.

The world closely watched the U.S. and EU leaders as they made decisions on use of the Oxford-AstraZeneca and Johnson & Johnson COVID-19 vaccines due to the potential links to very rare clotting adverse events, now labeled Thrombosis with Thrombocytopenia Syndrome (TTS). While the communications related to these decisions and guidance focus on domestic audiences, which is appropriately the mandates of these organizations, they nevertheless can have a profound influence on global vaccine implementation and confidence, as we saw last week with the South African pause in vaccination.

Each nation is responsible for the regulation of medical products in its own country. However, regulators and policy-makers in high-income nations — especially the U.S. — can support more effective global decision-making and vaccine confidence. Communicating clearly about the risk-benefit calculations they are making and the factors that could change those calculations puts their decisions into proper perspective for global audiences. 

The U.S. week-plus pause for review of data about the Johnson & Johnson vaccine represented robust regulatory review and safety surveillance capabilities, for which we should be grateful. However, the messaging of this recommendation led to assumptions that the risks of continued use of Johnson & Johnson vaccine were high enough to warrant suspension in other parts of the world, where the risk-benefit calculations were quite different. Even in the U.S., willingness to receive the Johnson & Johnson vaccine plummeted with the announcement of the pause, and now stands at 19 percent, compared with 68 percent for the Pfizer vaccine.

Because the Johnson & Johnson vaccine is not critical to U.S. vaccine supply, even an extremely low risk of harm can be enough to trigger a pause in use. However, the risk-benefit calculation is very different for many other countries, where vaccines from Johnson & Johnson and/or AstraZeneca represent a significant portion of available options for the next few months. An official pause almost inevitably increases vaccine hesitancy and lowers immunization rates. The result very likely means higher rates of severe illness, hospitalization and death from COVID-19, threatening to overwhelm already-stretched health systems.

We know from behavioral economics and psychology that people are notoriously bad at estimating risk, so public leaders have a responsibility to communicate appropriately about risks and benefits in understandable ways. Well-meaning public health decisions made in wealthy countries reverberate around the world and the messaging matters. The risk of adverse events associated with the Johnson & Johnson or AstraZeneca COVID-19 vaccines is extremely small based on currently available data, far smaller than the risk of dying with COVID-19 nearly everywhere. 

The European Medicines Agency on Tuesday of last week released clear communication that recognized possible links to rare clotting events, while reiterating that benefits outweighed the risks. The South African government then announced last Thursday that it plans to resume use of the Johnson & Johnson vaccine this week — allowing its critical immunization work to continue. The U.S. followed suit on Friday, lifting its pause on the vaccine. 

If U.S. regulators and public health leaders clearly explain decisions based on contextualized risks and benefits, the U.S. can help build confidence in COVID-19 vaccines; its high-quality regulatory and safety oversight benefits the entire world. If communications are muddled or fail to recognize that other nations are watching, we could well increase vaccine hesitancy globally, shattering hopes of international vaccination campaigns and ending the pandemic. 

Andrea Taylor, MSW, is assistant director of programs at the Duke Global Health Innovation Center. She leads research on COVID-19 vaccines, partnerships, and therapeutics through the Launch and Scale Speedometer project. 

Krishna Udayakumar, MD, serves as director of the Duke Global Health Innovation Center, executive director of Innovations in Healthcare and associate director for innovation for the Duke Global Health Institute.

Michael Merson, MD, is the Wolfgang Joklik professor of Global Health and professor of Medicine at Duke University, was the founding director of the Duke Global Health Institute and the SingHealth Duke-NUS Global Health Institute, and previously served as director for the World Health Organization (WHO) programs on Diarrheal Diseases and Acute Respiratory Infections, and subsequently the WHO Global Program on AIDS.