Is it Time for a Global Vaccine Injury Compensation System?

While vaccines offer safe and effective protection from disease and infection, adverse reactions ranging from hives to death can occur on very rare occasions, according to an viewpoint published on February 7, 2017 in the Journal of the American Medical Association (JAMA).

Some countries have adopted no-fault compensation systems for serious vaccine side effects. However, a vaccine injury compensation system administered at the global or regional level would be more helpful in addressing these concerns, said the article’s lead author, Sam F. Halabi, JD, MPhil, a scholar at Georgetown University’s O’Neill Institute for National and Global Health Law and an associate professor at the University of Missouri School of Law in Columbia.

Such a compensation system would be especially beneficial during infectious disease emergencies. In preparation for a potential pandemic, “we need to have a plan in place for vaccine side effects; especially [for] those [vaccines] developed on shortened timelines,” Halabi told Contagion^®.

Routine immunization programs throughout the world deliver more than 30,000 vaccine doses every second, estimates indicate, preventing an estimated 2 million to 3 million deaths annually. Vaccine injuries are exceedingly rare. For instance, the injury rate for the tetanus vaccine is less than one per 10 million doses. The injury rate for the influenza vaccine is one-to-two per 10 million, the JAMA report noted.

“Yet the specter of vaccine injury plays a central role in vaccine access and will continue to do so as vaccine technologies evolve,” the authors wrote. “The H1N1, Ebola, and Zika public health emergencies illustrate the relationship between vaccine access and vaccine injury.”

As laboratories across the globe race to develop a vaccine for the Zika virus, the authors contended that even if a vaccine were available today, many of the world’s poorest people would be unable to receive it due to political and economic concerns about adverse reactions.

“An H1N1 vaccine was developed within four months, but it did not reach poor countries for another five months because of disagreements about accepting liability for potential side effects,” Halabi told Contagion^®. “If a plan like ours had been in place, there would have been either no delay or a reduced delay.” Similar liability concerns have been raised with the Ebola and Zika viruses, he added.

Who pays for the injured can become a source of disagreement. It can escalate to a life-and-death situation, especially when countries are battling a public health crisis.

To address vaccine injury, the authors mentioned three approaches: those suffering adverse events may bear their own costs; they may seek compensation through litigation against private sector actors, mainly manufacturers; or, they may receive remuneration from public-supported systems funded in whole or in part by private sector contributions.

A global vaccine-injury compensation system would bring economic certainty to this vital aspect of the public health system while instilling the trust needed for vaccine acceptance in recipient communities, particularly in emergency contexts, the authors wrote.

“Such a system would address barriers to vaccine manufacturers’ participation as well as perceptions that fuel vaccine hesitancy in low-resource countries,” they concluded.

Susan Kreimer, MS, is a medical journalist with more than two decades of experience. Her coverage has informed consumers, physicians, nurses and health system executives. Ms. Kreimer holds a master’s degree in journalism from Columbia University and lives in New York City.