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See Inside October 2009

Swine Flu Vaccine--Too Little, Too Late

Long-standing liability issues leave us unprepared for a pandemic



Matt Collins

As health care workers in the U.S. gear up for the flu season, they facea paradox: on the one hand, they will have too little vaccine against the novel influenza A (H1N1) strain to protect the entire population; on the other, some people will resist the shots that are offered to them. Sadly, both problems can be traced, at least in part, to the last time “swine flu” loomed. The 1976 national vaccination campaign against a pandemic that never materialized left the public with lingering doubts about whether the inoculations harmed some recipients and spawned lawsuits that cost the federal government nearly $100 million.

Since that episode, both public mistrust of vaccines and vaccine makers’ mistrust of a litigious public have only grown—hampering the nation’s ability to respond to the current, very real, pandemic. The Centers for Disease Control and Prevention expect the virus to sicken up to a third of the population this fall. But the nation will have barely enough vaccine for a third of its residents because methods used to make U.S. flu vaccines have changed little in half a century. Health officials decided early in the summer to stick with slow, egg-based production techniques and to eschew dose-sparing additives that might have tripled the vaccine supply.

In “Boosting Vaccine Power,” Nathalie Garçon and Michel Goldman describe a new generation of ad­juvants—immune-stimulating vaccine ingredients—that take advantage of scientific advances in understanding immune cell interactions. A few years ago the clinical trial of an experimental pandemic vaccine against bird flu containing one of these new adjuvants provided protection using less than a third of the usual amount of virus antigen in seasonal flu vaccines and produced minimal side effects. Another novel adjuvant has been approved for use in European seasonal flu vaccines for more than a decade.

Yet the U.S. does not permit use of the new adjuvants in vaccines, except in emergencies declared by the Food and Drug Administration (which is hardly likely to inspire public confidence). Even procuring a pandemic vaccine using traditional methods required the government to grant vaccine makers immunity from lawsuits and instead take the liability onto itself, as it did in 1976. Without such protections, vaccine makers were unwilling to enter the market. Fear of litigation had already driven most of them to leave the business. In the 1970s 25 companies made vaccines of all kinds. By 2004 only five remained.

In 2002 the SAFETY Act also granted immunity to potential makers of antibioterror vaccines and drugs. But the expedient of blanket immunity in an emergency is hardly a long-term solution to the crisis in vaccine development. In existing legislation, however, we have a model for a mechanism that would give reasonable compensation to victims of unforeseeable vaccine injuries while also shielding manufacturers from unpredictable legal liability for vaccines that work as intended. In 1986, recognizing the possibility that fundamental childhood vaccines could become unavailable if no one were willing to make them, Congress passed the National Childhood Vaccine Injury Compensation Act. It established a no-fault court to handle injury claims, with ceilings on potential damages. The settlements are financed by a tax on every vaccine dose. This system could be extended to all vaccines.

In 1985 an Institute of Medicine report, “Vaccine Supply and Innovation,” advanced several other options for safeguarding vaccine research and thereby vaccine safety and supplies. Few viable alternatives have been offered since. It is impossible to know what vaccine technologies might have been available to meet the challenge of the influenza pandemic of 2009 had vaccine science not been bogged down by liability concerns for so long. But almost certainly one reason the U.S. has too little vaccine going into the fall is that attention to the decades-old issue of vaccine liability has been too late in coming. As policy makers tackle health care reform in the coming months, we call on them to address the problem of vaccine liability—both to restore public confidence in this critical health intervention and to ensure that the best and safest vaccine technologies are available before the next pandemic.

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