Recalibrating Vaccination Laws

Abstract

The United States is in the midst of a vaccine crisis. States utilize their police power to establish vaccine mandates, but the federal government — via the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”) — maintains responsibility for incentivizing vaccine innovation, ensuring a stable vaccine market, and affording compensation for vaccine-related injuries. Although the Vaccine Act may have been the cure for the vaccine woes of the 1980s, the law has failed to keep pace with technological advancements and evolving public policy concerns. As was the case during the 1980s, today’s vaccine market is highly consolidated and the public depends on one or two manufacturers for most childhood vaccines. This has led to vaccine shortages and a lack of competition in vaccine design. Rather than incentivizing timely adjustments to vaccine formulas, the Vaccine Act’s broad legal immunities for vaccine manufacturers have created a regulatory vacuum whereby manufacturers are not obligated to incorporate scientific developments into marketed vaccines. Furthermore, the Act’s complex compensation mechanism has failed to resolve vaccine-injury claims fairly and expeditiously. Meanwhile, declining public trust in government and industry fuels vaccine hesitancy and creates population health challenges for public health officials.

Recalibrating vaccination laws can help remedy these imbalances. While the Vaccine Act may not be a primary cause of vaccine hesitancy, amendments to the law can be part of the solution. Grounded in a comprehensive analysis of the historical context preceding the enactment of the Vaccine Act, this Article details how statutory levers can address modern-day concerns in vaccine policy and provides draft legislation that furthers the Vaccine Act’s public health, compensation, and market stabilization goals. Using law as a means of furthering the public health and building public trust in vaccines, the proposals focus on increasing safety and efficacy research, adjusting preemption provisions, and expanding the safety net for vaccine-related injuries.

Keywords: Vaccines, Bioethics, Health Policy, Health Law