‘Precision medicine’ should help inform vaccine policy

John Kirlin says we must give high priority in public funding for science to improve understanding of the effectiveness and side effects of vaccines on individuals.
John Kirlin says we must give high priority in public funding for science to improve understanding of the effectiveness and side effects of vaccines on individuals. Associated Press file

Gov. Jerry Brown announced the “California Initiative to Advance Precision Medicine” on April 14, less than a week after the Senate Health Committee voted 6-2 to pass Senate Bill 277, which narrows exemptions from vaccination requirements for admission to K-12 schools. Neither advocates of precision medicine nor those contesting the future of vaccine policy have confronted the inconsistencies in these two policies or the promise that precision medicine offers to improve vaccine use.

As noted by the governor, precision medicine seeks to “understand why people who seem to have the same disease often respond differently to treatments.” Similar advances that reveal differences among individuals are being made in scientific understanding of genetic roots of diseases and roles of the human microbiome in maintaining health and immune systems. In contrast, vaccine policies presume to achieve the same effects on virtually all. Important challenges to vaccine policies arise from broad developments in science, even more than from specific bad reports or allegations of systemic negative side effects.

My expertise lies not in medicine, but in designing public policy processes where addressing uncertainty and conflict in values is critical to effective policies. The emerging “personalized” medicine increases uncertainty – “what does science know about the effects of vaccine on individuals?” It also increases conflict between those focused on the large benefits of vaccines to society and most individuals, and those focused on evidence of negative side effects. In time, scientific advances may target vaccines to individuals, reducing both uncertainty and conflict, but not soon.

Experience with policy choices characterized by significant uncertainty and high conflict suggests three approaches – research, cautious exercise of regulatory powers and flexibility – are worth consideration.

First, give high priority in public funding for science to improve understanding of the effectiveness and side effects of vaccines on individuals. This action acknowledges uncertainty regarding vaccine effects, continues science as the basis for judgments regarding vaccine policies and commits government to improving scientific understanding in this critical area. The governor’s initiative included a modest $3 million for startup which could be targeted in this area and increased over time.

Second, cautiously define the minimum vaccination requirements for K-12 enrollment. The expansive “any other disease deemed appropriate by the department” of SB 277 violates this principle. Additionally, a review of current vaccination recommendations which predate the recent explosions of knowledge of genetics and the human microbiome or use of big-data analytics is prudent.

While eight vaccines were required in the 1980s, combinations could result in only five shots by age 2 and likely about 10 shots total by age 12. Two additional vaccines have since been required (chicken pox and Hepatitis B), but the number of shots has increased to more than 20 by age 2 and a total of 40 by age 12 under the Centers for Disease Control and Prevention recommendations.

This four-fold expansion of shots recommended occurred incrementally and now requires thorough assessment of cumulative effects. To usefully inform policy-making, this assessment must include scientists from the relevant emerging fields, must be transparent in its work, must be independent in establishing findings and offering recommendations, and should be completed in a year or less.

Third, maintain limited pathways for parents to opt out of vaccination, with graduated consequences, but continued opportunities for successful education of children. The current legislative processes on SB 277 are addressing this issue. Recognizing the relevance of personalized medical science to vaccination policies and commitment to the first two actions identified above could inform these decisions and possibly reduce conflict.

Vaccines make huge contributions to individuals and to communities, and undoubtedly will continue to be required. For success, policy processes must embrace the uncertainties created by emerging personalized medicine. Vaccination policies should be informed by science but cannot be made just by scientists or in a bureau’s regulatory processes until the emerging understanding of individual variations is more advanced.

John Kirlin has analyzed, taught and written about public policies, especially in California, for more than four decades. He was founding editor of “California Policy Choices” and was executive director of Delta Vision.