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In the past, this committee has routinely recommended vaccines approved by the FDA, basing its decisions mainly on public health needs. However, in recent years, the ACIP has shifted its focus from the safety, efficacy and impact of life-saving immunizations to unclear cost-effectiveness evaluations of these medicines.

The ACIP can choose to issue a “routine/universal” or a “permissive” recommendation.  A “routine” recommendation puts that vaccine on the standard childhood immunization schedule that all health care workers follow.  A “permissive” recommendation does not.  This system has taught health care providers to regard routine vaccines as the truly “important” immunizations while others are optional. 

The result?  The human papillomavirus (HPV) vaccine for boys, with a permissive recommendation, saw less than one percent of young men vaccinated a year after its approval; today, another year later, that rate is less than two percent.  Compare this to the rotavirus vaccine, an immunization that received a routine recommendation, which was administered and immunized 43 percent of children in its first two years of ACIP recommendation.

The ACIP’s decision-making process is now in danger of unnecessarily putting infants at risk of bacterial meningitis.  A vaccine to protect against this disease is currently recommended for ages 11- 12 years with a booster shot around age 15.  What few people realize, however, is that infants are also at significant risk for this strain of bacterial meningitis and can be protected through vaccination.  Yet because of the relatively higher cost of this vaccine, the ACIP may not approve it or endorse its universal use.

In other agencies such as the Centers for Medicare and Medicaid Services (CMS), financial assessments are divorced from policy decisions to avoid conflicts of interest.  The ACIP, however, determines who should receive a vaccine and whether in the case of children it should be included in the Vaccines for Children program. This latter decision triggers coverage by private payers. 

Because CMS is not encumbered by financial decisions, it has consistently approved important new treatments simply on the basis of their safety and efficacy.  If the product under discussion was actually a treatment for meningitis, rather than a vaccine, would we be having the same debate?  Or would we be approving a medicine ten times the cost of a preventative immunization?

In the past, routinely recommending vaccinations has not been a difficult decision because there was consensus among the majority of academics, scientists and public health officials that vaccines save money and a broader coverage is necessary to achieve their full impact.  Today, this perception of the “value of vaccines” has shifted in response to growing costs of using advanced technology that allow us to tackle more difficult, and often more rare, diseases.  Even these increased costs are still reasonable compared to many other public health interventions, such as home smoke detector installations and asbestos removal.

The ACIP’s limited scope in public health – solely focused on the evaluation of immunizations – makes it difficult for members to make those comparisons to health interventions that are not vaccine related.  A broader group such as CMS would be better able to see immunizations’ high cost-effectiveness compared to the cost-effectiveness of other interventions, which cost the government and society billions of dollars each year.  To further complicate the issue, standard cost evaluations do not apply well to vaccinations as considerations such as herd immunity, or the ability to protect an entire community by not vaccinating everyone, is not taken into account.

The uncertainty of the approval process is creating an environment in which vaccine developers are less likely to invest in the research of vaccines to prevent serious diseases that may have lower incidences or burdens of disease, but still have debilitating and/or deadly effects on those inflicted.
Immunizations will never be the next blockbuster drugs of pharmaceutical companies; thus, they are often the first research programs cut if their approvals seem uncertain.  Unless we can create a transparent process, it is doubtful we will see many new vaccines, if any, in the near future.

In a country determined to promote prevention and wellness, a leading form of prevention has been neglected and left to a committee that is struggling under an outdated mandate to do the right thing for public health.  It is high time we re-examined the United States’ vaccine approval process and separate financial decisions from public health considerations.  Unless we move quickly to remedy this situation, we will deprive future generations of longer, healthier lives.

ADEL A.F. MAHMOUD, M.D., Ph.D. holds joint appointments at Princeton University as senior molecular biologist at the Woodrow Wilson School of Public and International Affairs and professor in the Department of Molecular Biology.  He is the former president of Merck Vaccines.