Cross-posted by at On the DocketFor meningitis sufferers and patient advocates, things were looking up just a few years ago. Doctors and public health programs were successfully deterring the deadly and disfiguring disease in children and adults with FDA-approved vaccines, while public health officials were encouraging drug companies to research and develop vaccines for infants. In 2008, meningococcal disease rates were higher for infants than for kids ages 2-10. Since 2009, however, a cloud has been cast over crucial infant vaccinations by a little-known vaccine advisory group within the Centers for Disease Control (CDC). Disturbingly, its concerns center not around the vaccine’s safety, but around its cost and “cost-effectiveness.”

What Is ACIP? The Secretary of Health and Human Services selects the fifteen members of this CDC-based group –the Advisory Committee on Immunization Practices (ACIP). ACIP members are full-time clinicians, academics, and state public health officials. They review new vaccines and new uses of existing vaccines and make recommendations to the CDC on which vaccines should be routinely administered to the public, as well as the number and intervals of dosing. These recommendations impact not only billions of dollars in federal purchases of vaccines, but are also unfailingly followed by pediatricians and other doctors. Further, under § 2708 of the Affordable Care Act of 2010, private health insurers must cover ACIP-recommended immunizations.

ACIP’s Preemptive Cost Concerns.  Three pharmaceutical manufacturers produce FDA-approved vaccines for meningococcal disease. They have been researching and testing the use of those vaccines for children under two-years old. Last month, FDA approved infant use for one vaccine, Menactra, with approval of others anticipated this year. Beginning in 2009, ACIP began evaluating an infant meningitis vaccine and sent clear signals that it was inclined not to recommend routine use for children under two. ACIP had never before sent such a strongly preemptive message on a vaccine’s use before FDA had approved it.

The summary report from a February 2010 ACIP meeting reveals that ACIP members felt the cost of immunizing infants outweighed any benefits. Their application of a utilitarian, one-size-fits-all “value of life” measuring tool – quality-adjusted life year (QALY) – along with the low number of infant meningitis cases at the time and an estimate that 41% of infant meningitis cases could be prevented led members to opine (without a formal vote) that the vaccine just wasn’t worth it.

One industry representative at the meeting remarked that ACIP took a similarly myopic view of meningitis vaccines for older children until during the public comment time at an ACIP meeting, “parents brought their children in with the amputations, scarring, etc.  That changed [members’] attitudes.” Apparently, the pleas of parents at the February 2010 meeting, which included one whose son contracted the disease at seven months leading to amputation of both arms and legs, hasn’t resonated similarly with these ACIP members.

A Dangerous Public Health Precedent. ACIP is scheduled to provide its final recommendation on infant meningococcal disease vaccines this October. The committee and CDC must be feeling a lot of heat on their evaluations to this point, because CDC is, we have heard, holding a “public” meeting today on meningococcal immunization featuring stakeholders in the debate and others who were able to wrangle invitations to be “observers.” The agency is so tightly controlling the gathering that it never publicly announced this public meeting; there is nothing on the CDC or ACIP websites and our determined, interested-member-of-the-public inquiries have come up empty. Hopefully, some of the participants will explain to ACIP and CDC why the path they are taking on infant meningitis is a deeply perilous one for public health.

First, the enormous impact its deliberations and recommendations have on public health must be strongly impressed upon ACIP. Even though there is now a meningitis vaccine judged by FDA to be safe and effective for infants, no pediatrician is going to use it, and no health insurer is going to cover its use, until ACIP acts. Let’s hope at tomorrow’s meeting, concerned parents will demand answers from ACIP members and CDC officials on why their infant cannot be vaccinated even though FDA says it’s safe to do so.

Second, serious questions must be asked of the dramatically heightened role of cost effectiveness in ACIP’s deliberations. Are the fifteen clinicians and academics on ACIP equipped to make decisions based on complex health economics? Can a measuring tool like QALY properly be used in an area like infant meningitis, where cases are rare and econometric inputs such as future lost earnings can’t be realistically pegged? Are the millions in health care costs for infant survivors of the condition factored into the equation? Finally, what is motivating this intense focus on cost? That question might be answered by viewing a presentation to ACIP by CDC Director Thomas Frieden, who made his opinion very clear that vaccines are getting too expensive.

Third and finally, ACIP and CDC need to understand how their recent actions could severely undermine vaccine development and production in America. Vaccine manufacturing is already fraught with risk. Vaccines are an inherently unstable drug due to the complexity of biologics, resulting in far more failures than successes in development. Bringing one vaccine to market costs upwards of $1 billion. Manufacturing plants, which cost up to $300 million, must meet exacting FDA standards and pass scores of inspections. The return on such massive investments is small compared to other drugs due to actual and virtual government price controls and the inherent limited time and amount of vaccines’ use. Vaccine makers have also had to endure decades of finance-draining, baseless litigation.

After enduring all these risks, and receiving FDA approval, vaccine makers can still have the rug pulled out from under them in the proverbial eleventh hour by ACIP and its cost-effectiveness calculations.  ACIP has never rejected use of an FDA-approved vaccine in its history.  If an infant use for meningococcal vaccines becomes the first, what kind of message will that send to vaccine makers?

The Bottom Line. Vaccination against diseases that used to kill millions is one of human kind’s greatest technological achievements, a success in which public health organizations and their leaders have played a major role. It would be a deeply unfortunate irony if we allowed a small number of federal health officials to undermine all that has been achieved by the larger public health establishment (along with private entrepreneurship and enterprise).