Will Little-known Federal Advisory Panel Deprive Infants of Meningitis Vaccine?

Cross-posted by Forbes.com 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).

4 thoughts on “Will Little-known Federal Advisory Panel Deprive Infants of Meningitis Vaccine?

  1. First, before any vaccine should be recommended for mass use, that vaccination program should be projected to be cost-effective.

    Second, in general, the ACIP’s is overly generous in approving vaccines for mass use because: a) its decisions are based on vendor-supplied data, b) presume that the benefits claimed will be realized by those inoculated with the vaccine, and c) wrongly IGNORE the costs of the adverse reactions in computing the costs of the vaccination program versus the “projected” savings.

    Third, though the criterion should be medical cost-effectiveness, the ACIP, when it does consider the issue of cost-effectiveness currently uses the more-industry-favorable societal cost-effectiveness, which it should not do.

    Based on the preceding and considering the very real costs of harm from the existing uses of the vaccines for meningococcal meningitis and the failure of all of this vaccine’s manufacturers to fully disclose the composition of these vaccines:
    1. the mass use of this vaccine in infants should be rejected and
    2. the existing recommendations for the mass use in older children and young adults should also be withdrawn because the current mass-vaccination programs are clearly NOT medically cost effective when all costs, including the projected number of individuals who are “permanently” maimed or die as an apparent result of their being vaccinated with the current vaccines for Neisseria meningitidis — the protection provided: a) now is claimed to last no more than 5 years, b) the vaccines only cover 4 of the 9 strains of disease known to cause clinical meningitis and death in humans, and c) the percentage of those vaccinated who are truly protected in an exposure setting is clearly less than the 85% efficacy based on the vaccine maker’s measurement of antibody titer.

    Overall, this article appears to be industry-favorable lobbying in an attempt to ignore the reality that approving a mass vaccination program for infants as the vaccine makers want to increase their customer base and profits is not only NOT cost-effective but also probably would harm more babies than it would protect.

    Clinically, “meningococcal meningitis” is a rare disease — less than 1,000 cases annually in a population of 300+ million and the disease trend has been trending downward from before any vaccine was introduced and the current vaccines are apparently NOT very in-use effective and, with the reduction in claimed protection window from 10 years to 5 years and the recommendation of a booster dose, NOT at all cost-effective for mass use.

    Finally, since the ACIP’s membership is composed of “qualified” pro-vaccine activists including those who consult with the vaccine firms and are NOT “federal health officials” per se, and these members routinely have to be granted conflict-of-interest waivers, this writer’s: “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)”, is false Orwellian doublespeak.

    What has done more to undermine the achievements of the “public health establishment” is the reality that this “establishment” has repeatedly been found to puts its profits above “public health”!

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