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• The total number of shots goes up per visit unless GlaxoSmithKline vaccines are preferentially used. Hib-MenCY-TT was developed and is licensed by GlaxoSmithKline, a world leader in pediatric vaccines, and they are building a portfolio of vaccines that can fit together well. There is nothing wrong with that – it is good marketing. Sanofi Pasteur Vaccines is doing the same thing and, as more products are forthcoming from Pfizer Vaccines, Novartis Vaccines, and others, we can expect the same strategy. However, the CDC, AAP, and AAFP do not want to endorse products that limit choices and/or provide any single company with a competitive advantage. So, to endorse Hib-MenCY-TT that clearly fits best with only GlaxoSmithKline vaccine products may be an unspoken concern.
• The National Immunization Program cannot afford it. Going back to the presentation to ACIP at the CDC in October 2011, a key aspect was the cost of vaccination calculated against cases prevented and lives saved. The calculation for Quality-Adjusted Life Year (QALY) saved for a two-dose schedule among adolescents came out to $157,000/case. For the infant vaccination, the numbers were pretty staggering at $3.6 million/case, based on the current incidence of meningococcal infections in the United States (see sidebar). Even if the incidence of meningococcal infections were currently as high as they were back in 1997-1999, the cost would be $0.5 million/case. For those thinking about the option of toddler vaccination with the quadrivalent meningococcal conjugate vaccine (Menactra), the calculations for QALYs concluded that such a strategy prevented half as many cases at half the cost.
So where do we go from here? The lack of an endorsement by ACIP/AAP/AAFP for universal use* normally means that the vaccine will not be available within the Vaccines for Children free program, and it will not be covered by commercial health insurance plans except for the specific indications endorsed by the recommending bodies.* So these are huge barriers to use. Nevertheless, it is a licensed vaccine and it is safe and effective, just not perfect and not cost-effective for widespread public use at government expense. How much is a child’s life worth? If it is your child, then the life is priceless. But in public health there are limits to what can be afforded. We will see more of these types of issues in the future. Another unspoken concern of the ACIP/AAP/AAFP is that a two-tiered vaccine access situation develops. In other words, for those who can afford to pay, Hib-MenCY-TT is available and, if they can pay for it out-of-pocket, then they can buy it to protect their child.
The following are cost-effectiveness analysis conclusions that were presented to the CDC:
• Vaccinating infants or toddlers with meningococcal vaccine has a high cost per case prevented – even at a low vaccine price.
• Cost estimates are much higher than prior analyses because of declining incidence and shorter duration of protection.
• Infant vaccination prevents twice as many cases as toddler vaccination but at twice the cost – cost per QALY saved is similar for both strategies.
Dr. Pichichero, a specialist in pediatric infectious diseases, is director of the Rochester (N.Y.) General Hospital Research Institute. He is also a pediatrician at Legacy Pediatrics in Rochester. Dr. Pichichero disclosed that in the past 3 years, he has served as a consultant to Sanofi Pasteur, Pfizer, Novartis, and Crucell for their vaccines currently licensed and in development. Dr. Pichichero also disclosed that in the past 3 years, his academic institution has received research grants to support vaccine work from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Novartis, and Crucell, including studies involving Hib-MenCY-TT produced by GlaxoSmithKline and Quadrivalent meningococcal vaccine by Sanofi Pasteur and Novartis.
* This article was updated on 10/26/12.