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© 2006 American Academy of Pediatrics
NEWS AND FEATURES |
The shortage of quadrivalent meningococcal polysaccharide-protein conjugate vaccine (MCV4, Menactra) has prompted questions from pediatricians regarding how to obtain vaccine, how long supplies will be limited and how to receive payment for the full cost of the vaccine.
On May 19, the Centers for Disease Control and Prevention (CDC) recommended deferring vaccination of 11- to 12-year-olds with MCV4 until further notice. The CDC also outlined high-risk groups that should continue to receive MCV4 during shortages (www.cdc.gov/mmwr/preview/mmwrhtml/mm55d520a1.htm).
Manufacturer sanofi pasteur anticipates that MCV4 demand will outpace supply at least through the summer. Currently, providers can get up to 20 doses per month.
Following are answers from a sanofi pasteur representative to frequently asked questions regarding the MCV4 shortage.
Q: Why is there a shortage of MCV4?
A: Sanofi pasteur has met its capacity for production of MCV4 for the last few years. In 2005, the Academy and CDC recommended routine MCV4 immunization of 11- to 12-year-olds, 15-year-olds (at high school entry) and entering college freshmen who would be living in dormitories. The number of doses needed to fulfill these new recommendations is higher than the amount sanofi pasteur is able to produce.
In addition, the uptake of MCV4 has been higher than expected, thanks to the hard work of pediatricians. Finally, claims data show that some physicians are immunizing 11- to 18-year-olds rather than just the recommended age groups in an effort to "catch-up." This may be adding slightly to the problem.
To meet the high demand, sanofi pasteur anticipates opening a new vaccine manufacturing facility in 2008 to produce MCV4.
Q: Is there a problem with distributors?
A: Sanofi pasteur has not sold MCV4 to wholesalers or distributors for almost a year, and the percentage of doses it did sell through that channel was very small. All advertising for MCV4 also has been stopped.
Q: I need more than 20 doses for my office. How can I get them?
A: Due to higher than expected demand, sanofi pasteur has been limiting MCV4 vaccine orders since July 2005 to help ensure equitable distribution of vaccine to public and private sector providers. However, for customers who require more than 20 doses per month (e.g., offices with a large number of providers), the company has implemented a process by which requests for additional doses can be evaluated and shipped as appropriate. Either work with your sanofi pasteur representative to submit the request or ask for an exception when you call to place your order. The exception process is not available online.
For public health providers, sanofi pasteur is working with the CDC to determine states' individual needs, including purchases under the Vaccines for Children program.
Q: I am in a VFC universal purchase state that does not offer MCV4. What can I do?
A: Data indicate that at least 46 of 56 Vaccines for Children programs have placed orders for MCV4. If a VFC program has not yet ordered, the trend has been to wait until the supply is adequate to cover everyone in the state. MCV4 is available only through private payers in those states.
Q: I am vaccinating patients with MCV4 but still not getting paid for the full cost of the vaccine. Can sanofi pasteur help?
A: When sanofi pasteur is notified of such a situation, it will work with payers to verify the cost of the vaccine and request payment for the full cost.
The Academy also is urging pediatricians to check with families to verify that the vaccine is a covered benefit before administering it to 11- to 12-year-olds in a high-risk category. Because managed care organizations follow CDC recommendations, these payers may alter their benefits coverage as a result of the interim recommendation to defer MCV4 for the 11- to 12-year-old age group. If payers do not cover the immunization, the family is responsible for payment. Pediatricians are advised to have these families sign a waiver. Sample waiver forms can be downloaded from the AAP Member Center by clicking on the Private Payer Advocacy link on the right and then on Waivers: The Basics for the Pediatric Office.
Questions should be directed to sanofi pasteur at 1-800-Vaccine (800-822-2463).
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