The CDC's Replies to my Inquiries

My first questions to the CDC elicited this reply:

Your inquiry is being answered by The CDC Public Response Service.

We understand your frustration and hope to provide you with useful information. The CDC makes recommendations for the use of influenza vaccine for the prevention of influenza disease. The CDC has no facilities for the manufacture of vaccines and makes no recommendations for vaccine manufacturing. Any company willing to produce vaccine and meet the standards of the Food and Drug Administration (FDA) is free to produce, sell, or distribute vaccine. Even facilities outside of the United States are required to meet FDA standards for safety and efficacy if their vaccine is to be used in the United States.

Three organizations manufacture vaccine for use in the U.S., Aventis Pasteur, Chiron, and MedImmune. The CDC has no authority to force other private organizations to make vaccine or to make these three organizations manufacture more vaccine than they are willing.

Comprehensive information on Influenza is available from CDC's National Center for Infectious Diseases at: http://www.cdc.gov/ncidod/diseases/flu/index.htm

Thank you for contacting the CDC. We hope this has been helpful. Please feel free to reply with any additional questions to: cdcresponse@ashastd.org

Does this make you wonder who is minding the store? The flu vaccine shortage represents a basic failure of supply chain management. When someone decides to put 50 million eggs (literally!) in one basket, it is important to watch that basket. Who selected Chiron as a supplier? Who wrote the purchase order for 50 million doses? What contracts and other agreements support that purchase order? Who is managing the purchasing process? To get more information regarding these basic supplier management issues, I took the CDC up on their offer to reply with these additional specific questions:

Thanks for this E-mail, and for your invitation to submit further questions. I have a few more specific questions that I would appreciate your answering:

  1. What supplier management responsibilities have been in place to ensure an adequate supply of influenza vaccine?
  2. What prior experience does the US have in purchasing flu vaccine from Chiron?
  3. Did Chiron provide influenza vaccine to US customers last year or in any previous years? If so, in what quantities?
  4. Please describe the nature of the supplier audits that you or other US based purchasers conduct on Chiron.
  5. How often does the CDC communicate with Chiron? What is the nature of that communications? When did the CDC first suspect there may be some problem?
  6. Has Chiron undergone any significant changes or restructuring that could possibly affect their product quality or manufacturing capabilities?
  7. Please describe Chiron's quality management system.
  8. What specific failure do you believe is the cause of the present flu vaccine shortage? Please indicate the proximate cause, and each contributing factor through to the root cause.
  9. Please describe the contracts, including provisions for surveillance of manufacturing capability, maintenance of the quality management system, monitoring and acceptance of product, and any contingency or penalties that pertain between Chiron and their US based customers for influenza vaccine.

I am creating a web site, http://www.flushotfiasco.info/ to help the public better understand and cope with this problem. Your answers will be very helpful to my efforts.

Unfortunately, they replied only with this automatically generated bureaucratic boilerplate:

Your inquiry is being answered by the CDC Public Response Service.

Due to the high volume of email that we are presently receiving, offering individualized responses would create lengthy delays in response time. However, we hope to provide you with quick access to useful information and resources regarding influenza (flu):

2004-05 Flu Vaccine Shortage: Who Should Get Vaccinated: http://www.cdc.gov/flu/protect/0405shortage.htm

CDC Recommendations for Influenza Prevention: http://www.cdc.gov/flu/protect/preventing.htm

Flu facts vs. myths: http://www.cdc.gov/flu/about/flufacts.htm

Flu symptoms: http://www.cdc.gov/flu/about/disease.htm

Flu treatment: http://www.cdc.gov/flu/about/qa/treating.htm

How widespread is the flu in my state?: http://www.cdc.gov/flu/weekly/fluactivity.htm

Is it a cold or the flu?: http://www.cdc.gov/flu/about/coldflu.htm

Prescription medications that can help prevent or treat flu: http://www.cdc.gov/flu/protect/antiviral/index.htm

Tell me more about the flu shot vaccine: http://www.cdc.gov/flu/about/qa/flushot.htm

Tell me more about the nasal mist flu vaccine: http://www.cdc.gov/flu/about/qa/nasalspray.htm

Where can I go to get vaccinated?: Please contact your local health department for flu vaccine availability. You may also want to visit The American Lung Association Flu Shot Locator: http://www.findaflushot.com/lungusa/

Does the influenza vaccine contain thimerosal? : http://www.cdc.gov/flu/about/qa/thimerosal.htm , http://www.cdc.gov/nip/flu/thimerosal.htm

*Good respiratory hygiene should be encouraged, including cleaning of hands, and staying at home when symptomatic with fever and respiratory illness.

Concerns about a medical condition--either your own or that of a family member--should always be addressed to your primary care physician for advice and care appropriate to your specific medical needs.

If your question was not answered on CDC's flu website ( http://www.cdc.gov/flu/ ), we apologize. However, CDC does update the flu site in response to the types of public inquiries that are submitted. In light of the evolving nature of this situation, it is recommended that the site be consulted regularly for updates. See especially the http://www.cdc.gov/flu/whatsnew.htm page for a quick reference chart that will guide you to new or updated information.

Thank you for contacting the CDC. We hope this has been helpful. Please feel free to reply with any additional questions to: cdcresponse@ashastd.org or call the National Immunization Hotline: English (800)232-2522, Spanish (800)232-0233, TTY (800)243-7889

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