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Smallpox Virus Destruction and the Implications of a New Vaccine

MARCH 31, 2011—Baltimore, MD—The World Health Assembly is scheduled to decide in May 2011 whether the 2 known remaining stockpiles of smallpox virus are to be destroyed or retained. In preparation for this, a WHO-appointed committee undertook a comprehensive review of the status of smallpox virus research from 1999 to 2010. It concluded that, given the studies already completed on vaccines, drugs, and diagnostics, there was no reason to retain live smallpox virus except to satisfy restrictive regulatory requirements, which should, in any case, be modified.

The committee asked researchers and regulators to define alternative models for testing the new vaccines and drugs for smallpox. Licensing such drugs has posed difficult problems. No less important are the projected costs of these products – the costs involved in developing the products, manufacturing and testing them, and stockpiling and storing new products.

In a commentary published online ahead of print in the journal Biosecurity and Bioterrorism, noted smallpox expert Dr. D. A. Henderson outlines the approximate costs of a new vaccine. He also looks at the incremental contribution that a newly developed vaccine might make in terms of public health security.

Henderson’s estimates of the probable costs for developing, manufacturing, and stockpiling a new vaccine look like this:

  • Development costs for a new vaccine: $250 million to $1 billion
  • Construction costs for a new production facility: about $500 to $750 million
  • Costs for buying 50 million doses of either of 2 already licensed vaccines: $150 million
  • Costs of 50 million doses to create a stockpile of a new vaccine: at least $2.5 billion 

Henderson concludes: “With 2 highly protective vaccines available and the completion of work on 2 antiviral drugs virtually completed, is it warranted to continue to invest heavily in new vaccines and additional antiviral drugs that we hope and expect will never have to be deployed? Might it not be better to give priority to assuring that we have an adequate emergency reserve of smallpox vaccine and antiviral drugs that we know will protect against smallpox, and [to use available resources] in strengthening the international and national response capabilities for surveillance, containment, and laboratory capabilities? The retention of the existing stocks of live smallpox virus are not required for this agenda.”

The commentary, titled “Smallpox Virus Destruction and the Implications of a New Vaccine,” appears online ahead of print in the June 2011 issue of Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, a peer-reviewed journal published by Mary Ann Liebert, Inc. (www.liebertpub.com). The article is available free online at https://www.liebertpub.com/doi/10.1089/bsp.2011.0011       

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Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, a quarterly peer-reviewed journal, is published by Mary Ann Liebert, Inc. It provides an international forum for debate and exploration of the many key strategic, scientific, and operational issues posed by biological weapons and bioterrorism.

The Center for Biosecurity is an independent, nonprofit organization of the University of Pittsburgh Medical Center (UPMC) whose mission is to strengthen national security by reducing the risks posed by biological attacks, epidemics, and other destabilizing events, and to improve the nation’s resilience in the face of such events.

 

 

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