December 13, 2004
The World Health Organization (WHO) posted on their website last week the proposal by their Ad Hoc Committee on Orthopoxvirus infections to form a WHO Smallpox Vaccine Bank for emergency use, defined as at least one confirmed case of smallpox anywhere in the world.
This Smallpox Vaccine Bank would have three (3) components: (1) a stockpile of vaccine kept in Geneva, (2) a stockpile of vaccine kept by WHO Member States but pledged to be given to WHO for use in the event of an outbreak, and (3) identification of at least two manufacturing sites capable of significant sustained smallpox vaccine production.
Of the multiple recommendations made by the committee, one is selected here from each of the three components to illustrate quantitative aspects of the vaccine stockpile:
(1) With regard to the WHO stockpile in Geneva: “The volume of the Geneva stockpile should be at least 5 million doses either of lymph-derived or cell-culture derived vaccines.”
(2) With regard to the WHO pledged stockpile kept by donating nations: “The size of the pledged stockpile should be at least that available to WHO at the end of the eradication programme (200 million undiluted doses). Pledged stocks will remain under the control of the donor Member States...” WHO might ask Member States to consider donating 10% or more of their national smallpox vaccine stockpile to WHO. Also, “legal advice would be obtained on the liability issues associated with, and any disclaimers that might be needed for, the distribution of vaccine from the WHO Smallpox Vaccine Bank”.
(3) With regard to the third component of the WHO stockpile: “WHO should review the global manufacturing capacity for smallpox vaccine and it should work with the Member States to ensure that there are at least two manufacturing sites capable of producing 20 million doses per month for a prolonged period of at least 10 years.”
The proposal of this Committee, which will go to the WHO Secretariat for incorporation into a paper to be presented to the WHO Executive Board serves to recognize the continuing threat of smallpox as a bioterrorism weapon of mass destruction, an act that many would consider a “crime against humanity”.
In addition, this WHO proposal also recognizes the critical need to have ‘Smallpox Vaccine For All-in-Need’ and not focus vaccine stockpiles primarily on individual nations, including the “USA, given the near-certainty of global spread of smallpox if the disease is reintroduced into the unvaccinated and therefore highly-vulnerable human species.”
Daniel R. Lucey, MD, MPH
Director, Center for Biological Counterterrorism and Emerging Diseases