South-North Development Monitor (SUNS) #7150,16 May 2011
Health: Call to destroy remaining smallpox virus stocks
Kuala Lumpur, 13 May (Lim Li Ching) — As the 64th World Health Assembly (WHA) opens on 16 May, global interest is turning again to the issue of destruction of smallpox (variola) virus stocks. More than 30 years after smallpox was eradicated in the wild, live virus stocks are still held in two World Health Organization (WHO) repositories in the United States and Russia.
Forty-one civil society organizations have signed an open letter calling on WHA delegates to unequivocally terminate research with smallpox virus and to fix a prompt and irrevocable date for the destruction of the virus stocks. Their call is echoed by many in the scientific community, particularly those who were involved in eradicating smallpox from the wild.
In February 2011, an editorial in the journal Vaccine asked, ‘"Why not destroy the remaining smallpox virus stocks?" The editorial was written by J. Michael Lane, former head of the Centers for Disease Control and Prevention (CDC) smallpox eradication programme and Gregory A. Poland, Editor-in-Chief of Vaccine.
[The CDC is the WHO repository for smallpox stocks in the United States. The other WHO repository is the Russian State Centre for Research on Virology and Biotechnology (Vector), Novosibirsk, Russia.]
The Vaccine editorial highlighted that the little research that is necessary does not require the live smallpox virus and can be done using alternative models, which "suggest that retention of the live viral stocks is unnecessary, and represents an unnecessary risk to mankind."
It concluded, "It is time to destroy our remaining smallpox virus stocks, call upon the rest of the world to do the same, and make possession of the virus an international crime against humanity. We find no evidence to compel us to do otherwise."
The 64th WHA of the World Health Organization meets on 16-24 May, where it is meant to consider the results of a major review of smallpox research. The outcome of the major review found no compelling scientific or public health reason to continue to retain the virus. This provides the 64th WHA with clear justification to terminate research involving live smallpox virus and to schedule the prompt destruction of remaining stocks.
Nearly a quarter century ago, in 1986, the WHO Committee on Orthopoxvirus Infections first recommended that the viruses be destroyed, so that the risk of a future outbreak would be radically reduced. This recommendation was followed by more recommendations for destruction, with the WHO Ad Hoc Committee on Orthopoxvirus Infections in 1990 suggesting a destruction date of 31 December 1993; and again in 1994, recommending destruction on 30 June 1995.
These recommendations were taken up by the global health community, whereby Resolution WHA49.10 (1996) recommended that remaining stocks be destroyed on 30 June 1999.
Following refusal by the United States and Russia to do so, Resolution WHA52.10 (1999) authorized temporary retention up to, but not later than, 2002. Temporary retention was authorized only for research essential to global public health, namely, in sequencing, diagnostics, vaccines and antivirals, and development of an animal model that would assist in these efforts.
Come 2002, there were still objections from the United States and Russia to destroying the stocks. Hence, WHA Resolution 55.15 (2002) authorized further, temporary, retention of existing stocks, with no date for destruction set. Following dangerous proposals by the United States to genetically engineer smallpox, which were eventually thwarted, the WHA stepped up its scrutiny over the smallpox research programme, a process that culminated in Resolution WHA 60.1 (2007).
That Resolution called for a major review in 2010: of the research undertaken, underway and plans and requirements for further essential research for global public health purposes, so that the 64th WHA may reach global consensus on the timing of destruction of existing stocks.
The major review consists of two parts: a scientific review of smallpox research conducted from 1999-2010 and a public health assessment. The scientific review mainly represents the views of virologists who work with smallpox and related orthopoxviruses. It is authored or co-authored by United States and/or Russian government scientists employed by the ministries that host the WHO Repositories.
More importantly, the public health review paper offers a review of research undertaken (as documented in the scientific review paper) and an assessment of whether additional research using live smallpox virus is necessary from a global public health perspective. It was prepared by the Advisory Group of Independent Experts to review the smallpox research program (AGIES), members of which were appointed by the WHO Director-General.
The AGIES did not include representatives of the WHO repositories in Russia and the United States, or the respective ministries that manage them. It was also notably more geographically balanced than the scientific paper authorship, including experts from all WHO regions.
Thus, while the scientific review paper provides important data from persons working inside the smallpox field, mainly in the service of the United States and Russian governments, the AGIES paper is the global public health review of variola virus research that the 60th WHA requested and that the 64th WHA should primarily rely on to inform its deliberations.
The AGIES concludes that no essential public health need now exists for live smallpox virus, meaning that the WHA’s purpose in authorizing temporary retention has been fulfilled. This provides unequivocal justification for the 64th WHA to set a prompt destruction date and finally rid humanity of the smallpox virus.
Despite the strong justifications for destruction, the United States and Russia are expected to oppose any effort at the 64th WHA to set a new date for destruction and to terminate the smallpox research programme.
In an opinion piece written for the New York Times on 25 April 2011, Kathleen Sebelius, the United States Secretary of Health and Human Services made clear the country’s position: that while the global consensus is for the destruction of the stocks, it is not yet ready to do so.
The argument put forth is that there is more research to be done before safe and effective vaccines and antiviral drugs are fully developed and approved for use.
This contrasts sharply with the view of the AGIES, which concludes that smallpox virus is no longer needed for vaccine or antivirals research because of the dangers the research poses and because alternative animal models utilizing related orthopoxviruses may be used for research and regulatory purposes.
The Vaccine editorial also reaches the same conclusion: "Thus, despite the fact that prestigious groups have identified research that requires use of live smallpox virus, what little is necessary can be done or approximated using vaccinia, monkeypox, or partial fragments of the smallpox genome".
D. A. Henderson, who led the WHO’s global smallpox eradication programme, further places the choice before us clearly in a March 2011 article in the journal Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science: "With 2 highly protective vaccines available and the near-completion of work on 2 antiviral drugs, 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 in strengthening the international and national response capabilities for surveillance, containment, and laboratory capabilities? The retention of the existing stocks of smallpox virus are not required for this agenda."
Therefore, the 64th WHA stands at a major crossroads; it could bow to the will of the United States and Russia and continue indefinitely postponing a date for destruction, or it could set a new destruction date for the remaining smallpox virus stocks and terminate smallpox research accordingly.
The destruction of smallpox virus stocks is long overdue. If not now, when?
(Further information can be found at www. smallpoxbiosafety. org) +