Third World Network Research Note


Observations on Destruction of Smallpox Virus Stocks at the 65th WHA

The Major Review of smallpox eradication at the 64th WHA in 2011 concluded with a decision to postpone a resolution on destruction of the stocks until the 67th WHA in 2014. At the 65th WHA, as in every year, destruction of smallpox stocks is again on the agenda, however, in 2012 it is an informational item. Smallpox will reappear on the substantive agenda in 2014.

It is too early to conclusively judge the impact of the 2011’s Major Review. On the one hand, it was not possible to set a new destruction date due to the opposition of the United States, Russia, and their supporters. On the other, the results of the Major Review clarify that the public health rationale for continued retention of smallpox stocks is rapidly dwindling towards zero. In this respect, the scientific review[1] and, especially, the report of the Advisory Group of Independent Experts to review the smallpox research programme (AGIES)[2] clarified that the objectives of the WHO-authorized research program have been substantially met.

The 65th WHA is, therefore, a time to ensure that WHO’s Advisory Committee on Variola Virus Research (ACVVR) is acting in accordance with the conclusions of the Major Review and Member States. The result that should be visible here is a substantial narrowing in the number and types of research protocols involving live variola virus that are currently active.

For example, because the Major Review concluded that sufficient strains have been sequenced and that sufficient rapid and accurate diagnostics exist, the ACVVR should have acted to halt research in those areas. In fact, based on the Major Review, the only WHO-approved research area for which there remains significant scientific rationale is refinement of the animal model to enable regulatory approval of two smallpox antiviral drugs (ST-246 and CMX001) in the United States.[3]

The information provided by the Secretariat to the 65th WHA,[4] however, does not clarify whether or not the ACVVR is in fact acting to wind down research in accordance with the Major Review and outcome of the 65th WHA. A major reason why this is not clear relates to the timing of WHO oversight of smallpox research. While the whole ACVVR meets annually, typically in late November or early December, research protocols are approved by a scientific subcommittee that meets electronically, and acts on protocols at other times, notably March, when a number of large US protocols have, in recent years, been renewed. WHO has not reported on recent renewal/approval/denial/expiry of protocols, leaving Member States with quite dated information – in some cases with no update on protocol status since March 2011, more than a year ago.

Because the timing of research protocol review and approval does not coincide with reporting to the WHA, the information made available to Member States for the 65th WHA does not provide an up-to-date list of active smallpox virus projects with which the effects of the Major Review can be assessed. Member States don’t know if the ACVVR has reduced research, maintained it, or even increased it.

Having an up-to-date list is very important now, and will become more important as the 2014 substantive consideration approaches. Therefore, Member State should:

• Request that the Secretariat inform Member States at the 65th WHA of the list of currently approved research protocols involving live variola virus, including their approval and renewal or expiration dates. (This will enable up-to-date assessment of the status of the research program.)

• Request that the Secretariat, in the future, provide this up-to-date information in its reports to the WHA and Executive Board and maintain an up-to-date list of active protocols on the WHO website.[5]

Another important aspect of the WHA’s decision on destruction of smallpox virus stocks in 2011 was to maintain the AGIES group and continue its mandate. This group is particularly important because it assesses the smallpox research program from a broad public health standpoint, offering a wider perspective than the ACVVR whose outlook is more constricted due to its focus on the details of orthopoxviruses.

 As far as can be determined, however, the AGIES has not met or made any additional comment on the WHO smallpox research programme since its report to the 64th WHA. Maintaining the vitality of the AGIES is important, particularly as 2014 approaches, and at the 65th WHA, Member States may wish to underscore the group’s importance and their expectation of additional review of the research programme by the AGIES.

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[1] WHO/HSE/GAR/BDP/2010.3

[2] WHO/HSE/GAR/BDP/2010.4

[3] We have previously argued, as have many scientific and public health experts, that even this work is not warranted, due to the fact that the many previous experiments to develop the animal model have failed to create a reliable system to mimic human smallpox infection. We continue to endorse the position that the animal model research should be dropped, however, others wish to see it continue, in part because of hopes that animal data will convince the US Food and Drug Administration to license the candidate antiviral drugs.

[4] See page 13 of the Progress reports from the Secetariat (A65/26) and the ACVVR meeting report, WHO/HSE/GAR/BDP/2011.2.

[5] i.e. available from this URL: http://www.who.int/csr/disease/smallpox/en/index.html