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- Research using live variola virus
WHO /Jean Mohr
Following the visit of a WHO Consultant, Pakistan in 1960 undertook a pilot project for the eradication of smallpox in Commilla and Faridpur (then the province of East Pakistan, now Bangladesh), the two worst affected districts during the 1957-58 great epidemic with a combined population of 7,6 million. In Commilla there were 13,594 cases and 9,750 deaths and in Faridpur 17,125 cases and 13,184 deaths. Between January and August 1961 the entire population of the two districts was vaccinated. Freeze-dried vaccine was used. The results were very encouraging. There was no case of smallpox in these two districts until the end of 1962. A small outbreak occurred in 1963 involving 444 cases in Commilla and 34 cases in Faridpur. By 1964 the disease had almost disappeared. Based on the experience gained in the pilot project, a comprehensive plan of smallpox eradication was made. The scheme provided complete protection of the total population of about 50 million to be achieved in two phases during the period from 1961 to 1972. During the first phase of the programme (by September 1963), over 40 million people were protected. Until 1958 the smallpox vaccine production laboratory in Dhaka was producing only wet vaccine but it switched over completely to freeze-dried vaccine. Calf was used in the production of the lymph. The laboratory produced 40 million doses per year which was quite enough to meet the requirements of the campaign. Samples of the vaccine were regularly tested. Some batches were sent to WHO for testing.
© Credits
The period since eradication has been defined by a lengthy, complex and unresolved debate focused on the destruction of the last remaining stocks of live variola virus. This global variola virus stock, consisting of isolates of both variola major and the milder form, variola minor, was restricted to 2 laboratories: the WHO Collaborating Centre on Smallpox and other Poxvirus Infections at the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, USA; and the WHO Collaborating Centre for Orthopoxvirus Diagnosis and Repository for Variola Virus Strains and DNA at the Russian State Research Centre of Virology and Biotechnology (SRC VB VECTOR) in Koltsovo, Novosibirsk Region, Russian Federation.
In 1996, on the advice of the Ad Hoc Committee on Orthopoxvirus Infections, the World Health Assembly made the decision to destroy all existing live variola virus stocks, including those held in the 2 repositories, by June 1999. However, in 1999 at the 52nd Health Assembly there was no longer a consensus on the immediate destruction. Temporary retention of the existing of variola virus stocks remained authorized through resolutions (WHA55.15) in 2002, (WHA60.1) in 2007, and (WHA64.11) in 2011 for the purpose of further essential research.
Advisory Committee for Variola virus Research
The Advisory Committee for Variola virus Research (ACVVR) was convened in 1999 to implement WHA Resolution (WHA52). The ACVVR is composed of members from all WHO regions and advised by scientific academic experts from areas such as public health, fundamental applied research and regulatory agencies to oversee:
- the research using live variola virus
- biosafety and biosecurity inspections of the 2 repository sites
- sequencing the viral genome from variola virus isolates
- distribution of live variola virus DNA to other researchers under specific rules.
ACVVR members
- Dr Priya Abraham
- Dr Fatima Aziz
- Dr Supamit Chunsuttiwat
- Dr Clarissa Damaso
- Dr Inger Damon
- Dr Robert Drillien
- Dr Hideki Ebihara
- Professor Andrew Endy
- Professor Mariano Esteban
- Dr Karupiah Gunasegaran
- Dr Maryam Kamkar
- Dr George Korch
- Dr Jean-Vivien Mombouli
- Dr Mohamed Moussif
- Dr Andreas Nitsche
- Dr Nir Paran
- Professor Geoffrey Smith
- Professor Wenjie Tan
- Dr David Ulaeto
- Dr Christy Hutson (Permanent representatives for WHO Collaborating Centers)
- Dr Alexander Agafonov (Permanent representatives for WHO Collaborating Centers)
Publications and meeting reports
Advisory Group of Independent Experts
In May 2007, the WHA (WHA60.1) requested the Director General (DG) of WHO to undertake a major review, in 2010, of the state of the smallpox research and additional related research needed for global public health purposes. In July 2010, WHO’s DG nominated experts , the Advisory Group of Independent Experts (AGIES) to review the smallpox research programme, which covered 6 areas:
- smallpox vaccines
- laboratory diagnostics
- variola virus genomics
- the status of the 2 WHO repositories of variola virus
- animal models
- antiviral agent.
This review was undertaken to enable the 64th WHA, in 2011, to reach consensus on the timing of the destruction of existing variola virus stocks. The WHA, in resolution WHA64.1 decided, to defer the discussion of the destruction of the existing stocks of variola virus until 2014. In 2013, the AGIES was convened for its second meeting to advise the 67th WHA of May 2014.
The majority of AGIES concluded that there was no need to retain live variola virus for further research in diagnostics, additional sequencing of the genome, use in animal models, or development of additional vaccines or antiviral agents. This differed from the majority view of the ACCVR, who concluded, at their 15th meeting, that the live variola virus was needed for the development of antiviral agents against smallpox. The two expert groups agreed that live virus was no longer required for the development of vaccines or diagnostics.
Handling and synthesis of variola virus DNA
The scientific community must be fully aware that the distribution, synthesis and handling of variola virus DNA is governed by a series of recommendations developed initially by the WHO Ad Hoc Committee on Orthopoxvirus Infections in (1994) and updated by the WHO Advisory Committee on Variola Virus Research.
These recommendations, endorsed by the World Health Assembly, are to prevent the reconstruction of variola virus or the construction of a virus which will cause a disease with the same attributes as smallpox, either through the reactivation of variola virus DNA or the incorporation of variola virus DNA sequences into other orthopoxviruses.
An appropriate research laboratory may submit a formal request to the WHO Secretariat. Only upon approval of this request, can the variola virus DNA fragments be obtained from either one of the two WHO Collaborating Centres, acting as international repositories for variola virus. Scientists should be aware that the amount of DNA they request or hold must not exceed 20% of the total variola virus genome.
The full recommendations are available here:
