Sundheds- og Ældreudvalget 2016-17
SUU Alm.del Bilag 336
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SIXTY-NINTH WORLD HEALTH ASSEMBLY
Provisional agenda item 14.3
A69/23
22 April 2016
Smallpox eradication: destruction of
variola virus stocks
Report by the Secretariat
1.
The Executive Board at its 138th session noted an earlier version of this report.
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The version of
the report that follows has been updated (paragraphs 6, 7 and 13–19).
2.
This document reports on work undertaken by the Secretariat in preparation for the Sixty-ninth
World Health Assembly. It summarizes the conclusions of the Independent Advisory Group on Public
Health Implications of Synthetic Biology Technology Related to Smallpox, which was established at
the request of Member States and met in Geneva at the end
of June 2015. It reports on the WHO’s
biosafety inspections of the two variola virus repositories in 2014–2015. It also summarizes the work
being carried out on the operational framework for access to WHO’s smallpox vaccine stockpile and
the conclusions of the WHO Advisory Committee on Variola Virus Research (Geneva, 12 and
13 January 2016).
SECRETARIAT ACTIONS
Independent Advisory Group on Public Health Implications of Synthetic Biology
Technology Related to Smallpox
3.
At the Sixty-seventh World Health Assembly, in May 2014, WHO was requested to provide
additional information to the Health Assembly on the use and potential impact of technologies for
synthetic biology on smallpox preparedness and control, to assist the Health Assembly in its
deliberations on the timing of the destruction of existing variola virus stocks.
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4.
In response to that request, the Secretariat convened a meeting of a group of experts
–
the
Independent Advisory Group on Public Health Implications of Synthetic Biology Technology Related
to Smallpox
–
to provide an up-to-date assessment of technologies for synthetic biology and their
potential impact on smallpox preparedness and countermeasure development.
See document EB138/22 and the summary record of the Executive Board at its 138th session, seventh meeting,
section 2 (document EB138/2016/REC/2).
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See document WHA67/2014/REC/3, summary record of the twelfth meeting of Committee A, section 8.
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5.
Prior to that meeting, the Secretariat convened a meeting of a Scientific Working Group, which
was held in Geneva on 16 and 17 April 2015, with the aim of providing the Independent Advisory
Group with the most current scientific information on synthetic biology technology with regard to the
variola virus. The report of the Scientific Working Group served as the background document for the
meeting of the Independent Advisory Group.
6.
The Independent Advisory Group met in Geneva on 29 and 30 June 2015. It concluded that the
risk of the re-emergence of smallpox has increased. The creation of variola virus using information on
DNA sequences will be easier and cheaper in the future and may be possible in small laboratories with
inadequate biosafety and biosecurity for handling variola virus.
7.
The Independent Advisory Group therefore recommended: (1) to increase significantly
preparedness efforts to ensure that early detection and rapid response capacities for a potential
smallpox re-emergence are widely available; and (2) to revise the WHO regulations for the handling of
variola virus (whole virus or fragments) with a special emphasis on biosafety and biosecurity rules to
reduce and minimize the risk of a laboratory accident that may occur from the widespread use of
synthetic biology technology.
8.
The full report of the Independent Advisory Group, including the conclusions of the Scientific
Working Group is available on the WHO website.
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Biosafety inspection of the repository sites
9.
WHO biosafety inspection teams visited and inspected the containment facilities at the two
WHO collaborating centres that are the authorized repositories of variola virus: the State Research
Centre for Virology and Biotechnology (Koltsovo, Novosibirsk Region, Russian Federation) and the
Centers for Disease Control and Prevention (Atlanta, Georgia, United States of America), in
December 2014 and May 2015 respectively. The final reports of these two biosafety inspections will
soon be available on the WHO website.
10.
The protocol that was used followed the European Committee for Standardization’s Laboratory
Biorisk Management Standard CWA 15793:2011, which covers 16 elements of laboratory biorisk
management. The biosafety inspection visits of 2014–2015 confirmed that this approach allows for
effective inspections of the repositories, helping to assure the wider community that the research
therein is being done safely and securely, in line with the highest standards of biosafety and
biosecurity. The WHO inspection team included international experts and WHO staff and involved the
other repository’s staff as observers. The inspections included
discussions with the respective
repository’s staff and with senior management; a detailed review of the facility; a review of the
updates and corrective actions taken since the last inspection; and a review of documents, records,
regulatory instruments and other materials of relevance. The next biosafety inspections of the two
repositories of variola virus are planned for 2016–2017.
The Independent Advisory Group on Public Health Implications of Synthetic Biology Technology Related to
Smallpox: meeting report. Geneva: World Health Organization; 2015 (document WHO/HSE/PED/2015. 1;
http://www.who.int/csr/resources/publications/smallpox/synthetic-biology-technology-smallpox/en/, accessed 5 April 2016).
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Operational framework for access to WHO’s smallpox vaccine stockpile
11. Work continues on an operational framework for access
to WHO’s emergency stockpile of
smallpox vaccine in response to a smallpox event. The framework includes legal considerations for
donating smallpox vaccines, standard operating procedures for both donor countries and recipient
countries, logistical requirements and a vaccine request form, with terms and conditions for the
donation and reception of smallpox vaccines. The Secretariat has begun discussions with the national
regulatory agencies of donating countries on the creation of a regulatory framework for the donation of
smallpox vaccines.
WHO Advisory Committee on Variola Virus Research
12. The Seventeenth meeting of the WHO Advisory Committee on Variola Virus Research was
held in Geneva on 12 and 13 January 2016.
13. The Advisory Committee received reports on the virus collections held at the two authorized
repositories of variola virus, in the Russian Federation and the United States of America. It was also
provided with updates on the continuation of research projects using live variola virus for the
development of diagnostic tests, animal models, smallpox vaccines, and antiviral and therapeutic
agents. As concluded in the Fifteenth meeting of the Advisory Committee (24 and 25 September
2013),
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the only new projects that have been approved are for antiviral agents against smallpox. The
Advisory Committee discussed the estimated timelines for the ongoing research projects and expects
that the completion and final review of these projects will take a minimum of three years.
14. The full report of the Advisory Committee is accessible on the WHO website.
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The major
conclusions are presented below.
15. The Advisory Committee noted the conclusion of the Independent Advisory Group on Public
Health Implications of Synthetic Biology Technology Related to Smallpox that the nature of the risk
of re-emergence of smallpox has changed significantly and is evolving.
16. The Advisory Committee concluded that there was no need to increase the number of sites
where research using live variola virus could be undertaken beyond the two existing authorized global
repositories. However, it recommended that more laboratories around the world should develop
capacity for smallpox diagnostics which did not need live variola virus.
17. The Advisory Committee recognized the need for increased preparedness to deal with the
potential consequences of the synthesis and possible re-emergence of variola virus and encouraged the
expansion of expertise in the area of laboratory biosafety and biosecurity and diagnostics for this
purpose.
18. Given the change in the risk of re-emergence of smallpox due to advances in synthetic biology
technology, the Advisory Committee reviewed its terms of reference and concluded that they were
broad enough to include the area of synthetic biology technology, if necessary. However, the Advisory
See document A67/37 and Report of the Fifteenth Meeting WHO Advisory Committee on Variola Virus Research
(http://www.who.int/csr/resources/publications/smallpox/WHO_HSE_PED_CED_2013_2/en/, accessed 5 April 2016).
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http://www.who.int/csr/resources/publications/smallpox/variola-research-2016/en/ (accessed 21 April 2016).
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Committee agreed that additional members, with appropriate expertise related to new technologies,
such as synthetic biology, would be welcome. The Advisory Committee gave special attention in its
review of the current research agenda to assessing whether there are or will be additional needs for
smallpox control measures in case of re-emergence of a synthetized and/or modified variola virus.
19. Finally, as recommended by the Independent Advisory Group on on Public Health Implications
of Synthetic Biology Technology Related to Smallpox, the Advisory Committee revised the
WHO
recommendations concerning the distribution, handling and synthesis of variola virus DNA,
the text of
which can be found on the WHO website.
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The Advisory Committee specified that permission to
express one or more variola virus genes must be sought from the Secretariat. The Advisory Committee
further strongly recommended that the revised recommendations be widely distributed and adopted by
Member States as part of their national biosafety regulations.
ACTION BY THE HEALTH ASSEMBLY
20.
The Health Assembly is requested to note the report.
21. Given the minimum estimated timeline for the completion of ongoing, approved research, and
the need for the Advisory Committee on Variola Virus Research to give further consideration to the
implications of synthetic biology for the research agenda, the Secretariat proposes that the Health
Assembly decide to include a substantive item entitled “Smallpox eradication:
destruction of variola
virus stocks” on the provisional agenda of the Seventy-second
World Health Assembly.
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www.who.int/csr/disease/smallpox.
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