TWN Info Service on Health
Issues No. 6
At WHA, countries express concern over smallpox research
By Edward Hammond
and Lim Li Ching
Concern over the recommendations
of a WHO scientific committee to allow research involving genetic engineering
of the smallpox virus was expressed by many countries at a meeting of
the World Health Assembly (WHA) on Thursday and Friday.
The countries were worried about the possible risks posed by more dangerous
forms of the variola (smallpox) virus and by possible laboratory accidents
or accidental release of the virus into the environment.
At the end of the discussion,
the head of WHO's division on Communicable Diseases, Dr Asamoa-Baah
said the Secretariat took special note of the "concerns and caution"
raised by many countries. He added that with regard to the recommendations
of the scientific committee, the WHO especially welcomed the countries'
views that the committee be asked to revisit and review their recommendations.
The Chairman of Committee
A, in which the discussion took place, then noted the Secretariat reports
and closed discussion on the agenda item.
It was not immediately clear
whether there would be further action by the WHA on the issue or how
the WHO Secretariat will follow up on it.
The agenda item, "destruction
of variola virus stocks", had been one of the WHA's most controversial
issues. Contrary to the title of the agenda item, the WHA was actually
considering a set of recommendations from the WHO's advisory committee
on variola virus research that would dramatically expand research on
live smallpox virus, rather than destroy the last remaining stocks of
the virus, as previous sessions of the WHA had agreed to do.
Many scientists and NGOs
had voiced opposition to the committee's five recommendations, involving
the genetic engineering of the small pox virus to express a green fluorescent
market protein; the expression of the smallpox virus genes in other
orthopoxviruses; the simultaneous handling of the smallpox virus and
other orthopoxviruses; the in vitro synthesis of variola virus DNA and
mutagenesis of orthopoxvirus DNA; and the distribution of the virus
DNA to other laboratories.
In a report for the WHA,
the WHO secretariat said the recommendations had been reviewed by the
Director General, who expressed that such research (referring to the
proposal to allow expression of smallpox virus genes in other orthopoxviruses)
"could have broader implications, including certain biosafety and
biosecurity concerns". He recommended that this issue be reconsidered
by the committee.
Due to WHO-coordinated actions,
the smallpox disease has been eliminated. However, the WHA allowed small
stocks of the smallpox virus to be held in two laboratories (in the
US and Russia) for research purposes, but had resolved that they be
The destruction of the virus
has been postponed several times, and instead the programme of research
has expanded. The present recommendations are the first to involve genetic
engineering, and to allow transfer of the virus DNA to other laboratories.
Seven countries made interventions
on Thursday, and sixteen more spoke on Friday.
As expected, the two countries
that hold the virus stocks (Russia and the US) spoke in favour of prolonging
the period of research and supported the committee's recommendations.
Russia endorsed the recommendations
for more research and also in particular asked for the right to continue
to utilize live smallpox virus in research on diagnostics, an area of
research that WHO has concluded no longer requires live virus.
The US stated that it "agrees
entirely with Russia", which had earlier called for even more live
virus research than the recommendations presented by the VAC. Noting
the possibility of undeclared smallpox stocks, the US said that its
research is not finished and that setting a date for destruction would
be "arbitrary" and "not at all warranted". In response
to a statement by Canada, the US strongly defended its own antiviral
Apparently smarting from
repeated references by other countries to lab accidents, the US characterized
the chances of an accident as "incredibly small" and claimed
that existing smallpox stocks are held at "the absolute highest
standards of biosafety and biosecurity".
It is, however, unclear to
what standards the US referred to because there are no international
lab biosafety or biosecurity standards, nor does the US have domestic
lab biosafety standards. Backing Russia, the US said that it believed
further sequencing of the Russian smallpox stocks is necessary for developing
Australia expressed support
for the controversial recommendations, including the genetic engineering
of smallpox and wider distribution of smallpox DNA. On the issue of
Russia's desire to continue to use live smallpox virus to develop diagnostics,
Australia's answer was ambiguous.
It said that diagnostic tests
could be validated with smallpox scabs from monkeys, a position that
implicitly endorses US work injecting monkeys with large amounts of
smallpox virus, research that is particularly dangerous. Australia did,
however, share the WHO Director General's concern that smallpox genes
should not be inserted into related poxviruses.
In contrast to the strong
support for the committee's recommendations by these three countries,
many other countries expressed concerns ranging from caution to expressions
of anxiety and suggestions that the research on smallpox be stopped.
In a detailed intervention,
China underscored the public health risks of the virus escaping from
the lab and called for strengthening WHO oversight of smallpox virus
research. It noted that existing vaccines and control strategies could
respond to emergencies and that the benefits of destroying remaining
virus stocks are greater than those of continued research with the live
virus. China called for the WHA to set a deadline for destruction of
remaining virus stocks.
Iran took the floor reiterating
China's observation that existing vaccines can be used in the event
of a smallpox outbreak. Recalling recent laboratory accidents involving
tularemia (in the US) and SARS (in Taiwan, Singapore, and China), Iran
argued that the risks posed by escape of smallpox virus were too high
to justify continued research on the eradicated disease and strongly
endorsed destruction of the remaining virus stocks.
Japan urged rapid conclusion
of ongoing research, and called for transparency. Japan said that the
results should be "the property of all nations and human beings".
South Africa reminded delegates
of the WHA's previous commitment to destroy the remaining live virus
stocks, held in two labs, one in the US and the other in Russia. Taking
a strong stance, South Africa called for research on the live virus
to be stopped. It proposed the establishment of a 'task team', with
better balance and broader representation than the Variola Advisory
Committee (VAC). The 'task team' would evaluate the status of work with
live smallpox virus and its oversight.
South Africa called for a
review of all the VAC recommendations, including the genetic engineering
of smallpox and the wider distribution of smallpox DNA, as well as that
to permit expression of smallpox genes in related poxviruses, an item
that the WHO Director General had already expressed concern over. Another
report should be submitted to the WHA on the issue.
The Netherlands said that
in relation to the plans for research involving genetic engineering
of the virus, it was concerned about the potential dangers. It was not
satisfied that adequate protections to take care of safety concerns
are in place. It questioned the need to genetically engineer smallpox.
The Netherlands supported the Director General's call for a reconsideration
of the committee's recommendations. It called for an independent body
to oversee research. It asked that a report on the reconsideration of
the recommendations be submitted to the WHA through the WHO's Executive
Canada reminded delegates
that any research on smallpox should remain geared to precise results
and be time-limited. Canada insisted that any live virus research "must
be essential for public health". In this respect, Canada, expressed
concerns that US research on antivirals (linked to the proposal to genetically
engineer smallpox) would be lengthy and costly, asking "Is this
really essential for public health?"
Like many other delegations,
Canada was concerned about the risks of laboratory accidents. It also
raised concern that genetic engineering experiments could result in
a virus that is more dangerous that the existing smallpox virus. It
supported the Director General's concern regarding the committee's recommendations
and asked that the matter be referred to the next WHA meeting. Canada
called for prompt destruction of the virus once there is no public health
reason to maintain it, and expressed support for China's request that
WHO follow up on the issue of fixing a new date for the destruction
of smallpox virus stocks.
The Pacific island nation
of Tonga weighed in with a lengthy intervention. Referring to the committee's
proposal to distribute the smallpox DNA to other laboratories, it said
there were many brilliant and responsible scientists all over the world
but there are a few who may be different and there was a possibility
that some scientists can use pieces of DNA material to reconstruct the
smallpox virus and this could possibly fall in the hands of terrorists.
Could the committee say that it is not possible? Tonga was thus very
worried about the possibility.
Tonga also said that it is
not convinced that the prohibition on the synthesis of smallpox DNA,
mentioned in the Secretariat report, was strong enough. Concerned about
the proposed widespread distribution of smallpox DNA, Tonga observed
that "too many hands on smallpox virus and the dangerous DNA materials
relating to it will enhance the possibility of bioterrorism".
Tonga concluded that there
should be a process to make it a crime against humanity for any person
or laboratory to hold on to the smallpox virus excepting for the two
laboratories. It called for the existing "official" stocks
of the smallpox virus in the two labs to be targeted for destruction
sooner rather than later.
Cuba said a number of countries
feared the possibility of lab accidents or bioterrorism, and thus wanted
to maintain reserves of the vaccine. It said there should be a final
date set for the destruction of the smallpox virus. There was a risk
of genetic mutation of the virus, for which there is no effective vaccine.
Egypt briefly stated that
it supports the research recommended by the committee.
Saudi Arabia noted that sufficient
sequencing and diagnostics research has been conducted and that smallpox
virus should no longer be retained for these purposes. Saudi Arabia
said that all research and manipulation using live virus should end,
and we should set a date for destruction of the virus, as previously
mandated by the WHA.
Pakistan said it could agree
to the retention of virus stocks for a limited period. It called for
the virus repositories to be open to full inspection and for a comprehensive
system of oversight and for research results to be published.
The UK supported ongoing
research for the development of vaccines and antivirals, adding that
such research be outcome oriented and time limited. However, the UK
"strongly" shared the WHO Director General's biosafety and
biosecurity concerns about the committee's proposals, and said it has
implications for members states. The UK said we need to be assured that
all research is under WHO control and that live smallpox virus should
not be proliferated.
Zimbabwe supported South
Africa's call for a more representative 'task team' to reassess live
smallpox virus work and its oversight and that developing countries
be added onto the team. It supported greater research transparency and
for the WHA to be kept informed.
Thailand reminded the WHA
of its previous resolutions calling for destruction of remaining stocks.
Thailand expressed reservations about the ill-defined limits of permissible
research in the Secretariat's report. It was also concerned about the
proposed wider distribution of smallpox DNA and said that such distribution
should be decided by WHO on a case-by-case basis.
Some other countries (including
France, Germany and India) spoke up on a related issue (the proposal
to maintain reserve stocks of smallpox vaccine) but did not refer to
the issue of the recommendations for expanded smallpox research.
Responding on behalf of the
WHO Secretariat, Dr Asamoa-Baah said the Secretariat took note of the
Russian, Australian and US interventions. It also took special note
of the "concerns and caution" articulated by a large number
of countries (which he named). He added that the Secretariat especially
welcomed the views, that with regards to the committee's recommendations,
that we ask the committee to "revisit and review their recommendations."
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