The controversy over H5N1 transmissibility research

Fedson, David S.; Opal, Steven M.

doi:10.4161/hv.23869

Cited by 6 publications

(3 citation statements)

References 123 publications

(137 reference statements)

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“…They are the only effective ways to prevent infection and treat illness [ 4 ], and their availability plays a key role in the event of a pandemic. Evidence has been obtained from the relatively mild 2009 H1N1 influenza pandemic which demonstrated that vaccines and antiviral drugs were not readily available in time for more than 90% of the world’s population [ 5 ]. Antiviral drugs can give responsive protection against influenza virus and are useful for containment at the beginning of a pandemic, but in the long term, infection control depends on vaccination [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future

et al. 2014

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Serological techniques commonly used to quantify influenza-specific antibodies include the Haemagglutination Inhibition (HI), Single Radial Haemolysis (SRH) and Virus Neutralization (VN) assays. HI and SRH are established and reproducible techniques, whereas VN is more demanding. Every new influenza vaccine needs to fulfil the strict criteria issued by the European Medicines Agency (EMA) in order to be licensed. These criteria currently apply exclusively to SRH and HI assays and refer to two different target groups—healthy adults and the elderly, but other vaccine recipient age groups have not been considered (i.e., children). The purpose of this timely review is to highlight the current scenario on correlates of protection concerning influenza vaccines and underline the need to revise the criteria and assays currently in use. In addition to SRH and HI assays, the technical advantages provided by other techniques such as the VN assay, pseudotype-based neutralization assay, neuraminidase and cell-mediated immunity assays need to be considered and regulated via EMA criteria, considering the many significant advantages that they could offer for the development of effective vaccines.

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Section: Introductionmentioning

confidence: 99%

Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future

et al. 2014

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“…Vaccines and antiviral drugs are the only effective ways to prevent influenza infection and treat illness [ 20 ], and their availability plays a key role in the event of a pandemic. During the relatively mild 2009 H1N1 influenza pandemic, vaccines did not become available until six months after the pandemic strain had been identified [ 21 ]; as a result, more than 90% of the world’s population did not have timely access to vaccines and antiviral drugs [ 22 ].…”

Section: Introductionmentioning

confidence: 99%

Emerging Influenza Strains in the Last Two Decades: A Threat of a New Pandemic?

et al. 2015

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In the last 20 years, novel non-seasonal influenza viruses have emerged, most of which have originated from birds. Despite their apparent inability to cause pandemics, with the exception of H1N1 swine influenza virus, these viruses still constitute a constant threat to public health. While general concern has decreased after the peak of the H5N1 virus, in recent years several novel reassorted influenza viruses (e.g., H7N9, H9N2, H10N8) have jumped the host-species barrier and are under surveillance by the scientific community and public health systems. It is still unclear whether these viruses can actually cause pandemics or just isolated episodes. The purpose of this review is to provide an overview of old and novel potential pandemic strains of recent decades.

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“…The concern is that if the methods for engineering potentially pandemic strains of influenza were made public, terrorists may use these methods to cause harm to populations. The NSABB initially recommended censorship of publication of full research methods, but later, after an outcry from scientists, reversed the decision in 2012 (Fedson and Opal 2013). The governance of DURC has been questioned after this decision, with questions raised about process, conflicts of interest, lack of transparency, and decision-making in the NSABB (Brown 2012;Roos 2014).…”

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confidence: 99%

Re-thinking the ethics of dual-use research of concern on transmissible pathogens

MacIntyre

2015

Environ Syst Decis

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Rapid acceleration in the science of genetic engineering of infectious diseases has outpaced legal and ethical frameworks for dealing with such research. Dualuse research of concern (DURC), which can be used for good or for harm, raises new questions about potential harm to human beings which have not traditionally been considered by medical research ethics committees, and may require us to revise and standardize ethical guidelines worldwide for the conduct of such research. The weighing of harm versus benefit of research as traditionally considered on an individual level needs to be considered on a population level for infectious diseases DURC, and on a global level due to the potential for transmissible infections to cause a pandemic, thus affecting people in places far from where the research was conducted. The harm of such research could result from either laboratory accidents or bioterrorism. As an example, engineered organisms such as influenza could result in an unnatural pandemic, affecting and harming people who were never informed of the research nor consented to it. The debate to date has been held among medical researchers and has been focused on the rights of researchers and scientific freedom. The community is also a stakeholder with rights, and DURC done in one country could cause harm to people in other countries who were never included in the debate. The first requirement is to inform and engage the public as a stakeholder in such research, and to make deliberations about DURC public and transparent. Secondly, governance structures and guidelines are not uniform internationally, and only some institutions and countries have specific DURC policies, none of which are enforceable. Consistent international guidelines and uniform, enforceable global governance models need to be developed for medical research ethics committees around potential population harm and benefit of DURC. Finally, researchers should be required to quantify potential population risks and benefits of DURC before it is approved. Models for quantifying risk-benefit equations could be drawn from health economics, with the onus on researchers to demonstrate that potential benefit outweighs potential harm. These would be positive steps towards protecting the interests and rights of all potentially affected populations in the case of transmissible infectious disease DURC. Past quantum changes in medical research governance such as mandatory registration of clinical trials show that major changes in research culture can be achieved. Current systems leave community stakeholders vulnerable to potential harms of infectious diseases DURC, and need to be addressed in a consistent and comprehensive manner internationally to ensure ethical obligations are met.

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The controversy over H5N1 transmissibility research

Cited by 6 publications

References 123 publications

Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future

Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future

Emerging Influenza Strains in the Last Two Decades: A Threat of a New Pandemic?

Re-thinking the ethics of dual-use research of concern on transmissible pathogens

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