Pandemic Influenza Preparedness Research Articles

Are prison settings included in national preparedness plans?

Abstract With the aim to explore the extent to which places of detention are considered in national preparedness planning in the WHO European Region, a desktop review was conducted and combined with responses to the Health in Prisons European Database (HIPED) survey from Member States referring to 2020. In both searches, the aim was to identify the existence of: 1) national pandemic preparedness plans written prior to the COVID-19 pandemic; and 2) national pandemic preparedness and response plans specific to the COVID-19 pandemic. Where prisons were included, all aspects of pandemic preparedness relating to prisons were extracted and collated as per the main domains of the WHO checklist for influenza pandemic preparedness plans. The desktop review found that 30 Member States had pandemic plans accessible online, but only seven included any mention of prisons. Responses to the HIPED survey suggested wide dissemination of a COVID-19 preparedness and/or response plan, but only six out of 36 Member States referred to prisons or the vulnerabilities of people living in places of detention. The combined findings suggest that prisons are rarely considered in national planning and that lessons from previous pandemics have not led to a change in recognizing that prisons are high-risk environments for pathogen transmission and that failing to consider them in national planning may lead to impacts that affect the wider community.

The 2021-2023 Italian influenza pandemic plan: a critical evaluation of its regional implementation

Abstract Background Influenza pandemic preparedness plans should be adopted, regularly updated in every country, and comply with international guidelines to ensure proper management of public health emergencies. In Italy, each region develops its pandemic plan based on a National Plan. This study, conducted within a project funded by the Italian Ministry of Health, aims to assess the level of compliance of these plans with the national guidelines. Methods The assessment was based on a checklist of 192 items reporting the actions prescribed by the national plan. The items were divided into macro-areas by pandemic phase: general, alert, inter-pandemic, pandemic, and transition. The compliance regarding the presence and contextualization of each item in the regional plans was evaluated. Each macro-area was further assessed for easy identification of actions, congruence with the National Plan, and contextualization in the regional healthcare system. Some analyses grouped the regions into North, Centre, and South/Islands. Results Some macro-areas, such as ‘Communication’ and ‘Prevention and Control measures,’ showed some weaknesses in all phases, especially in the northern regions, which reached levels of full compliance below 50%. Central regions were highly compliant in almost all macro-areas, especially in ‘Strategy/Governance’ (100%), ‘Supplying’ (75-100%), and ‘Surveillance’ (75-100%). Overall, contextualization was the weakest aspect in all phases, while easy identification and congruence were mainly better achieved. Only three regions fully met all the assessed parameters. Conclusions A strict surveillance and monitoring process of planned activities is necessary to strengthen the country’s preparedness. This study identified critical issues and key areas for improvement at the regional level. This might allow us to verify the correct implementation of national guidelines and define the best strategies for improving readiness for public health emergencies in the future. Key messages • Implementation of the Italian influenza pandemic plan was uneven across regions. • Identification of lacking areas of the regional implementation is essential to improving national preparedness.

Pandemic preparedness and health system resilience in 14 European countries.

To assess national pandemic preparedness and response plans from a health system perspective to determine the extent to which implementation strategies that support health system performance have been included. We systematically mapped pandemic preparedness and response implementation strategies that improve resilience to pandemics onto the Health System Performance Assessment Framework for Universal Health Coverage. Using this framework, we conducted a document analysis of 14 publicly available national influenza pandemic preparedness plans, submitted to the European Centre for Disease Prevention and Control, to assess how well health system functions are accounted for in each plan. Implementation strategies found in national influenza pandemic preparedness plans do not systematically consider all health system functions. Instead, they mostly focus on specific aspects of governance. In contrast, little to no mention is made of implementation strategies that aim to strengthen health financing. There was also a lack of implementation strategies to strengthen the health workforce, ensure availability of medical equipment and infrastructure, govern the generation of resources and ensure delivery of public health services. While national influenza pandemic preparedness plans often include provisions to support health system governance, implementation strategies that support other health system functions, namely, resource generation, service delivery, and in particular, financing, are given less attention. These oversights in key planning documents may undermine health system resilience when public health emergencies occur.

Conflicting Scientific Narratives at the Convention on Biological Diversity and Other Fora: Analysis and Contradiction in the Discussions on Dematerialization of (Plant) Genetic Resources

This article examines the use of scientific arguments in negotiations on the status of Digital Sequence Information (DSI), focusing on the Convention on Biological Diversity (CBD), the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), and the Pandemic Influenza Preparedness Framework (PIP). DSI is a placeholder term used in negotiations on the dematerialization of genetic resources: the ability to sequence “physical” genetic resources and use this “intangible” information, which radically changes research practices. The CBD (among other instruments) establishes rules for Access to the Genetic Resource and the Fair and Equitable Sharing of Benefits from their utilization (ABS). This applies to “physical” genetic resources, but it is not clear for DSI. Indeed, different legal interpretations and political narrative are conflicting over the integration of DSI into these legal frameworks. This article explores how science is used in these negotiations, particularly in its rhetorical and epistocratic dimensions. The methodology combines an interdisciplinary approach (legal technique, philosophy of law and science) and a comparative discourse analysis: on the terminology; the inclusion of DSI in the definition of genetic material; and the inclusion of DSI in ABS systems. While scientific arguments play a crucial role in this technical issue, this article shows that scientific arguments can be used to support political positions (under the guise of objectivity and neutrality), and that this use of scientific arguments is not consistent, even contradictory (between PIP and CBD/ITPGRFA).

Pandemic influenza preparedness plan in Liguria, Italy: a valuable tool for Public Health.

As known, influenza presents a multifaceted challenge to public health, causing disease that ranges from mild cases to severe pandemics with significant morbidity and mortality. Effective pandemic preparedness demands a comprehensive strategy that integrates research, surveillance, response coordination and community engagement, to mitigate the impact of future health emergencies. The pandemic preparedness cycle involves dynamic, cyclical phases of preparation and response aimed at enhancing response capacity. Italy's 2021-2023 National Strategic-Operational Plan for Pandemic Influenza (PanFlu) incorporates lessons learned from past pandemics and serves as a framework for regional plans, such as Liguria's. The Ligurian plan delineates governance structures, surveillance strategies, healthcare services and communication measures necessary for effective pandemic management. It emphasizes the need to strengthen links between emergency structures, to avoid duplication and to adopt flexible approaches to scale actions appropriately and highlights the need for risk/benefit analysis to support evidence-based decision-making as well as clear guidance on data collection and communication activities. By integrating these elements, the region's overall readiness and resilience against influenza pandemics are expected to be reinforced.

The impact of PA/I38 substitutions and PA polymorphisms on the susceptibility of zoonotic influenza A viruses to baloxavir

Genetic reassortment of avian, swine, and human influenza A viruses (IAVs) poses potential pandemic risks. Surveillance is important for influenza pandemic preparedness, but the susceptibility of zoonotic IAVs to the cap-dependent endonuclease inhibitor baloxavir acid (BXA) has not been thoroughly researched. Although an amino acid substitution at position 38 in the polymerase acidic protein (PA/I38) in seasonal IAVs reduces BXA susceptibility, PA polymorphisms at position 38 are rarely seen in zoonotic IAVs. Here, we examined the impact of PA/I38 substitutions on the BXA susceptibility of recombinant A(H5N1) viruses. PA mutants that harbored I38T, F, and M were 48.2-, 24.0-, and 15.5-fold less susceptible, respectively, to BXA than wild-type A(H5N1) but were susceptible to the neuraminidase inhibitor oseltamivir acid and the RNA polymerase inhibitor favipiravir. PA mutants exhibited significantly impaired replicative fitness in Madin-Darby canine kidney cells at 24 h postinfection. In addition, in order to investigate new genetic markers for BXA susceptibility, we screened geographically and temporally distinct IAVs isolated worldwide from birds and pigs. The results showed that BXA exhibited antiviral activity against avian and swine viruses with similar levels to seasonal isolates. All viruses tested in the study lacked the PA/I38 substitution and were susceptible to BXA. Isolates harboring amino acid polymorphisms at positions 20, 24, and 37, which have been implicated in the binding of BXA to the PA endonuclease domain, were also susceptible to BXA. These results suggest that monitoring of the PA/I38 substitution in animal-derived influenza viruses is important for preparedness against zoonotic influenza virus outbreaks.

Immunogenicity and safety of varying dosages of a fifth-wave influenza A/H7N9 inactivated vaccine given with and without AS03 adjuvant in healthy adults

BackgroundHuman infections with the avian influenza A(H7N9) virus were first reported in China in 2013 and continued to occur in annual waves. In the 2016/2017 fifth wave, Yangtze River Delta (YRD) lineage viruses, which differed antigenically from those of earlier waves, predominated. MethodsIn this phase 2 double-blinded trial we randomized 720 adults ≥ 19 years of age to receive two injections of a YRD lineage inactivated A/Hong Kong/125/2017 fifth-wave H7N9 vaccine, given 21 days apart, at doses of 3.75, 7.5, and 15 µg of hemagglutinin (HA) with AS03A adjuvant and at doses of 15 and 45 µg of HA without adjuvant. ResultsTwo doses of adjuvanted vaccine were required to induce HA inhibition (HI) antibody titers ≥ 40 in most participants. After two doses of the 15 µg H7N9 formulation, given with or without AS03 adjuvant, the proportion achieving a HI titer ≥ 40 against the vaccine strain at 21 days after the second vaccination was 65 % (95 % CI, 57 %-73 %) and 0 % (95 % CI, 0 %-4%), respectively. Among those who received two doses of the 15 µg adjuvanted formulation the proportion with HI titer ≥ 40 at 21 days after the second vaccination was 76 % (95 % CI, 66 %-84 %) in those 19–64 years of age and 49 % (95 % CI, 37 %-62 %) in those ≥ 65 years of age. Responses to the adjuvanted vaccine formulations did not vary by HA content. Antibody responses declined over time and responses against drifted H7N9 strains were diminished. Overall, the vaccines were well tolerated but, as expected, adjuvanted vaccines were associated with more frequent solicited systemic and local adverse events. ConclusionsAS03 adjuvant improved the immune responses to an inactivated fifth–wave H7N9 influenza vaccine, particularly in younger adults, but invoked lower responses to drifted H7N9 strains. These findings may inform future influenza pandemic preparedness strategies.

Analysis of avian influenza A (H3N8) viruses in poultry and their zoonotic potential, China, September 2021 to May 2022.

BackgroundTwo human cases of avian influenza A (H3N8) virus infection were reported in China in 2022.AimTo characterise H3N8 viruses circulating in China in September 2021-May 2022.MethodsWe sampled poultry and poultry-related environments in 25 Chinese provinces. After isolating H3N8 viruses, whole genome sequences were obtained for molecular and phylogenetic analyses. The specificity of H3N8 viruses towards human or avian receptors was assessed in vitro. Their ability to replicate in chicken and mice, and to transmit between guinea pigs was also investigated.ResultsIn total, 98 H3N8 avian influenza virus isolates were retrieved from 38,639 samples; genetic analysis of 31 representative isolates revealed 17 genotypes. Viruses belonging to 10 of these genotypes had six internal genes originating from influenza A (H9N2) viruses. These reassorted viruses could be found in live poultry markets and comprised the strains responsible for the two human infections. A subset of nine H3N8 viruses (including six reassorted) that replicated efficiently in mice bound to both avian-type and human-type receptors in vitro. Three reassorted viruses were shed by chickens for up to 9 days, replicating efficiently in their upper respiratory tract. Five reassorted viruses tested on guinea pigs were transmissible among these by respiratory droplets.ConclusionAvian H3N8 viruses with H9N2 virus internal genes, causing two human infections, occurred in live poultry markets in China. The low pathogenicity of H3N8 viruses in poultry allows their continuous circulation with potential for reassortment. Careful monitoring of spill-over infections in humans is important to strengthen early-warning systems and maintain influenza pandemic preparedness.

Unconjugated Multi-Epitope Peptides Adjuvanted with ALFQ Induce Durable and Broadly Reactive Antibodies to Human and Avian Influenza Viruses.

An unconjugated composite peptide vaccine targeting multiple conserved influenza epitopes from hemagglutinin, neuraminidase, and matrix protein and formulated with a safe and highly potent adjuvant, Army Liposome formulation (ALFQ), generated broad and durable immune responses in outbred mice. The antibodies recognized specific epitopes in influenza peptides and several human, avian, and swine influenza viruses. Comparable antibody responses to influenza viruses were observed with intramuscular and intradermal routes of vaccine administration. The peptide vaccine induced cross-reactive antibodies that recognized influenza virus subtypes A/H1N1, A/H3N2, A/H5N1, B/Victoria, and B/Yamagata. In addition, immune sera neutralized seasonal and pandemic influenza strains (Group 1 and Group 2). This composite multi-epitope peptide vaccine, formulated with ALFQ and administered via intramuscular and intradermal routes, provides a high-performance supra-seasonal vaccine that would be cost-effective and easily scalable, thus moving us closer to a viable strategy for a universal influenza vaccine and pandemic preparedness.

An appraisal of peer-reviewed published literature on Influenza, 2000-2021 from countries in South-East Asia Region.

Influenza poses a major public health challenge in South-East Asia Region (SEAR). To address the challenge, there is a need to generate contextual evidence that could inform policy makers and program managers for response preparedness and impact mitigation. The World Health Organization has identified priority areas across five streams for research evidence generation at a global level (WHO Public Health Research Agenda). Stream 1 focuses on research for reducing the risk of emergence, Stream 2 on limiting the spread, Stream 3 on minimizing the impact, Stream 4 on optimizing the treatment and Stream 5 on promoting public health tools and technologies for Influenza. However, evidence generation from SEAR has been arguably low and needs a relook for alignment with priorities. This study aimed to undertake a bibliometric analysis of medical literature on Influenza over the past 21 years to identify gaps in research evidence and for identifying major areas for focusing with a view to provide recommendations to member states and SEAR office for prioritizing avenues for future research. We searched Scopus, PubMed, Embase, and Cochrane databases in August 2021. We identified studies on influenza published from the 11 countries in WHO SEAR in the date range of 1 January 2000-31 December 2021. Data was retrieved, tagged and analyzed based on the WHO priority streams for Influenza, member states, study design and type of research. Bibliometric analysis was done on Vosviewer. We included a total of 1,641 articles (Stream 1: n = 307; Stream 2: n = 516; Stream 3: n = 470; Stream 4: n = 309; Stream 5: n = 227). Maximum number of publications were seen in Stream 2, i.e., limiting the spread of pandemic, zoonotic, and seasonal epidemic influenza which majorly included transmission, spread of virus at global and local levels and public health measures to limit the transmission. The highest number of publications was from India (n = 524) followed by Thailand (n = 407), Indonesia (n = 214) and Bangladesh (n = 158). Bhutan (n = 10), Maldives (n = 1), Democratic People's Republic of Korea (n = 1), and Timor-Leste (n = 3) had the least contribution in Influenza research. The top-most journal was PloS One which had the maximum number of influenza articles (n = 94) published from SEAR countries. Research that generated actionable evidence, i.e., implementation and intervention related topics were less common. Similarly, research on pharmaceutical interventions and on innovations was low. SEAR member states had inconsistent output across the five priority research streams, and there was a much higher scope and need for collaborative research. Basic science research showed declining trends and needed reprioritization. While a priority research agenda has been set for influenza at the global level through the WHO Global Influenza Program since 2009, and subsequently revisited in 2011 and again in 2016-2017, a structured contextualized approach to guide actionable evidence generation activities in SEAR has been lacking. In the backset of the Global Influenza Strategy 2019-2030 and the COVID-19 pandemic, attuning research endeavors in SEAR could help in improved pandemic influenza preparedness planning. There is a need to prioritize contextually relevant research themes within priority streams. Member states must inculcate a culture of within and inter-country collaboration to produce evidence that has regional as well as global value.

An oseltamivir-resistant avian H1N1 influenza A virus can transmit from mallards to chickens similarly to a wild-type strain: implications for the risk of resistance transmission to humans.

The neuraminidase inhibitor (NAI) oseltamivir is stockpiled globally as part of influenza pandemic preparedness. However, oseltamivir carboxylate (OC) resistance develops in avian influenza virus (AIV) infecting mallards exposed to environmental-like OC concentrations, suggesting that environmental resistance is a real concern. Herein we used an in vivo model to investigate if avian influenza H1N1 with the OC-resistant mutation NA-H274Y (51833/H274Y) as compared to the wild-type (wt) strain (51833 /wt) could transmit from mallards, which would potentially be exposed to environmentally contaminated environments, to and between chickens, thus posing a potential zoonotic risk of antiviral-resistant AIV. Regardless of whether the virus had the OC-resistant mutation or not, chickens became infected both through experimental infection, and following exposure to infected mallards. We found similar infection patterns between 51833/wt and 51833/H274Y such that, one chicken inoculated with 51833/wt and three chickens inoculated with 51833/H274Y were AIV positive in oropharyngeal samples more than 2 days consecutively, indicating true infection, and one contact chicken exposed to infected mallards was AIV positive in faecal samples for 3 consecutive days (51833/wt) and another contact chicken for 4 consecutive days (51833/H274Y). Importantly, all positive samples from chickens infected with 51833/H274Y retained the NA-H274Y mutation. However, none of the virus strains established sustained transmission in chickens, likely due to insufficient adaptation to the chicken host. Our results demonstrate that an OC-resistant avian influenza virus can transmit from mallards and replicate in chickens. NA-H274Y does not constitute a barrier to interspecies transmission per se, as the resistant virus did not show reduced replicative capacity compared to the wild-type counterpart. Thus, responsible use of oseltamivir and surveillance for resistance development is warranted to limit the risk of an OC-resistant pandemic strain.

The health of influenza surveillance and pandemic preparedness in the wake of the COVID-19 pandemic.

The COVID-19 pandemic is the first to have emerged when Next Generation Sequencing was readily available and it has played the major role in following evolution of the causative agent, Severe Acute Respiratory Syndrome Coronavirus 2. Response to the pandemic was greatly facilitated though use of existing influenza surveillance networks: World Health Organization (WHO) Global Influenza Surveillance and Response System (GISRS), focussing largely on human influenza, and the OFFLU network of expertise on avian influenza established by the Food and Agricultural Organization of the United Nations (FAO) and the World Organization for Animal Health (WOAH). Data collection/deposition platforms associated with these networks, notably WHO's FluNet and the Global Initiative on Sharing All Influenza Data (GISAID) were/are being used intensely. Measures introduced to combat COVID-19 resulted in greatly decreased circulation of human seasonal influenza viruses for approximately 2 years, but circulation continued in the animal sector with an upsurge in the spread of highly pathogenic avian influenza subtype H5N1 with large numbers of wild bird deaths, culling of many poultry flocks and sporadic spill over into mammalian species, including humans, thereby increasing pandemic risk potential. While there are proposals/implementations to extend use of GISRS and GISAID to other infectious disease agents (e.g. Respiratory Syncytial Virus and Monkeypox), there is need to ensure that influenza surveillance is maintained and improved in both human and animal sectors in a sustainable manner to be truly prepared (early detection) for the next influenza pandemic.

Changed epidemiology of narcolepsy before, during, and after the 2009 H1N1 pandemic: a nationwide narcolepsy surveillance network study in mainland China, 1990-2017.

Increased incidence of narcolepsy was reported in children during the 2009 H1N1 pandemic following Pandemrix, a H1N1 flu vaccine. A link with A(H1N1) pdm09 infections remains controversial. Using nationwide surveillance data from China (1990 to 2017), the epidemiology of narcolepsy was analyzed. Individual records of narcolepsy patients were collected from 15 of 42 hospitals across China known to diagnose cases. Incidence was estimated assuming the representativeness of these hospitals. Age-specific incidence, epidemiological and clinical characteristics of patients were evaluated before, during, and after the 2009 H1N1 pandemic. Sensitivity analyses were conducted by including NT1 cases only and excluding the effect of the 2009 H1N1 vaccination. Average annual incidence was 0.79 per 100 000 person-years (PY) from 1990 to 2017 and 1.08 per 100 000 PY from 2003 to 2017. Incidence increased 4.17 (95% CI 4.12, 4.22) and 1.42 (95% CI 1.41, 1.44) fold during and after the 2009 H1N1 pandemic when compared to baseline. These results were robust in sensitivity analyses. Patients with the onset of narcolepsy during the pandemic period were younger (notably in 5-9-year-old strata), and the age shift toward younger children reversed to baseline following the pandemic. Increased incidence of narcolepsy was observed during the 2009 H1N1 pandemic period. This is likely to be associated with the circulation of the wild type A(H1N1)pdm09 virus. This observation should be considered for future influenza pandemic preparedness plans.

Insights into Genetic Characteristics and Virological Features of Endemic Avian Influenza A (H9N2) Viruses in Egypt from 2017-2021.

From 2010 to 2013, genotype I avian influenza A(H9N2) viruses of the G1-lineage were isolated from several poultry species in Egypt. In 2014, novel reassortant H9N2 viruses were detected in pigeons designated as genotype II. To monitor the subsequent genetic evolution of Egyptian A(H9N2) viruses, we characterized the full genomes of 173 viruses isolated through active surveillance from 2017 to 2022. In addition, we compared the virological characteristics and pathogenicity of representative viruses. Phylogenetic analysis of the HA indicated that all studied sequences from 2017–2021 were grouped into G1-like H9N2 viruses previously detected in Egypt. Phylogenetic analysis indicated that the Egyptian A(H9N2) viruses had undergone further reassortment, inheriting four genes (PB2, PB1, PA, NS) from genotype II, with their remaining segments deriving from genotype I viruses (these viruses designated as genotype III). Studying the virological features of the two most dominant genotypes (I and III) of Egyptian H9N2 viruses in vitro and in vivo indicated that both replicated well in mammalian cells, but did not show any clinical signs in chickens, ducks, and mice. Monitoring avian influenza viruses through surveillance programs and understanding the genetic and antigenic characteristics of circulating H9N2 viruses are essential for risk assessment and influenza pandemic preparedness.

Jordan's Pandemic Influenza Preparedness (PIP): A Reflection on COVID-19 Response.

The COVID-19 pandemic made it clear to the world that better preparedness for future pandemics is paramount. This study aims to explore how the 2018 Jordan’s Pandemic Influenza Preparedness (PIP) assessment plan (conducted utilizing a standardized tool of the CDC National Inventory of Core Capabilities for Pandemic Influenza Preparedness and Response) reflected on the initial COVID-19 response. A qualitative, single intrinsic case study design, utilizing interpretivist approach, was utilized to interview subject-matter experts and explore the potential reflection of PIP assessment on COVID-19 response. Utilizing a mini-Delphi approach, the interviews aimed at generating an in-depth understanding of how the Jordan’s PIP risk assessment reflects on the country’s response to COVID-19. The following 12 core capabilities, along with their reflections on COVID-19, were assessed: country planning, research and use of findings, communications, epidemiologic capability, laboratory capability, routine influenza surveillance, national respiratory disease surveillance, outbreak response, resources for containment, community-based interventions to prevent the spread of influenza, infection control (IC), and health sector pandemic response. Jordan’s experience and preparedness for influenza may have served as a crucial guide to establishing success in COVID-19 control and mitigation. Surveillance, outbreak, and research activities were very well established in Jordan’s PIP, whereas surge capacity in human capital and health facility were identified as two high-risk areas. However, the limitation in these two areas was met during the COVID-19 response. Still, human capital suffered fatigue, and there was an evident lack of laboratory testing plans when COVID-19 cases increased. Jordan’s experience with PIP may have served as a guide for establishing successful COVID-19 control and mitigation. The established PIP principles, systems, and capacities seem to have reflected well on fighting against COVID-19 in terms of more efficient utilization of available surveillance, laboratory, outbreak management, and risk communications. This reflection facilitated a better mitigation and control of COVID-19.

Striving for Health Equity: The Importance of Social Determinants of Health and Ethical Considerations in Pandemic Preparedness Planning.

Since the WHO’s “Influenza Pandemic Preparedness Plan” in 1999, pandemic preparedness plans at the international and national level have been constantly adapted with the common goal to respond early to outbreaks, identify risks, and outline promising interventions for pandemic containment. Two years into the COVID-19 pandemic, public health experts have started to reflect on the extent to which previous preparations have been helpful as well as on the gaps in pandemic preparedness planning. In the present commentary, we advocate for the inclusion of social and ethical factors in future pandemic planning—factors that have been insufficiently considered so far, although social determinants of infection risk and infectious disease severity contribute to aggravated social inequalities in health.

Kanta Subbarao—confronting influenza and COVID-19

Kanta Subbarao—confronting influenza and COVID-19

It's the Wrong Virus: Rapid Adaptation of Operations Inside a Highly Pathogenic Avian Influenza Select Agent Laboratory in Response to the 2019 SARS-CoV-2 Pandemic.

The Animal Biosafety Level 3 Enhanced (ABSL-3+) laboratory at St. Jude Children's Research Hospital has a long history of influenza pandemic preparedness. The emergence of SARS-CoV-2 and subsequent expansion into a pandemic has put new and unanticipated demands on laboratory operations since April 2020. Administrative changes, investigative methods requiring increased demand for inactivation and validation of sample removal, and the adoption of a new animal model into the space required all arms of our Biorisk Management System (BMS) to respond with speed and innovation. In this report, we describe the outcomes of three major operational changes that were implemented to adapt the ABSL-3+ select agent space into a multipathogen laboratory. First were administrative controls that were revised and developed with new Institutional Biosafety Committee protocols, laboratory space segregation, training of staff, and occupational health changes for potential exposure to SARS-CoV-2 inside the laboratory. Second were extensive inactivation and validation experiments performed for both highly pathogenic avian influenza and SARS-CoV-2 to meet the demands for sample removal to a lower biosafety level. Third was the establishment of a new caging system to house Syrian Golden hamsters for SARS-CoV-2 risk assessment modeling. The demands placed on biocontainment laboratories for response to SARS-CoV-2 has highlighted the importance of a robust BMS. In a relatively short time, the ABSL-3+ was able to adapt from a single select agent space to a multipathogen laboratory and expand our pandemic response capacity.

Leveraging International Influenza Surveillance Systems and Programs during the COVID-19 Pandemic

A network of global respiratory disease surveillance systems and partnerships has been built over decades as a direct response to the persistent threat of seasonal, zoonotic, and pandemic influenza. These efforts have been spearheaded by the World Health Organization, country ministries of health, the US Centers for Disease Control and Prevention, nongovernmental organizations, academic groups, and others. During the COVID-19 pandemic, the US Centers for Disease Control and Prevention worked closely with ministries of health in partner countries and the World Health Organization to leverage influenza surveillance systems and programs to respond to SARS-CoV-2 transmission. Countries used existing surveillance systems for severe acute respiratory infection and influenza-like illness, respiratory virus laboratory resources, pandemic influenza preparedness plans, and ongoing population-based influenza studies to track, study, and respond to SARS-CoV-2 infections. The incorporation of COVID-19 surveillance into existing influenza sentinel surveillance systems can support continued global surveillance for respiratory viruses with pandemic potential.

The Pandemic Influenza Preparedness Framework as a ‘specialized international access and benefit-sharing instrument’ under the Nagoya Protocol

The World Health Organization (WHO) is starting to come to terms with the public health implications of the United Nations’ Convention on Biological Diversity (CBD) and its supplementary Nagoya Protocol about genetic resource access and benefit-sharing (ABS). Since 2017 there have been calls to recognize the WHO’s Pandemic Influenza Preparedness (PIP) Framework as a specialized international ABS instrument under the Nagoya Protocol. This article will examine whether the PIP Framework meets the criteria of a specialized international ABS instrument as laid out in a 2018 study commissioned by the Subsidiary Body on Implementation to the CBD (CBD/SBI/2/INF/17). Our analysis concludes that while the PIP Framework meets the specialization criteria, it fails to meet the supportiveness criteria and does not provide legal certainty for pandemic influenza virus ABS. Furthermore, we demonstrate that recognition of the PIP Framework as a specialized instrument would not mean that the CBD and Nagoya Protocol no longer apply to influenza viruses with human pandemic potential as has been asserted, rendering the relationship between the three international agreements unclear. As the WHO grapples with how to regulate access to other (non-influenza) human pathogens and the fair and equitable sharing of benefits associated with their use, a full appreciation of what ABS means when applied to pathogens is essential.