Infectious Diseases - Q3 2021 by Mediaplanet UK&IE

Infectious Diseases Building a better European response system – lessons learnt from the COVID-19 pandemic In our globalised society, serious infectious health threats will eventually make their way across national borders. This underlines the importance of strong international cooperation with partners at EU and global level.

T Andrea Ammon Director, ECDC

hroughout the COVID-19 pandemic, the European Centre for Disease Prevention and Control (ECDC) has constantly assessed the evolving risk and advised EU/EEA member states on suitable response options. Based on data collected and lessons learned, we have delivered guidance to EU/EEA member states on most aspects of COVID-19, from infection prevention and control in hospitals to recommendations on the use of non-pharmaceutical interventions and vaccines. Investing in robust surveillance systems An important part of our pandemic response has been to collect, analyse and disseminate epidemiological data. During the pandemic, we have witnessed many member states’ challenges in establishing robust surveillance systems to deliver reliable, timely and comparable data on COVID-19. Initial delays in detecting ongoing community transmission in some countries led to widespread transmission before any mitigation measures could be taken, thus leading to a severe impact in several EU/ EEA countries during the spring of 2020. More recently, the lack of adequate, representative and integrated whole-genome sequencing data has contributed to the rapid spread of SARS-CoV-2 variants of concern. If high-performing surveillance systems had been in place, they would have informed more tailored and effective response measures, which in

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turn could have reduced the societal and economic impact of the pandemic. Lessons learnt from the pandemic We thus need to develop stronger, populationbased and fit-for-purpose surveillance systems that take advantage of new technologies and existing health data. Electronic health records are used in many European countries, but are not sufficiently standardised for their data to be used routinely. More effort also needs to be put into standardisation so that data can be comparable across countries. Tools such as mobile apps, where data is entered by members of the public, could also help detect outbreaks and monitor levels of community transmission of syndromes associated with pandemic threats. Another important lesson learnt is that preparedness and planning was not as robust, financed or as comprehensive as it needed to be. Strengthening public health systems and capacity building nationally and internationally is therefore key and must be seen as an investment and not a cost. This is true not only during pandemics, such as the current one, but also to tackle vaccine-preventable diseases and antimicrobial resistance. While it is not possible to predict exactly how future crises will play out, efforts should be focused on constructing frameworks that make our future response more effective and our health structures more resilient.

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SO MUST THE MEANS OF DETECTION Read more at www.globalcause.co.uk

How do we better prepare for future pandemics? With the world’s gaze focused on ramping up production and delivery of 11 billion safe and effective COVID-19 vaccine doses within a year, it is important that we turn an eye to the future.

Setting HIV testing targets to eliminate new diagnosis by 2030

Effective HIV treatment means people living with HIV have a normal life expectancy and can enjoy a healthy sex life knowing there is zero risk of passing HIV on to their partners.

s we need to make provisions for adequate contact tracing and access to diagnosis and treatment all around the world, disease surveillance and health system strengthening are key. What might be missed, however, is the necessary and swift sharing of pathogens with endemic, epidemic or pandemic potential, which is governed by an international agreement stemming from the Convention on Biological Diversity.

prevents sharing of samples and data on pathogens. If China had enacted and enforced legislation implementing the Nagoya Protocol, the sharing of SARS-CoV-2 could have been delayed and would have led to tremendous setbacks in a historical global response to the pandemic, in tracking, preventing and treating the disease.

Establishing a path toward pandemic preparedness We cannot simply hope that no country will apply the Nagoya Adding public health protection Protocol to withhold pathogen Coming into effect at the beginning data. It is too much of a risk and we of 2014, the Nagoya Protocol is a have already seen some countries legally-binding, supplementary engaging in such “pathogen international agreement to the diplomacy” with MERS, Ebola, 1992 Convention Zika and seasonal on Biological influenza over the Diversity (CBD). past decade. This agreement The devastating steers the fair and impact of COVID-19 If China had enacted equitable sharing and its various and enforced legislation of benefits when mutations further implementing the Nagoya spotlights the need genetic resources, including plants, for a multilateral, Protocol, the sharing of animals and legally binding SARS-CoV-2 could have micro-organisms, solution to ensure been delayed. are used across the scientific country borders. community Each country has a legal right to has access to pathogens for their genetic resources and can the development of vaccines, negotiate mutually agreed terms medicines and diagnostics. with other countries who wish to We must leverage our experiences use these resources. responding to this crisis to remove The challenge is that the obstacles for future generations implementation of the Nagoya facing public health emergencies. Protocol has unintended and Now, as ever before, is the time to undesirable consequences for come together to share pathogens global public health. Many in a timely, predictable way for countries have included pathogens, surveillance, epidemiology and such as poliovirus, Ebola virus, research purposes. coronaviruses or influenza viruses, in the scope of their access and benefit sharing legislation. Given that public health objectives are targeted at the Thomas Cueni eradication of pathogens and the Director, CBD is aimed at the protection General, IFPMA of biodiversity, this seems rather paradoxical, and potentially

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bout 6,000 people in England are unaware that they are living with HIV. Undiagnosed HIV drives onward transmission and late diagnosis, associated with worse health outcomes and significant health care costs. Routine HIV testing does more than reach the undiagnosed; a negative HIV test provides an opportunity to discuss and offer prevention strategies: regular testing, condom use, post-exposure prophylaxis (PEP) and preexposure prophylaxis (PrEP). These options, combined with treating diagnosed HIV, provide the tools to eliminate new HIV transmissions now, but this cannot be achieved without marked improvement in HIV testing. Therefore, the key message in the final report of the independent HIV Commission, established after the then Health Secretary’s pledge to end new cases of HIV in England by 2030, was ‘test, test, test!’

Routine HIV testing does more than reach the undiagnosed; a negative HIV test provides an opportunity to discuss and offer prevention strategies. Improving routine testing The HIV Commission’s recommendations are not new, but a renewed call to follow existing guidance from specialist societies and the National Institute of Health and Care Excellence (NICE). Routine emergency department and primary care testing in high

prevalence areas is not happening consistently, nor is routine testing in people with conditions indicative of a higher likelihood of HIV. Yet those of us working in the specialty cannot preach when too many people leave our own sexual health services without being offered an HIV test, adding to an already unacceptable catalogue of missed opportunities. Reducing the stigma Stigma is a major barrier to testing so we must educate, using materials written and distributed with input from affected communities. Also normalising HIV testing across healthcare, which could play a major role in reducing stigma, is an urgent priority. The incredibly high uptake yielded by opt-out antenatal HIV testing is testament to what normalised testing can achieve. We must ensure all health care workers are trained to offer testing non-judgementally, and pathways for managing reactive results and onward referrals are seamless, embedding HIV testing in all health sectors. The opportunity to eliminate new cases of a long-term condition is a rare one. We have the tools now but the first step to effective HIV treatment or prevention is to test, test, test. Laura Waters Consultant Physician HIV & Sexual Health, Central & North West London NHS Trust, Chair, British HIV Association

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How to help populations remain healthy Close collaboration between industry, governments and healthcare is crucial to fight back against the threat deadly infectious diseases are posing to the global population.

I Telma Lery European Therapeutic Area Lead - Infectious Diseases and Vaccines, Europe, Middle East and Africa, Janssen WRITTEN BY Mark Nicholls

IMR job code: CP-260400 Date of preparation: September 2021

nfectious diseases are a clear threat to mankind as they evolve, spread and disproportionately affect the most vulnerable. Of the top 10 causes of death worldwide, 30% are infectious diseases. That rises to 60% in developing countries. However, Telma Lery, European Therapeutic Area Lead - Infectious Diseases and Vaccines for Janssen, says there are actions that industry, government and healthcare professionals can take to fight back against this threat. Sustainable healthcare Immunisation is widely recognised as one of the world’s most successful and cost-effective health interventions, but well thought out public health policies, increased understanding of the modifiable risk factors and population lifestyle changes to make people less vulnerable to the effects of infectious diseases are also vital. “Minimising the transmission of infectious diseases is a core function of public health,” says Lery, who also underlined prevention as a key pillar for sustainable healthcare. “Its relevance is increasing as infectious diseases continue to spread more easily due to the trends of globalisation, population growth and aging, the development of megacities, climate change and increasing antimicrobial resistance.” Yet while the COVID-19 pandemic has created a major global public health crisis, there are numerous other ongoing conditions that need attention. Therapeutic and vaccine development Janssen, as the pharmaceutical companies of Johnson & Johnson, has a focus on discovering and developing novel therapeutics and vaccines to help prevent and treat infectious diseases. It has a long history in the area and has engaged in fighting disease and global pandemics for over a century from the 1918 flu pandemic through to developing a preventive solution to COVID-19. That has also included Ebola, which can rapidly spread to cause an outbreak; Human Immunodeficiency Virus (HIV), with some 37 million people affected globally, including 26 million in Africa; Respiratory Syncytial Virus (RSV); and Tuberculosis (TB), which still kills 1.4 million people each year, accounting for nearly one-third of all deaths from Antimicrobial Resistance (AMR). Johnson & Johnson also recently launched the J&J Satellite Center for Global Health Discovery at the London School of Hygiene & Tropical Medicine (LSHTM), to bring together expertise with a focus on advancing the development of next-generation drug regimens capable of treating all forms of TB.

Lessons from the past pandemics and outbreaks can help minimise the impact of a future public health crisis.

COVID-19 lessons Yet while vaccines remain one of the most effective methods of preventing life-threatening infectious diseases, Lery underlines the importance of supportive health facilities, infrastructure for rapid deployment of treatment, and controls to prevent ongoing spread of disease. In addition, steps must be taken to address stigma associated with some of these conditions, particularly for those living with HIV. A key lesson learned from COVID-19, and other pandemics, is the need for collaboration across different industries and governments to develop innovative solutions that help remove regulatory, research and development obstacles. That was illustrated during the Ebola epidemic in West Africa. Following the 2014 outbreak, which caused nearly 30,000 cases and more than 11,000 deaths, efforts to develop an Ebola vaccine were prioritised and accelerated. The Innovative Medicines Initiative (IMI) Ebola+ programme and the WHO Research and Development Blueprint initiative helped make way for the approval of the first vaccine from Merck in the European Union (EU) in 2019. This was closely followed by EU approval of Janssen’s Ebola vaccine regimen in 2020. To date, there are two approved vaccines for Ebola. In 2021, Ebola vaccines were swiftly deployed to frontline and healthcare workers in Sierra Leone in response to the outbreak in Guinea, contributing to efforts which prevented the outbreak from reaching the scale of levels seen in previous years. Global partnerships The rapid development of COVID-19 vaccines, and simultaneous scale-up of industry production capabilities, demonstrate the commitment of pharmaceutical companies in addressing global health crises and the strength of expert collaborations and global partnerships. These learnings can also shape future rapid response. She explains: “Lessons from the past pandemics and outbreaks can help minimise the impact of a future public health crisis. COVID-19 showed us the need to move fast when a new infectious threat is discovered.”

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Rapid diagnostic testing could help winter virus fight Rapid testing at the point of care could speed up identification of COVID-19 or other respiratory conditions this winter and help in slowing infectious disease spread.

C Gem McLuckie R&D Principal Scientist, Novacyt Group

WRITTEN BY Mark Nicholls

linicians and public health officials are braced for an increase in a range of respiratory conditions – as well as the ongoing COVID-19 threat – as winter approaches. Social distancing, masks and handwashing slowed the transmission of COVID-19, but also meant other conditions such as influenza or RSV (respiratory syncytial virus) were virtually non-existent, with limited immunity within the population. This underlines the need for rapid and effective diagnostic tests to determine whether an individual has COVID-19 or if it is another respiratory condition. Rapid testing Gem McLuckie, R&D Principal Scientist, with a background in public health, warns that the infectious respiratory disease situation will be significantly different this year as restrictions put in place to stop COVID-19, also stopped the spread of influenza and RSV. This has changed the dynamic; traditionally RSV would increase in winter, but as restrictions eased, there was evidence it was appearing before the winter season, she says. “Respiratory viruses present in similar ways, so we cannot really differentiate one respiratory virus from another by symptoms alone, so there is a big push toward testing,” says McLuckie, who is Principal Scientist with global diagnostic company Novacyt Group. “Increase in epidemiological testing is giving a better understanding of strains, but it is important to have

testing conducted quickly to determine the correct diagnostic pathway and treatment plans. Part of surge planning for RSV is this need for rapid diagnostic testing.” That has highlighted the need for new and novel ways to test quickly at point-of-care rather than sending samples to a central lab. Faster diagnostic testing Novacyt Group has devised a direct-PCR COVID-19 test, known as PROmate®, which avoids DNA isolation and purifications steps, and delivers a rapid diagnosis in under 80 minutes, meaning track, trace, isolation and treatment can begin sooner. “Having the answer closer, and quicker, means we are better placed to get diagnostic tests up and running, and at the required capacity” she says. Underlining the role of diagnostics in managing infectious diseases outbreaks is key. McLuckie believes the UK is well-placed to tackle COVID-19 and other respiratory conditions this winter with increased capacity, knowledge and testing capabilities. Novacyt Group has also established a genomic surveillance programme to validate the coverage of COVID-19 detection products against the most up to date sequence information. It has a dedicated team of bioinformaticians daily analysing this huge amount of data, to ensure its products can detect Variants of Concern and Variants under Investigation as well as emerging variants.

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Antimicrobial resistance is making our response to COVID-19 even harder As infectious diseases specialists, we have seen first-hand the devasting impact of the COVID-19 pandemic. We are also witnesses to the frightening by-products of this insidious virus.

I Emily Spivak MD, FIDSA Associate Professor of Medicine in Infectious Diseases, Medical Director of Antimicrobial Stewardship, University of Utah Health

f nothing else the pandemic has shown the importance of investments in prevention, public health and biomedical research and plainly demonstrated the growing threat of antimicrobial resistance. Reducing unnecessary antibiotic use that leads to antibiotic resistance and securing a healthy pipeline of novel antibiotics should be central to national and global efforts to strengthen our preparedness for future infectious diseases outbreaks. Shortage of antibiotics Unfortunately, current investments are failing to produce the critical antibiotics our patients need. Most large pharmaceutical companies have halted antibiotic research and development and small companies in the field struggle to remain afloat. In fact, in 2019, two small companies filed for bankruptcy despite launching new antibiotics — underscoring the need for a different approach to sustain antibiotic development. Misuse and overuse of antibiotics While fixing the pipeline is essential, a lack of drugs is only one piece of the antimicrobial resistance crisis. Excessive antibiotic use is responsible for accelerating the problem. Overuse and misuse of antibiotics is a significant problem that must be curtailed. Antibiotic stewardship programs in health care facilities have improved patient outcomes, reduced inappropriate antibiotic use and resistance and lowered health care costs. They are essential to our national