A Southampton-led UK study into the world's first plant-based COVID-19 vaccine has found it is 75% effective against the Delta variant. The new vaccine from Medicago and GSK reported positive results against all variants seen in the trial. The Omicron variant was not circulating during the study. Nearly 300 participants across 11 sites took part in the UK trial led by Southampton’s Dr Chrissie Jones. In total, around 24,000 adult volunteers were involved across six countries. No related serious adverse events were reported and reactions after vaccination were generally mild to moderate. Plant-based platform for new vaccines The Phase 3 placebo-controlled study assessed Medicago’s vaccine candidate in combination with GSK’s pandemic adjuvant, a vaccine ingredient used to create a stronger immune response. Dr Chrissie Jones, Associate Professor in Paediatric Infectious Diseases at University of Southampton, and Chief Investigator for the study said: “We are very grateful for the contributions of participants on the Medicago study, which have helped to identify another effective vaccine to help fight coronavirus. “The fact the vaccine candidate from Medicago and GSK is shown to produce a robust immune response is exciting news as this plant-based platform can produce new vaccines. This could help support countries around the world which are yet to vaccinate their population, as it may be easier to manufacture and scale up, aiding low- middle-income countries.” Developing Virus-Like Particles Medicago has been developing its plant-based technology for the past 20 years. The technique produces Virus-Like Particles (VLP) for its protein vaccines. VLPs are designed to mimic the native structure of viruses, allowing them to be easily recognised by the immune system. Because the VLPs lack core genetic material, they are non-infectious and unable to replicate. VLP vaccines developed by other technologies have traditionally been used worldwide for more than 30 years. Yosuke Kimura, Chief Scientific Officer at Medicago, said: “I am pleased to see our vaccine candidate moving forward and bringing to the world the first plant-based vaccine against COVID-19, diversifying the pool of vaccines available to help improve public health and protect more people.” The vaccine candidate is not approved yet by any regulatory authorities. Full results of the Phase 3 study will be released in a peer-reviewed publication as soon as possible. UK support for global vaccine The 293 participants recruited in the UK were vaccinated between April and June 2021. The trial took place while the UK vaccine rollout was taking place, which impacted on the final number of volunteers. The first participant in Europe was recruited at the Swansea Bay University Local Health Board site. Prof Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme, said: “We are pleased to see this latest vaccine study findings, which have been supported by research teams and volunteers across the UK. “The NIHR and our UK research community partners, along with the support of participants, continue to help to discover safe and effective vaccines to fight COVID-19. Positive study results such as this demonstrate that there is still a lot to learn and room for innovation within vaccine research.”

Professor Christopher Byrne is to be honoured with the Banting Memorial Lecture Award. The leader in metabolic medicine will deliver the prestigious lecture at next year’s Diabetes UK Professional Conference. The Banting Memorial Lecture is the highest award bestowed by Diabetes UK. It is awarded to a person internationally recognised for their contributions in the field of diabetes. Professor Byrne’s research focuses on diabetes and non-alcoholic fatty liver disease (NAFLD), also known as metabolic-associated fatty liver disease. In 2021, Professor Byrne was ranked fifth in the world and first in the UK for his NAFLD research over the last decade by Expertscape. The medical search service objectively ranks people and institutions by their expertise in biomedical areas. Professor Byrne is a Senior Investigator within the NIHR Southampton Biomedical Research Centre’s Nutrition, Lifestyle and Metabolism research theme. A platform for research The honour is high profile recognition of Professor Byrne’s outstanding contribution to diabetes research. Named Lectures are a central feature of Diabetes UK’s annual conference. They provide a platform for the most recent developments in research and progressive thinking about diabetes care. Professor Byrne, an Honorary Consultant Diabetologist & Metabolic Physician at University Hospital Southampton, said: “This prestigious award is a great honour for Southampton and for the many students, fellows and colleagues who have worked with me over 20 years. “The award is also a credit to the research participants, and the Southampton NIHR Clinical Research Facility and NIHR Biomedical Research Centre staff, without whose support, the research would not have been possible.” The Diabetes UK Professional Conference will take place across five days from 28 March to 1 April 2022. The majority of the conference will be an interactive virtual event, with one hybrid day including activities at the Queen Elizabeth II Centre, London. Research leadership in Southampton Professor Byrne was the Inaugural Director of the NIHR Southampton Clinical Research Facility. His pioneering research over the past three decades spans epidemiology to basic mechanisms and innovative clinical trials. His research leadership has been recognised by a number of prestigious awards. These include the Fournier Lipidology Award, British Hyperlipidaemia Association & Parke Davis/Pfizer Award and the Dorothy Hodgkin Award from Diabetes UK. Earlier this year, Professor Byrne described NAFLD and type 2 diabetes as a “vicious spiralling of worsening diseases”. Southampton BRC research in NAFLD is informing NHS guidelines, improving patient care and service delivery.

A new programme for young people in Southampton is helping teenagers discover how their lifestyle choices influence not only their own health but also the health of the planet. The LifeLab programme is bringing the arts and science together for the new initiative. Speakers from across the University of Southampton are running teenage workshops this winter. Working with Theatre for Life and environmentalists, the sessions explore the impact of climate change in our communities. The programme will examine themes such as air pollution, coastal erosion and habitat restoration. The insights are being related to the New Forest National Park, Weston Shore Beach and city of Southampton. The young people will work as a theatre company to devise, write and perform impactful theatre around the imminent climate crisis. Learning through LifeLab LifeLab is a unique educational programme created by the University of Southampton in collaboration with the NIHR Southampton Biomedical Research Centre and University Hospital Southampton (UHS). It engages young people with the science behind health messages and empowers them to take ownership of their own choices. The project has a purpose-built education facility in UHS with state-of-the-art equipment and a dedicated team of educators. The new programme stems from LifeLab’s work with secondary schools before the pandemic, looking at how lifestyle choices affect the environment. Through the Cultivate! project, young people had the opportunity to take part in activities such as an escape room. These helped them consider what changes to their own lifestyles would positively impact the world around them. This was developed into a programme for primary schools to help children think about their food choices as they transition to secondary school, considering the health factors and sustainability of what they eat. Making positive changes The new arts and science programme launched in November. It included an interactive workshop in University greenhouses with Dr Mark Chapman of Biological Sciences. A future session will build understanding in developing policy around climate change with the Head of University’s Public Policy Unit. LifeLab programme lead Dr Kath Woods-Townsend said: “Climate change is front and centre of the agenda, particularly for young people, so enhancing their understanding of how they can directly impact the health of their planet as well as their own is a fascinating new direction for us. “We are excited to see how the partnership with Theatre for Life can combine the arts and science in a new way of engaging young people in making positive changes.” Michelle Smith, Artistic Director for Theatre for Life, added: “The collaborative nature of this project is enabling all the organisations involved to use science, art and culture as a platform to influence and lead public engagement on climate and the environment. “It will create a legacy and sustainability beyond the project and provide a tool for social change." The new programme is funded by the University’s Public Engagement with Research unit (PERu).

Southampton researchers have revealed one reason why COVID-19 patients on ventilators have trouble breathing, and how refining a treatment could help save lives. The COVID-19 virus latches onto cells deep in our lungs that produce surfactant – a complex mixture which lines our lungs’ air sacs and is essential for breathing. A Southampton research team, led by Dr Ahilanandan Dushianthan, Professor Mike Grocott, Professor Tony Postle and Professor Howard Clark (UCL) has shown COVID-19 patients on ventilators had less surfactant, and discovered why giving extra surfactant doesn’t always work. They suggest that, by giving surfactant for longer, more intensive care patients could survive. Why is surfactant important? Surfactant helps to reduce the surface tension of water that lines the air sacs of the lungs, making it easier to breathe. It was first found to be important in premature babies, who have less surfactant when they are born. This can lead to a condition known as Infant Respiratory Distress Syndrome, which is routinely treated successfully by given artificial surfactant to top up their surfactant levels and help them breathe more easily. A similar condition in adults, known as Adult Respiratory Distress Syndrome (ARDS), affects critically ill patients with severe COVID-19. Rapid turnover of surfactant This new pilot study, showed that 10 COVID-19 patients with ARDS who were on ventilators at University Hospitals Southampton or University College London Hospital had less surfactant than healthy people. The investigators gave the patients Alveofact, a surfactant often used to treat premature babies, as a fine mist into their lungs, and studied how the composition of the surfactant changed. Surfactant is naturally absorbed and replaced by the body over time. But their results, published in the American Journal of Respiratory and Critical Care Medicine, show a particularly rapid turnover of the artificial surfactant. It is the first study to show this in COVID-19 patients. This rapid turnover could explain why the benefits of giving replacement surfactant only last for a short while. Giving it for a longer period, they suggest, could help save lives. Dr Dushianthan, a Consultant in General Intensive Care at University Hospital Southampton, said: “This has very significant implications for the design of future treatments for severe COVID-19. We found that replacement surfactant rapidly cleared with a half-life of about seven hours. This indicates that multiple surfactant doses over a number of days will be required to support breathing while the lung cells repair after the infection passes.” The clinical trial was a collaboration between the University of Southampton and University College London. It has been funded by the Bill & Melinda Gates Foundation.

Exercise improves asthma symptoms and reduces lung inflammation, but until now it has not been clear how it does this. New research reveals it protects cells by boosting their natural defences. Southampton researchers, led by Prof Tom Wilkinson, have shown how women with asthma had better symptoms, quality of life and lung function after an exercise programme. They combined this with tests that showed how changes in their cells and blood led to these improvements. The results are published in the journal Antioxidants. The study in the NIHR Southampton Biomedical Research Centre formed part of Dr Anna Freeman’s research for her PhD. Protecting cells We need oxygen to survive, but using it produces ‘reactive oxygen species’ (ROS) which can damage our cells. To cope with this, our cells have in-built defences to prevent them from building up. Eating a healthy diet, rich in antioxidants like vitamin C, helps protect our cells. So too does exercise. Exercise as medicine Six women with asthma followed a specially developed 12-week exercise programme, alongside a clinical assessment of their asthma and tests to measure how effectively their bodies processed ROS. After completing the programme, the researchers found the women were not only fitter, but also that their asthma symptoms, quality of life and lung function were better. They also showed a reduction in ‘eosinophilic inflammation’ – lung inflammation caused by a type of white blood cell malfunctioning, which occurs in some types of asthma. Developing resilience Participants who were fittest at the end of the programme also had the greatest improvements in the antioxidant capacity in their blood. The researchers therefore suggest that exercise could improve asthma symptoms by improving the regulation of ROS. In this way, exercise builds resilience and can help people manage their condition. Dr Freeman, NIHR Academic Clinical Lecturer in Respiratory Medicine, said: “This study shows exercise can be an important way for people with asthma to manage their symptoms. But it goes further than this – providing a more detailed understanding of the underlying reasons for why it is so beneficial. “We now intend to go on to study this in a larger group of people, across multiple sites.”

Southampton researchers have joined calls for the appointment of a Cabinet Minister for Children. Professors Keith Godfrey, Mark Hanson and Dr Chandni Maria Jacob have contributed to a new report that advises the Government to better prepare the future adult generation who will inherit the post-pandemic world. The Physical Health of Children and Young People report is the second of four documents coordinated by The Children’s Alliance. It sets out a practical plan for action to reverse what it calls a serious decline in health and wellbeing of children and young people. The three University of Southampton researchers are part of the opening two chapters of report. These discuss how the early years of a person’s life are instrumental in determining their future risk of non-communicable diseases. The chapters also highlight the importance of nutrition during preconception, pregnancy and infancy. They show that these impact children’s physical development and have major consequences for their lifelong health. Calls for new Cabinet Minister The report shows that some groups of children and young people are disadvantaged by their family grouping, geographical, cultural or socioeconomic circumstances. It says a new Cabinet Minister for Children would make that a focus in all government departments. Some of the key recommendations include: · A preconception health strategy to be fully integrated into primary healthcare and raised in routine discussion during visits to clinicians · Preconception health to be a statutory national school curriculum requirement · A ‘family first’ as opposed to ‘children’s diet’ approach to be advocated by health and childcare professionals · Re-positioning strategy to promote and encourage lifelong physical activity so that it is not presented solely/predominantly through a medical or ‘deficit’ lens Professor Keith Godfrey, Theme Lead for Nutrition, Lifestyle and Metabolism in the NIHR Southampton BRC, said: “The health and wellbeing of our children and young people is in serious decline, exacerbated by the COVID-19 pandemic. Effective co-ordinated measures led by Government are an urgent priority. “As set out in today’s report, one of key measures must be a new focus on preconception health for the benefit of the next generation – this needs to include education about health and wellbeing before pregnancy and parenthood as a statutory national school curriculum requirement.” New need for ‘co-ordinated measures’ Some authors of the report say that national focus on children’s physical health has become too preoccupied with weight management and addressing rising levels of obesity. Baroness Frances D’Souza, The Honorary President of The Children’s Alliance, said: “Physical Health is a comprehensive study of children’s physical health during the time of COVID-19. It features the work of 37 nationally-renowned specialists in children’s health, and it is published during the ‘festive season’ when children are traditionally bombarded by advertised food and drink ‘treats’ – to be succeeded by yet more ineffective measures narrowly focussed on ‘fighting the flab’ by calorie counting and step counting. “Without effective co-ordinated measures led by Government, we run the risk that the next generation of UK adults will be the least healthy in living memory.”

People treated in hospital with COVID-19 who remained unwell at five months show limited further recovery after one year, according to the latest results of a national study. Patients were less likely to fully recover if they were female, obese and required invasive mechanical ventilation (IMV) to support their breathing during their hospital stay. The PHOSP-COVID study assessed 2,230 adults who had been hospitalised with COVID-19 across UK sites including Southampton. Over a third have now completed five-month and 12-month assessments. Researchers found that one year after leaving hospital, less than three in 10 patients reported they felt fully recovered. This was largely unchanged from 2.5 in 10 at five months. The most common ongoing symptoms were fatigue, muscle pain, physically slowing down, poor sleep and breathlessness. Measuring recovery The study, led by the NIHR Leicester Biomedical Research Centre, involved researchers from 53 institutions and 83 hospitals across the UK. Recovery was measured using patient-reported data, physical performance and organ function tests. The study is now available as a pre-print, which means it is yet to be checked by other scientists. Dr Mark Jones, Associate Professor in Respiratory Medicine at the University of Southampton and Local Principal Investigator, said: “The PHOSP-COVID study has identified persistent long term health effects in many patients who required treatment in hospital for COVID-19. It is now beginning to investigate the reasons underlying these persistent effects. Such understanding is essential if we are to develop better ways to help this patient group.” To date, the research team in Southampton has recruited almost 140 patients. This has been made possible by huge efforts in the NIHR Southampton Biomedical Research Centre and the NIHR Southampton Clinical Research Facility. Urgent need for new medicines Over half a million people in the UK have been admitted to hospital as a result of COVID-19. Researchers warn that a sizeable population are at risk of persistent ill-health and reduced quality of life. Dr Rachael Evans, an Associate Professor at the University of Leicester and a lead author of the paper, said: “We urgently need healthcare packages and medicines that target the potentially treatable traits of Long-COVID to help people feel better and get back to their normal lives. Without these, Long-COVID has the potential to become highly prevalent as a new long-term condition.” Professor Louise Wain, GSK-BLF Chair in Respiratory Research at the University of Leicester and a lead author of the paper, said: “The good news is that we have identified some differences in the blood samples of those who are still experiencing the long-term physical and cognitive effects of their COVID-19 hospital admission. These differences give us clues about the potential underlying mechanisms and suggest that we may be able to use existing medicines that target these mechanisms to help these subgroups of patients.” The PHOSP-COVID study was jointly funded by the NIHR and MRC-UK Research and Innovation (UKRI).

Southampton researchers have found that the link between smoking at the start of pregnancy and having a smaller baby may extend to future pregnancies. The findings showed that women who smoked at the start of their first pregnancy were more likely to have a baby born smaller than expected in their second pregnancy compared to non-smokers. This was even the case where they reported quitting by the start of their second pregnancy. The research from the University of Southampton and University Hospital Southampton Foundation Trust has been published in the scientific journal PLOS One. Extending evidence for following pregnancies The biological relationship between smoking during pregnancy and baby’s birth weight from the same pregnancy is well established. However, until now there has been limited evidence on the impact of maternal smoking on following pregnancies. In this study, the researchers found that for women who did not smoke at the start of either pregnancy, there was no extra risk of a small for gestational age (SGA) baby in the second pregnancy compared to non-smokers, even if they smoked between pregnancies. A mother who smoked ten or more cigarettes a day at the start of both of her first two pregnancies had the highest odds of SGA birth. Dr Nisreen Alwan, Associate Professor in Public Health at the University of Southampton, who led the study, said: “It is important to encourage women to quit smoking before pregnancy and to not resume smoking after the baby is born. Resources that support mothers to quit and maintain smoking cessation are needed.” Elizabeth Taylor, Postgraduate Research Assistant at the University and first author of the study, said: “Women who smoke between pregnancies can reduce the risk of having a SGA baby by stopping smoking before the start of their next pregnancy. The period between pregnancies is when most mothers have close contact with health and care professionals and may require support to stop smoking.” Examining Southampton data The research team studied data between 2003 and 2018 for nearly 17,000 mothers who received antenatal care for their first two pregnancies. The study covered women who lived in Southampton and surrounding parts of Hampshire. The research was supported by research grants from the Academy of Medical Sciences, Wellcome Trust and the National Institute for Health Research (NIHR) Southampton Biomedical Research Centre. It is hoped that these findings and future research will encourage healthcare professionals and commissioners to provide better support to women before and between pregnancies, helping them to quit smoking, leading to better health for both mothers and children.

Southampton is set to collaborate on a study of brain function in long COVID. Led by University College London (UCL), it's one of 15 announced in a £19.6 million funding push to tackle long COVID. A growing problem In long COVID, symptoms are wide-ranging and fluctuating. They can include breathlessness, chronic fatigue, “brain fog”, anxiety and stress. Yet little is understood about how long COVID occurs, or the best ways of managing it. With people continuing to develop COVID-19, the number of people affected is expected to grow. That's the reason behind a £19.6 million National Institute for Health Research (NIHR) Long COVID research fund which has recently announced funding for 15 studies. Each aims to advance our understanding of Long COVID and appropriate treatments. Tackling cognitive issues One of those studies (CICERO), led by UCL, aims to help the estimated 25-75% of those with long COVID who have ‘cognitive impairment’. This means they have trouble remembering, learning new things, concentrating or making decisions. As a result, many find it hard to return to work. Prof. Chris Kipps, consultant neurologist and associate medical director for research and development at University Hospital Southampton, is leading Southampton’s involvement together with the Trust’s neuropsychology department. Investigating long COVID’s effects on the brain Cognitive tests and MRI scans will be used to study the extent and types of cognitive impairment. Links with symptoms like fatigue, anxiety, depression and poor sleep will also be explored. Those data will drive work assessing rehabilitation methods for those with long COVID. Results here will identify effective approaches to restoring cognitive function, faster. They will also inform a “Covid-19 Cognitive Recovery Guide” for those affected, their family, friends and GP. It's hoped that combing the guide with proven rehabilitation methods will see people regain normal life, faster. “Tackling long COVID is going to be a big challenge,” said Prof. Chris Kipps. “This study will help reveal what’s really going on in the brain of long COVID patients with cognitive impairment. And once we have that we can begin to find ways to treat it to help people return to their normal lives.”

Over 200 people from Southampton joined the national COV-BOOST study. That makes the city one of the biggest contributors to this vital study, looking at ways of using coronavirus booster jabs. Those people are part of 2,886 volunteers nationwide. Taking part at 16 different sites, they joined through the national NHS COVID-19 Vaccine Research Registry. All are adults aged 30 years or more, who received their first two vaccinations early on. They include adults over 75 years of age and health and care workers. "We needed people aged 30 and over, who’d received their first two vaccinations early on. In practice that meant Southampton's older people and frontline workers. Their response was fantastic. Yet again the people of Southampton have stepped up, meaning we can get the answers faster," comments Prof Saul Faust, Chief Investigator and Director of NIHR Southampton Clinical Research Facility. The study was the first trial worldwide set up to compare different booster vaccines. In the UK, the data will inform advice from the Joint Committee on Vaccination and Immunisation (JCVI) regarding which vaccines will be used in the NHS booster programme from September. It's hoped the results will help to optimise protection for the most vulnerable through the winter period. Trialling seven vaccines as potential boosters The trial will look at seven different COVID-19 vaccines including 3 at half the standard dose: Oxford/AstraZeneca Pfizer/BioNTech Moderna Novavax Valneva Janssen CureVac The third jab will fall at least 10 to 12 weeks after participants' second doses. That booster may not use the same vaccine as their first two jabs. All participants will be monitored throughout the study for any potential side effects. They will also have bloods taken to measure their immune responses at days 28, 84, 308 and 365. A small number will have extra blood tests at other times. A symptom app allows participants to alert the study team if needed and 24-hour emergency phone access to a study doctor. Those interested can find out more on Twitter @CovBoost and the website covboost.org.uk.

Southampton has contributed to new research into extremely rare blood clots appearing after COVID-19 vaccination. The findings point the way to better treatments for those affected. Most people who have the COVID-19 vaccine experience no serious side effects. However, 1.4 people per 100,000 experience vaccine-induced immune thrombotic thrombocytopenia (VITT). VITT can lead to abnormal blood clot formation, blocking blood vessels in the brain. This cerebral venous sinus thrombosis (CVST) results in stroke - bleeding and swelling in the brain. It also drives a drop in blood platelets levels. Platelets are key to stopping bleeding and less of them means brain bleeds can be more severe. Findings support treatment choices Southampton consultant and physician, Dr Richard Marigold collaborated on this landmark study. Led by University College Hospital London, the results were published in The Lancet. The study team compared outcomes of 70 patients with VITT-associated CVST with 25 patients with non-VITT CVST. They found VITT-associated CVST resulted in higher rates of death, or dependency on others after discharge. Yet they also showed treatment choice could change this. Death or dependency rates were lower for VITT-CVST patients who had received either immunoglobulin or non-heparin anti-clotting drugs. Immunoglobulin is a mix of antibodies that modify the body’s immune response – a key part of stroke-induced injury. Dr Marigold said: “The data supports this rare condition being treated with non-heparin blood thinning medication and intravenous immunoglobulin, reducing mortality and increasing the chances of patients returning home to independent living “However, we would urge caution in interpreting this observational data as it is not a randomised controlled trial, and more studies are needed to establish how effective the medications are. Further research is required to explain the underlying mechanisms causing this reaction to prevent it happening and improve future vaccine design. In addition, clinicians need to be aware of the early markers of this condition, as without recognition and prompt treatment, the outcome can be poor.” Not a reason to avoid COVID-19 vaccination Although VITT-associated CVST has severe impacts, it is extremely rare. Professor Saul Faust, Director of the NIHR Southampton Clinical Research Facility and lead for COVID-19 vaccine studies at UHS, comments: “Studies such as this, alongside the national MHRA and public health surveillance systems for medicines and vaccines side effects, are key to ensuring those with rare side effects are identified and the mechanisms and potential treatments understood. However, it is vital to view these results in context, as VITT is incredibly rare. It is also worth bearing in mind that, in age groups offered the AstraZeneca vaccine, COVID-19 infection itself can cause blood clotting problems. “Vaccination is critical to protecting us all, the NHS and to stemming the emergence of new – potentially more lethal – variants. The vaccines in use passed through rigorous trials and continue to be monitored for safety and side-effects. What this study shows is that colleagues across the NHS are acting fast to understand and tackle such issues when they do arise.” Dr Richard Perry, lead author and Consultant Neurologist at the National Hospital for Neurology and Neurosurgery at University College Hospital London said: “With an illness of such severity, often in young patients who were previously fit and well, doctors have been desperate for evidence regarding treatments that might prevent some of the death and disability that arises from this condition. “While an observational study is not the ideal platform to provide evidence for which medications work, it may be a long time before we have evidence from randomised clinical trials, the gold standard for testing new treatments. For the moment we are dependent on observational studies like CAIAC for our evidence.”

Lab tests have shown a promising antiviral treatment to be effective against the Alpha and Beta COVID-19 variants. Southampton-led research into a COVID-19 treatment is set to continue after promising new results. These data show that inhaled interferon beta (IFN-beta) is effective against new variants in the lab. The treatment is being developed by University of Southampton spin-out company Synairgen. It delivers a fine mist of the protein IFN-beta breathed deep into the lungs. Interferon beta is a naturally occurring molecule, key to our airways' anti-viral defences. By adding extra IFN-beta straight to the lungs, the Synaurgen treatment boost those defences. Data showing coronavirus limits IFN-beta levels adds weight to this approach in COVID-19. The drug is currently in large scale trials, after early trials showing it improved patients' odds of avoiding intensive care by up to 80%. Led Professor Tom Wilkinson, those trials in hospitalised COVID-19 patients have now opened in India. Highly effective against two variants New variants of the Sars-Cov2 could be different enough to limit how well COVID-19 treatments work. That would set doctors, and society back in the fight to contain pandemic impacts. The latest tests were vital to understand the impact of new variants on the Synairgen treatment. Scientists at Viroclinics-DDL in the Netherlands, conducted the tests of Synairgen’s IFN-beta. They applied doses equal to those in treated patients' lungs to cells infected with either Alpha (UK/Kent) or Beta (South African) variants. That treatment reduced the amount of virus in both groups to undetectable levels. Continuing international trials These data are good news for the ongoing phase III international trial of inhaled IFN-beta. That trial involves more than 600 patients in 20 countries. It follows early phase results showing patients had up to 80% lower chance of needing intensive care, and better recovery. If successful, the researchers hope for approval later in the summer. “Emerging variants of SARS-CoV-2 are of great concern as they may negatively impact on the effectiveness of current vaccines and therapeutics," comments Prof Sir Stephen Holgate CBE, Medical Research Council Clinical Professor of Immunopharmacology at the University of Southampton and Co-Founder of Synairgen. “These data are not surprising, and confirm the broad-spectrum antiviral activity of SNG001, which has shown activity against a range of respiratory viruses such as RSV, rhinovirus, adenovirus and influenza, and reassuringly confirm its activity against these SARS-CoV-2 variants, which is important in the context of our ongoing Phase III trial in hospitalised patients and the future use of this drug against SARS-CoV-2 and other emerging viral threats.” Richard Marsden, CEO of Synairgen, added: “As expected, these data confirm that SNG001 is a broad-spectrum antiviral product, now also demonstrating applicability against SARS-CoV-2 variants. The SARS-CoV-2 virus suppresses the production of the essential antiviral protein IFN-beta to evade the host immune system; it is therefore to be expected that when IFN-beta is reintroduced into an infection experiment that the host cells are able to repel the virus. “Alongside vaccines, our lines of defence for this pandemic and future outbreaks rely in part on access to effective antivirals with broad-spectrum activity against a range of viruses and variants. The current focus on the Indian variant demonstrates how concerned Governments are about the risk that a variant may render the vaccines less effective, and we are pleased to see initiatives being put in place to accelerate and support development of antiviral therapeutics as a backstop for patients who are admitted to hospital. We are pleased to report that we have now started dosing patients at trial sites in India in our Phase III study."