Latest news with #CSLSeqirus
West Australian
14-05-2025
- Health
- West Australian
Australia's sole Q Fever vaccine provider confirms it is prepared to combat the country's rising case numbers
Australia's sole Q Fever vaccine provider says the serious bacterial infection vaccine is no longer in short supply, quelling fears the farming industry would not be able to combat rising case numbers across the country. Concerns arose after Cattle Australia called for an urgent $3 million cash injection to bring a new Q Fever vaccine to market on April 29. CSL Seqirus — manufacturer of the Q-VAX vaccine in Melbourne — confirmed with the Countryman current supply levels would meet current demand. The zoonotic disease is transmitted predominantly from goats, sheep and cattle and is caused by the bacterium Coxiella burnetii. It is released through faeces, urine, milk and birth products from infected animals but can spread through the air and dust. Most people in Australia are unaware of the disease and its potential consequences, including flu-like symptoms, pneumonia and hepatitis. Victoria experienced five notified outbreaks between August and December last year, with a total of 77 notified cases — more than double the State's average annual incident of the past five years. This year alone, six cases have been reported to WA Health, while 16 cases were reported in 2024 — spiking in the back end of the year. The yearly average is eight in Western Australia. A CSL Seqirus spokesperson said 'normal supply' for the Q-VAX vaccine resumed in February, following a period of limited supply where stock was managed centrally to ensure access for people at the highest risk of infection. 'Approximately 30 to 40,000 Australians are vaccinated against Q fever annually and this is typically driven by workplace vaccinations, public health campaigns and outbreaks of disease,' they said. 'We have been working closely with local Public Health Units in regions with outbreaks to ensure access to vaccination. 'There is always the potential for small increases in demand due to outbreaks and our annual supply planning takes this into account.' They said a new 'world-class' manufacturing facility near Melbourne Airport is due for completion in 2026 which will manufacture vaccines and antivenoms for Australia and the world. There are more than 80 clinics offering Q fever vaccinations across the State.
Telegraph
07-05-2025
- Business
- Telegraph
EU shores up pandemic defences with 478m flu vaccine deal
The European Union has snapped up advanced manufacturing capacity for at least 478 million doses of pandemic flu vaccine, surging ahead in the race to prepare for a possible bird flu outbreak in humans. According to data from the health analytics firm Airfinity, the EU now has signed agreements with seven manufacturers to reserve vaccines – including a new deal unveiled last week with CSL Seqirus for a further 27m doses. Although governments including Canada and the UK have reserved more doses per person, the EU has the largest and most diverse supply chain for a possible influenza pandemic. As reported in the Lancet last week, the recent emergence of highly pathogenic H5N1 avian influenza virus infections in dairy cows and humans in the US has 'raised alarms regarding the potential for a pandemic'. 'Over 995 dairy cow herds and at least 70 humans have been affected, including cases of severe disease and the first reported H5N1-related death in the U.S'. This emerging threat has caused health authorities across the globe to quietly start planning for a possible spillover to humans, with a clear focus on vaccine supply. The shots the EU now has on standby do not constitute a stockpile. Rather than amassing a store of ready-to-use vaccines which protect against known strains of bird flu, the bloc has bet big on reserving access to outbreak-specific shots. These would be produced after a pandemic was declared and the exact strain of the virus was known – giving the best chance of the jabs being efficacious in humans. Richard Bennett, lead analyst at Airfinity, said the EU was also hedging its bets by doing deals with seven different firms. 'This diversification reduces the risk of supply disruption if one manufacturer encounters production issues, and prevents monopolising capacity from any single supplier,' he said. Other countries have also set about reserving access to as-yet-unmade vaccines. Germany has secured production capacity or 400 million doses, under a framework that would also distribute manufactured jabs to the wider European Union. Vaccine resilience and flexibility Meanwhile the UK and Canada have reserved 100m and 80m doses respectively. Although this equates to more shots per person than the EU has access to (1.5 per capita for Britain, two for Canada and one for the EU), the supply chains are less diverse. Canada is reliant on GSK, while the UK has a single deal with CSL Seqirus, according to Airfinity. Unlike the other countries included in the analysis, the US does not have enough doses to cover its entire population. Mr Bennet said this is unsurprising, 'given previous [US] demand for pandemic vaccines'. During the H1N1 'swine flu' outbreak in 2009, national vaccine coverage was just 27 per cent, though this jumped to 69.5 per cent during the coronavirus pandemic. Still, the superpower has 250m doses of pandemic flu shots reserved with CSL Seqirus and Sanofi, plus a stockpile of 20m shots against known strains of bird flu already circulating. 'Most countries depend on a handful of manufacturers for pandemic flu vaccines. Seven companies produce over 85 per of global supply, leaving national stockpiles vulnerable to geopolitical tensions, production delays, or supply chain shocks,' the Airfinity analysis warned. 'The EU has reduced reliance on single suppliers by securing contracts with multiple manufacturers, creating a more resilient and flexible vaccine procurement strategy during emergencies.' Production delays and vaccine nationalism The coronavirus pandemic highlighted the threat of vaccine nationalism, production delays and export restrictions. India's export bans, for instance, stalled the rollout of shots from Covax, which sought to buy immunisations for developing countries. The US also imposed limits on the export of vaccines and the critical equipment and materials needed to make them, while the EU threatened to block the export of AstraZeneca shots made for the UK government in the Netherlands. Ray Longstaff, director for Pandemic and Outbreak Preparedness and Response at CSL Seqirus, said the company has designed its manufacturing network and contracts to ensure minimum disruption in the face of these sorts of threats. 'In our agreements, we have supplied safeguards and comprehensive information about how we will not only meet the timelines … but also the kind of preparedness measures that we put in place to protect supply chains,' he said. 'It's something that we take very seriously.' The company – which has manufacturing sites in the UK, US and Australia – is one of the world's largest producers of seasonal flu shots. It also has a bird flu vaccine programme, plus a separate initiative to create pandemic-specific vaccines. If the WHO declared a pandemic, all manufacturing would switch to solely respond to the given outbreak. The pharmaceutical firm's latest deal reserves 27.5m pandemic flu doses for 17 participating EU member states, which would be manufactured at the CSL Seqirus site in Liverpool using an egg-based production method. The company now has deals to supply pandemic shots to more than 30 governments worldwide, including the UK. Mr Longstaff said he could not discuss specifics of the contracts – which include reservation fees that are invested in 'maintaining readiness and preparedness' – and downplayed the ramifications of potential tensions between governments in a pandemic scenario. He also stressed that the company would support lower income countries through the WHO's Pandemic Influenza Preparedness (PIP) framework. Agreed after the 2009 swine flu outbreak, this requires companies to donate 10 per cent of their pandemic influenza shots, in real time. This principle has also been incorporated into the new WHO pandemic treaty, set to be approved at the World Health Assembly in Geneva later this month, in an attempt to ensure that wealthy countries are not the only ones who have access to medical countermeasures in the event of an outbreak.
Yahoo
07-05-2025
- Business
- Yahoo
EU shores up pandemic defences with 478m flu vaccine deal
The European Union has snapped up advanced manufacturing capacity for at least 478 million doses of pandemic flu vaccine, surging ahead in the race to prepare for a possible bird flu outbreak in humans. According to data from the health analytics firm Airfinity, the EU now has signed agreements with seven manufacturers to reserve vaccines – including a new deal unveiled last week with CSL Seqirus for a further 27m doses. Although governments including Canada and the UK have reserved more doses per person, the EU has the largest and most diverse supply chain for a possible influenza pandemic. As reported in the Lancet last week, the recent emergence of highly pathogenic H5N1 avian influenza virus infections in dairy cows and humans in the US has 'raised alarms regarding the potential for a pandemic'. 'Over 995 dairy cow herds and at least 70 humans have been affected, including cases of severe disease and the first reported H5N1-related death in the U.S'. This emerging threat has caused health authorities across the globe to quietly start planning for a possible spillover to humans, with a clear focus on vaccine supply. The shots the EU now has on standby do not constitute a stockpile. Rather than amassing a store of ready-to-use vaccines which protect against known strains of bird flu, the bloc has bet big on reserving access to outbreak-specific shots. These would be produced after a pandemic was declared and the exact strain of the virus was known – giving the best chance of the jabs being efficacious in humans. Richard Bennett, lead analyst at Airfinity, said the EU was also hedging its bets by doing deals with seven different firms. 'This diversification reduces the risk of supply disruption if one manufacturer encounters production issues, and prevents monopolising capacity from any single supplier,' he said. Other countries have also set about reserving access to as-yet-unmade vaccines. Germany has secured production capacity or 400 million doses, under a framework that would also distribute manufactured jabs to the wider European Union. Vaccine resilience and flexibility Meanwhile the UK and Canada have reserved 100m and 80m doses respectively. Although this equates to more shots per person than the EU has access to (1.5 per capita for Britain, two for Canada and one for the EU), the supply chains are less diverse. Canada is reliant on GSK, while the UK has a single deal with CSL Seqirus, according to Airfinity. Unlike the other countries included in the analysis, the US does not have enough doses to cover its entire population. Mr Bennet said this is unsurprising, 'given previous [US] demand for pandemic vaccines'. During the H1N1 'swine flu' outbreak in 2009, national vaccine coverage was just 27 per cent, though this jumped to 69.5 per cent during the coronavirus pandemic. Still, the superpower has 250m doses of pandemic flu shots reserved with CSL Seqirus and Sanofi, plus a stockpile of 20m shots against known strains of bird flu already circulating. 'Most countries depend on a handful of manufacturers for pandemic flu vaccines. Seven companies produce over 85 per of global supply, leaving national stockpiles vulnerable to geopolitical tensions, production delays, or supply chain shocks,' the Airfinity analysis warned. 'The EU has reduced reliance on single suppliers by securing contracts with multiple manufacturers, creating a more resilient and flexible vaccine procurement strategy during emergencies.' Production delays and vaccine nationalism The coronavirus pandemic highlighted the threat of vaccine nationalism, production delays and export restrictions. India's export bans, for instance, stalled the rollout of shots from Covax, which sought to buy immunisations for developing countries. The US also imposed limits on the export of vaccines and the critical equipment and materials needed to make them, while the EU threatened to block the export of AstraZeneca shots made for the UK government in the Netherlands. Ray Longstaff, director for Pandemic and Outbreak Preparedness and Response at CSL Seqirus, said the company has designed its manufacturing network and contracts to ensure minimum disruption in the face of these sorts of threats. 'In our agreements, we have supplied safeguards and comprehensive information about how we will not only meet the timelines … but also the kind of preparedness measures that we put in place to protect supply chains,' he said. 'It's something that we take very seriously.' CSL Seqirus Liverpool's refrigerated warehouse, where vaccines for flu – including H5N1 – are stored before shipment - Simon Townsley/The Telegraph The company – which has manufacturing sites in the UK, US and Australia – is one of the world's largest producers of seasonal flu shots. It also has a bird flu vaccine programme, plus a separate initiative to create pandemic-specific vaccines. If the WHO declared a pandemic, all manufacturing would switch to solely respond to the given outbreak. The pharmaceutical firm's latest deal reserves 27.5m pandemic flu doses for 17 participating EU member states, which would be manufactured at the CSL Seqirus site in Liverpool using an egg-based production method. The company now has deals to supply pandemic shots to more than 30 governments worldwide, including the UK. Mr Longstaff said he could not discuss specifics of the contracts – which include reservation fees that are invested in 'maintaining readiness and preparedness' – and downplayed the ramifications of potential tensions between governments in a pandemic scenario. He also stressed that the company would support lower income countries through the WHO's Pandemic Influenza Preparedness (PIP) framework. Agreed after the 2009 swine flu outbreak, this requires companies to donate 10 per cent of their pandemic influenza shots, in real time. This principle has also been incorporated into the new WHO pandemic treaty, set to be approved at the World Health Assembly in Geneva later this month, in an attempt to ensure that wealthy countries are not the only ones who have access to medical countermeasures in the event of an outbreak. Protect yourself and your family by learning more about Global Health Security Broaden your horizons with award-winning British journalism. 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Yahoo
20-04-2025
- Health
- Yahoo
Chilling figure amid horror flu season
Peak flu season is about to hit Australia and cases are already 30 per cent higher compared to the same time last year. A record number of cases have been reported to the National Notifiable Diseases Surveillance System, and the rates were higher than what authorities saw during Covid. CSL Seqirus medical director Jules Bayliss said more than 58,000 cases of influenza had been recorded this year across all age groups, but the greatest number were in children. She said despite vaccinations being free for children aged under five through the National Immunisation Program, vaccination rates in recent years had been lower than what they would like in children. 'We're seeing rates of flu notifications that are higher than what we saw for Covid across nearly every age group,' Dr Bayliss said. 'Typically, children come into contact and are more likely to transmit than other age groups. 'Things we do as adults to reduce the risk of flu, like getting a vaccination, washing hands, staying home when you're unwell, can be more challenging with children.' Dr Bayliss said people often underestimated how serious the flu could be, which was different to a cold. 'It's a disease that can leave you in bed for a number of days feeling really unwell with fever, muscle aches, and a more severe full body infection than a simple cold,' she said. 'Most people have a number of days off then they return to work or school. 'Other people can end up with really serious disease that leaves them ending up in hospital. 'But we are also seeing that people are not getting vaccinated against influenza.' Dr Bayliss said while the flu vaccine was more available and accessible than ever before, it had been challenging to re-engage with people to get vaccinated following the pandemic. She said CSL had manufactured and released more than seven million vaccine doses to pharmacies and GPs across the nation ahead of flu season. They use a process led by the World Health Organisation to annually update the strains that are in the vaccines, which gives them the best chance of protection against strains that are circulating. 'Typically, the peak of the flu season occurs in late winter or early spring, but every year is a little bit different,' she said. 'It's different depending on the viruses themselves that are circulating, how readily they transmit between individuals, which populations they're circulating in, and which of the individual viruses is dominating in any particular year. 'It becomes really difficult to predict what next year's flu season will look like based on this years.' She said with the Easter holiday period and an increase in flu circulating, it was expected more cases would occur and now was the time to get vaccinated. 'There are cohorts that are covered under the National Immunisation Program that applies across the country to under fives,, over 65s and people that have an underlying medical condition,' she said. 'Free vaccines are only provided in some states, but for everybody else, they can access flu vaccines through their GP or pharmacy.' Australian chief medical officer Anthony Lawler said influenza was the most common vaccine-preventable disease in Australia. The professor said while they could not predict this year's flu season, they could learn from data collected last year which showed children aged under nine had the highest notification rates, but had a low vaccine uptake. 'In 2024, there were more deaths involving influenza and RSV than in 2023,' he said. 'This is an important reminder that influenza, RSV and Covid are not the common cold. 'These are very serious viruses that can cause severe illness, hospitalisation and even death among otherwise healthy children and adults.' Professor Lawler said so far in 2025, there had been a higher proportion of influenza B cases than seen at this time in recent years, particularly in school-aged children and young adults. 'Influenza B is often more common in children, and can result in more severe infections in children,' he said. 'The good news is that all the influenza vaccines available in Australia cover both influenza A and B, making the seasonal influenza vaccine very effective at protecting people from needing to go to hospital or visit their GP due to complications from influenza.' He recommended everyone from the age of six months get vaccinated against influenza every year, and encouraged pregnant women to get vaccinated against RSV and whooping cough and people over 65 years to get regular Covid vaccinations.
Telegraph
20-03-2025
- Health
- Telegraph
A world of pain: How a ‘safe' painkiller unleashed a new wave of opioid addiction
After years of misery, Brad Lievoort managed to beat his addiction to oxycodone. In 2018, he and his wife, Linda Matthews, from Victoria, Australia, were hosting game nights and taking weekend trips. They had made it, Linda thought. Brad felt happy to be alive. But when Brad developed chronic headaches, a doctor prescribed a drug they weren't familiar with: tapentadol. Another opioid. Brad trusted his doctor – but within two years he would be dead. In the last five years, prescriptions of this lesser-known opioid have surged as Grünenthal, the family-owned German company that developed tapentadol, has marketed the drug as a safer alternative to traditional opioids. Now it is accused of having downplayed addiction risks to doctors and influencing regulation governing its prescription, in an investigation by The Examination, a specialist team of global health reporters. Booming sales Grünenthal gained notoriety in the late 1950s with thalidomide, branded as Contergan, a drug used for morning sickness that caused thousands of miscarriages, stillbirths, and severe birth defects. The company developed tapentadol, branded as Palexia or Nucynta, as patents expired on tramadol, its first blockbuster opioid, which is now widely abused globally. Approved in 2008 in the US and 2010 in Europe and Australia, Grünenthal sells tapentadol in Europe and Latin America and collects royalties from licensees elsewhere. Sales and prescriptions have risen around the globe in recent years in at least 10 countries, according to data collected by The Examination. In Spain, tapentadol prescriptions have now surpassed oxycodone. In Australia, tapentadol has become the most prescribed opioid, with CSL Seqirus, the licenced seller, boasting last year that it was the 'only opioid with consistent growth.' Addiction danger But experts are worried the opioids' addictive properties have been played down, causing the drug to be prescribed for long term for chronic pain, against the guidance of UK and US regulators. Grünenthal and other opioid sellers have funded studies and articles in medical journals suggesting tapentadol is less likely to cause dependence or abuse. Yet six independent experts who reviewed this research unanimously found no convincing evidence to support such claims. 'I have tried to find evidence – solid, impartial evidence – of tapentadol's less addictive properties, and I have not been able to find this,' said Eveline van Dorp, an anaesthesiologist and epidemiologist with a specific interest in opioid research at Leiden University Medical Center in the Netherlands. In a medical journal, The Examination found that Grünenthal employees touted the drug's supposed 'low level of abuse,' a misleading claim repeated in a video posted on the company's website for Latin American doctors. The video also minimised the drug's risk of respiratory depression – slower breathing – a known opioid side effect. Grünenthal took down the website following enquiries from The Examination. Seven former Grünenthal employees who worked in the marketing, science and sales divisions also said in interviews for this story that tapentadol causes less dependence than other opioids. In Germany, Grünenthal promoted tapentadol to doctors as 'highly effective' for chronic pain, contradicting guidance from the World Health Organization, and from regulators in the United States and the United Kingdom. Influence Grünenthal wields wide-ranging influence through funding doctors, medical organisations, patient groups and educational initiatives across Latin America and Europe. In the last decade, Grünenthal has paid more than $9 million to help support at least 900 European patient groups and medical organisations, according to data analysed by The Examination. One company-funded association lobbied the Mexican Congress to loosen regulations around prescribing tapentadol. Rob Poole, a psychiatrist who ran a clinic in Wales to help patients come off opioids, said many pain doctors are enthusiastic about tapentadol, prescribing it as a 'wonder drug'. He described Grünenthal's promotion of tapentadol as 'a classic drug company disinformation campaign.' In a statement, Grünenthal acknowledged that 'a few' company documents had mischaracterised tapentadol's addiction risks. The company commissioned an independent audit in 2019 and found that claims that tapentadol was less addictive than other opioids were 'not backed up by sufficient scientific references.' But Grünenthal denied actively promoting the drug as less addictive and said addiction risks are included in every pack of pills and in product information for doctors. And, it said, tapentadol is approved for moderate to severe chronic pain in some countries and the labels vary depending on the regulations. The World Health Organization, the US Food and Drug Administration and independent doctors have warned that tapentadol, like any other opioid, causes dependence and has potential for addiction, misuse and abuse. Escalating harms Lucas Trautman, medical director at Oxford Treatment Center in Mississippi, said his facility has gone from rarely seeing tapentadol-dependent patients to treating them regularly over the past three years. In Australia, a report by the Coroners Court of Victoria noted an increase from zero 0 to 118 overdose deaths over a seven year stretch ending in 2023. 'The rise in tapentadol-involved overdose deaths is reminiscent of what happened when other analgesic products (such as extended release oxycodone …) were introduced,' the report states. CSL Seqirus said in a statement that the report's findings show that there is an 'ongoing need to ensure all healthcare professionals are aware that tapentadol has potential for harm.' In India, where generic companies sell tapentadol instead of Grünenthal's branded product, there is anecdotal evidence of a sharp rise in teenage boys becoming addicted since 2017, according to psychiatrists at a major addiction centre. Patients from impoverished areas buy the tablets to crush, mix with water and inject. One 21-year-old who became addicted in high school said withdrawal left him weak, tired and without the energy to brush his teeth, wash his face or speak. 'I would always be sad,' he said. Industry-funded studies Since tapentadol's introduction, Grünenthal, its licensees or researchers receiving industry funding have published studies or articles suggesting it causes less dependence, addiction or abuse. The Examination sent five such studies to medical experts who identified a variety of shortcomings. 'The studies do NOT permit the conclusion that tapentadol leads to less dependence with any certainty,' said Kyla Thomas, professor of public health medicine at Bristol Medical School. Health authorities have also raised concerns. When approving tapentadol, the FDA concluded it had 'high abuse potential.' The World Health Organization warned about its risks in 2014. French and Canadian health authorities also recommended against reimbursing slow-release tapentadol due to high costs, lack of evidence for chronic pain benefit, and abuse concerns. Insiders speak out At least seven former Grünenthal employees in Germany and the UK said in interviews with The Examination that they promoted tapentadol as less likely to cause dependence. One former sales representative, who left in 2023 after six years and did not want to be named out of fear for her career, said she was trained to promote the drug this way using company-provided materials and seminars. Lack of dependence played a 'major role' in her marketing, she said. Jan-Uwe Claas, a former senior vice president for marketing in Europe, who worked for Grünenthal for two decades until 2022, downplayed the possibility of addiction, A video on Grünenthal's educational site for healthcare professionals across Latin America featured Silvia Allende-Pérez, head of a public pain clinic in Mexico and former Grünenthal employee, promoting tapentadol. It included a Grünenthal-branded slide claiming tapentadol has a 'minimum potential of abuse' and that respiratory depression is 'not reported' despite this being a well-known opioid side effect. Grünenthal said the video did not reflect current evidence and, after The Examination's inquiry, removed it and took the website offline for review. Allende-Pérez did not respond to requests for comment. Grünenthal has also funded the Mexican Association for the Study and Treatment of Pain, according to Angel Juárez, president of the organisation until last year. Grünenthal said in response that it operates with the 'highest ethical standards' when partnering with healthcare professionals and organisations. Welsh prescriptions In Wales, the Abertawe Bro Morgannwg University Health Board raised warnings about Grünenthal's marketing of tapentadol in 2019 after discovering the area had more prescriptions than anywhere else in the country. 'Tapentadol is extremely similar to tramadol which was also launched (by the same pharmaceutical company) with similar claims of safety, tolerability and lack of 'addiction' potential, all of which have subsequently been proven false,' the health board said in an internal report. Caroline Hildenbfrand-Nixdorf, a family doctor in northern Bavaria said Grünenthal sales representatives told her tapentadol was 'not an opioid' but a 'hybrid between an opioid and normal pain medication' that leads to 'no or little dependence' and encouraged its use for chronic pain. 'There is a feeling among doctors, nursing staff, but also patients … that these are harmless substances,' said Dominikus Bönsch, addiction specialist and medical director at the District Hospital Lohr am Main in Bavaria. 'It's pure nonsense,' he said. 'A myth.' A needless death In Australia, Linda Matthews had given birth to triplets. But her husband Brad's tapentadol prescription triggered a relapse. His addiction raged. He couldn't keep a job and hardly helped with the children. When he skipped the triplets' first Christmas, Linda, seeing no hope, asked him to move out. Five months later, police found Brad dead, clutching pills in his hand. A coroner's report found he had overdosed on tapentadol and oxycodone, both drugs found in life-threatening amounts. In the six months before his death, he had been prescribed opioids by more than 10 doctors. 'Brad made some really, really bad decisions,' said Linda. 'But he shouldn't ever have been able to get the amount of stuff that he was getting.' World of Pain is an investigative collaboration involving reporting by The Examination, Paper Trail Media, Latin American Center for Investigative Journalism (CLIP), PlatôBR, Salud Con Lupa, El Espectador and Der Spiegel.
