Latest news with #CSLSeqirus
Reuters
25-06-2025
- Health
- Reuters
Vaccines and antibodies up for debate at CDC advisory panel meeting
June 25 (Reuters) - The Centers for Disease Control and Prevention's vaccine advisory committee is set to meet for the first time since Health Secretary Robert F. Kennedy Jr. fired the entire panel and named eight new members, half of whom have advocated against vaccines. The meeting, scheduled for June 25-26, will review existing data and vote on RSV and influenza vaccines, along with thimerosal, a preservative used in vials of medicines and vaccines. Below are some of the companies that make the vaccines that will be discussed at the meeting, according to the final agenda published on the CDC's website. Sanofi ( opens new tab Fluzone - The quadrivalent influenza vaccine was approved in 2013 for patients aged six months and older. Flublok - Approved in 2016 for adults aged 18 and older, replacing the trivalent version licensed in 2013 by offering protection against four influenza strains. Sanofi reported U.S. sales of $1.66 billion for influenza vaccines in 2024. AstraZeneca/MedImmune [RIC:RIC: FluMist - FDA approved AstraZeneca and partner MedImmune's nasal spray influenza vaccine in September 2024 for self-administration by adults up to 49 years of age, or by a parent/caregiver to individuals aged 2-17 years. The vaccine generated sales of about $258 million in 2024. CSL Seqirus, part of Australia-based biotech firm CSL Ltd ( opens new tab FlucelVax - The FDA approved the cell-based influenza vaccine in October 2021 for people aged six months and older. Afluria - The egg-based influenza vaccine was approved in October 2018 for people aged six months and older. Fluad - The adjuvanted influenza vaccine was approved by the FDA in February 2020 for people aged six months and older. The three vaccines combined brought in sales of $1.72 billion in 2024 RSV VACCINES Sanofi/AstraZeneca (AZN.L), opens new tab Nirsevimab (Beyfortus) - The FDA approved the antibody, branded as Beyfortus, in 2023 to prevent respiratory syncytial virus (RSV) infections in infants. Sanofi reported U.S. sales of $1.24 billion for the vaccine in 2024. Merck ((MRK.N), opens new tab) Clesrovimab (Enflonsia) - The company gained approval for its RSV-preventing antibody, branded as Enflonsia, in June 2025. The antibody is designed for infants up to one-year olds during their first RSV season, with shipments planned for the 2025-2026 season. GSK (GSK.L), opens new tab Priorix - Approved by the FDA for the prevention of measles, mumps, and rubella (MMR) in individuals aged one year and older. It can be administered in two doses or as a second shot following a prior MMR vaccination. GSK reported global sales of $439.96 million for the vaccine in 2024. MODERNA (MRNA.O), opens new tab mNEXSPIKE - The next-generation COVID-19 vaccine was approved for aged 65 and above in May 2025. Spikevax, Moderna's first COVID-19 vaccine, received its initial FDA approval in January 2022. Spikevax brought in total sales of $1.8 billion in 2024. Pfizer (PFE.N), opens new tab/BioNTech ( opens new tab Comirnaty - The COVID-19 vaccine was approved by the FDA in August 2021 for people aged 16 years and older. It generated sales of $5.35 billion in 2024. Novavax (NVAX.O), opens new tab Nuvaxovid - The protein-based COVID-19 vaccine was approved by FDA in May 2025 for people aged 65 and older, following nearly five years of regulatory delays and financial uncertainty. The vaccine, Novavax's sole commercial product, generated $682 million in total revenue for 2024, which includes licensing and royalties.
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.
