Latest news with #TonyWood
Daily Mail
14-05-2025
- Health
- Daily Mail
GSK agrees $2bn deal to buy potential liver disease treatment
GSK has struck an agreement worth up to $2billion to buy a medicine that could treat fatty liver disease. The drugs giant plans to pay $1.2billion upfront to acquire Efirmosfermin from Boston Pharmaceuticals, followed by potential success-based milestone payments of $800million. It said the takeover was 'highly aligned' with its research and development focus on 'science related to the immune system'. Efirmosfermin is being developed as a treatment for steatotic liver disease (SLD), a condition whereby excessive fat accumulates in a person's liver. Common risk factors of SLD include being overweight or obese, hepatitis C, high blood pressure, Type 2 diabetes and drinking too much alcohol. Around 30 per cent of adults worldwide are affected by the condition, according to a US National Institutes of Health study. The leading causes of liver transplants in the US are both different types of SLD: Alcoholic liver disease (ALD) and Metabolic dysfunction-associated steatohepatitis (MASH). GSK noted results from a recent Phase II trial showed that Efirmosfermin 'rapidly and significantly' reversed liver fibrosis and halted its progression in patients with MASH. Tony Wood, chief scientific officer at GSK, said: 'Efirmosfermin has the potential to define a new standard-of-care with its monthly dosing and tolerability profile. 'Efimosfermin will significantly expand our hepatology pipeline and provide us the opportunity to develop a new potential best-in-class medicine with first launch expected in 2029.' A study published in the Journal of Hepatology in January estimated that reducing moderate-to-advanced fibrosis to stop cirrhosis and liver cancer progressing could save the US healthcare system between $40billion and $100billion over the coming two decades. Elias Zerhouni MD, chair of Boston Pharmaceuticals' board of directors, said: 'We are delighted that GSK, a global leader, recognised Efimosfermin's potential to address a growing global public health concern and unmet medical need. 'Together, we look forward to Efimosfermin's ongoing journey to become a best-in-class treatment for patients with SLD.' GSK's announcement comes after the firm claimed it was 'well positioned' to deal with US tariffs. The FTSE 100 business derives around half of its turnover from the US, so import taxes on drugs entering the country could severely impact its bottom line. GSK shares were 0.5 per cent higher at 1,364.5p on Wednesday morning, but have still shrunk by around 24 per cent in the past year.
Yahoo
30-04-2025
- Politics
- Yahoo
Nuclear is back on Australia's election agenda - will it reignite toxic 'climate wars'?
In the Hunter Valley, long, brown trains chug through lush pastures, carrying stacks of black rock - the lifeblood of the region, though not for much longer. This has long been Australia's coal country. But the area, a three-hour drive from Sydney, is now begrudgingly on the frontline of the country's transition to clean energy. "This town was built around a coal mine," says Hugh Collins from Muswellbrook, "so it'll be a big shift. I don't know what will happen." Nowhere captures this dilemma quite like the soon-to-be demolished smokestacks of Liddell power station, which tower over the rolling hillside nearby. Liddell, one of Australia's oldest coal plants, was closed two years ago. Across the highway is sister-power station Bayswater, scheduled for retirement by 2033. Liddell's owners want to redevelop both stations into a renewable energy hub – in line with the Labor government's plans for a grid powered almost completely by solar and wind energy. The opposition Liberal-National coalition, though, has proposed converting Liddell into one of seven nuclear power plants across the country. Currently banned, nuclear is the controversial centrepiece of the Coalition's clean energy plan. Nuclear has historically been deeply unpopular among Australians scared of having radioactive plants in their metaphorical backyards. But with the Coalition plugging it as a cheap and reliable option to complement renewables, interest is growing. Ahead of the election on 3 May, each party has insisted that their visions are the best way to both fulfil Australia's commitment to net zero emissions by 2050 and tame rising power bills. But there are fears this renewed debate over Australia's energy future takes the country back to the past. Brutal arguments over climate change had plagued Australian politics for years – but the incoming Labor government last election declared that era was over. Now experts worry the so-called "climate wars" are back, and this could potentially delay the urgent emissions reduction the globe has been begging the country to take for years. "I don't think peace will be declared no matter what happens with the election," says Tony Wood from the Grattan Institute think tank. It is hard to overstate just how central coal has been to the Hunter region. In 1799, Newcastle, the area's biggest city, farewelled Australia's first commodity export – a shipment of coal. Today it is home to the world's largest coal port, with A$38.6bn-worth ($26.8bn; £18.9bn) passing through in 2023. The livelihoods of about 52,000 people here rely on coal mines, power stations or supporting industries. Made up of a handful of parliamentary seats, the region has traditionally been a Labor stronghold. But in recent years electorates like Hunter and Paterson have been faltering, and the Coalition is banking on its vision of a nuclear-powered future to win over these largely blue-collar constituents. It says it can have the first nuclear plant up and running by 2037 and that nuclear plants will provide a similar number and range of jobs as the coal-fired power stations they're going to supersede. "I think in the Hunter, and elsewhere to be honest, people realise that if there is not a replacement industry for coal, then these jobs go," opposition leader Peter Dutton said on the campaign trail. While nuclear power has been part of the energy mix in many countries around the globe for decades, this is uncharted territory for Australia. The country's only nuclear reactor, at Lucas Heights in Sydney, is used for medical research. Nuclear has been banned at a federal level since the late 1990s. If the Coalition wins the election, it could convince parliament to overturn that, but persuading states to scrap their own bans on nuclear may not be so simple. Leaders in four of the five states where nuclear plants are proposed have outright ruled out doing so. Critics also say the Coalition's claims on timeframe and its $300bn price tag are unrealistic given the need to train workers, develop regulations and build the infrastructure. Some have accused it of simply trying to prolong the use of fossil fuels - the ageing coal plants will have to run for longer to plug the energy gap. From Mr Collins' perspective, that wouldn't be so bad. "Being in the coal industry, I would like coal to go as long as possible," he says. But he understands the need to "embrace" cleaner sources of energy. Though a variety of sources "all have their place", he is particularly interested in nuclear. "There [may have been] a lot of scary notions around nuclear power... but technology has come a long way," he says, referring to deadly disasters like Chernobyl in 1986 and Fukushima in 2011. But others in Muswellbrook are adamant the need for employment in the region does not outweigh the "risks" of nuclear. "Liddell's closure meant a few jobs were lost but I don't think that really affected the community... I think [nuclear] is dangerous," says 25-year-old Chloe. Another cafe owner simply says "it's not going to happen". "We don't have the technology to build it. We can't afford it," he says. "We're always going to have to burn coal, I believe." The topic clearly evokes strong feelings. Many people here are more than happy to share their opinions with the BBC, but are hesitant to be named or photographed. "Our community group is ruthless," one woman explains. But elsewhere in the Hunter region, it is Labor's renewables plan that is stirring heated conversation. Renewables currently supply 46% of Australia's electricity and Labor wants to raise the proportion to 82% by 2030. As weather is unpredictable, this plan must be backed up by batteries and gas, it argues. "Australia needs to be ambitious. We must be optimistic… We can be a renewable energy superpower for the world," Prime Minister Anthony Albanese said last month, adding that this vision will create jobs in "every part of the country". Ben Abbott is one of those unconvinced by these plans. "We are not experts in energy. But where we will put our hat into the ring is when it concerns where we live. We know what's at stake," said Mr Abbott, who is president of No Offshore Turbines Port Stephens. The government has earmarked a 1,854 sq m (20,000 sq ft) area between Newcastle and Port Stephens - a popular spot for whale watching and game fishing - as Australia's second offshore wind zone. Mr Abbott's group is concerned that the construction and operation of wind turbines will disturb marine life – though scientists say more research is needed – and adversely affect tourism. He also accused Labor of running a "scare campaign" against nuclear. Some in the party have savaged the opposition's nuclear pitch by flooding social media with, among other things, memes featuring beloved cartoon koala Blinky Bill with three eyes. "I'd like to learn more about it from an impartial point of view, not as a political issue," Mr Abbott says. On the other hand, some have also accused the Coalition of capitalising on fear around wind farms. Billboards along the highway to Port Stephens profess that only their local candidate will "stop Labor's offshore wind farms". There is also concern that local anti-renewables movements are being driven or backed by people who outright reject climate change, as a tactic to delay the country's turn away from fossil fuels. According to Guardian Australia, that includes the Saltbush Club, a group of the country's most prominent and powerful climate change deniers. Mr Abbott says the Port Stephens campaign is not one of these. "None of us are against renewables," he says, noting that he agrees with the commitment to net zero. The conversations taking place in the Hunter region are playing out on a national level too. Polls indicate the country is still split on the best path forward, with support for nuclear hovering around 40%, with the rest fluctuating between undecided or opposed. For every argument from each side of the debate, there's a point to counter it on the other. Both parties have been flouting the jobs created for communities hosting their energy infrastructure, but have been using cost-of-living relief to appeal to the nation more broadly. However the price tag on each of these plans depends on who you ask. Labor has for years said a grid dominated by renewables would cost A$122bn, and has dangled energy bill rebates and discounts on solar home batteries as part of its pitch. But the Coalition says they believe it will cost at least five times more, and that their plan is half the price. They too have promised lower power bills with nuclear. Australia's national science agency, though, says they estimate electricity generated from nuclear reactors will cost twice as much as renewable energy, even after accounting for their longer lifespans. Environmental economics professor Frank Jotzo argues that the Coalition's promises can only be put to test a long time in the future. "Given that Australia runs on three-year terms of government, they will not be under pressure to deliver," he says. Grattan Institute's Mr Wood believes the Coalition is wielding nuclear energy as a political weapon, noting that Australia has for at least the last decade seen bipartisan support for renewables. "They needed a point of difference. And nuclear met the objective," he says. Both note the Coalition has already signalled it could abandon Australia's 2030 emissions reduction target if it wins government – while Labor says it is on track to meet it. "A Coalition government, majority or minority, would have very big challenges introducing the nuclear proposal. I suspect we would see an escalation in the climate war," Mr Wood said. But nuclear advocates are frustrated nuclear power isn't even an option here. While Australia has abundant solar and wind resources, these are intermittent, says nuclear engineer Jasmin Diab. Nuclear is more reliable and facilities last twice as long - so she argues an "ideal energy mix" would be heavy on renewables with a "backbone built on nuclear". "Labor's position prevents Australia from making use of what's going to be an important source of energy in the future," said nuclear law expert Helen Cook. She points to countries across the world already benefiting from nuclear energy, such as the US and Canada, and several others at least studying it, including Indonesia. But Justin Page, from the Hunter Jobs Alliance, argues the Hunter doesn't have time to opt for the Coalition's "fundamentally flawed" plan. The region is well on the way in its transition to renewables, he says, with proposed wind projects, for example, expected to create some 3,000 jobs. "To go nuclear will mean starting off the ground… Such a transition will take too long and be too costly," he says. "It will be ridiculous to change courses now." Many Hunter residents say they just want certainty. "The best plan will be for the two parties to get together and come up with a credible, realistic and deliverable plan... rather than using such a serious issue for electioneering," one Newcastle resident tells us. Australia's universal healthcare is crumbling. Can it be saved? Peter Dutton: The ex-cop who brought Australia's opposition back from the brink Anthony Albanese: The 'working-class hero' who fell out of favour
BBC News
30-04-2025
- Politics
- BBC News
Nuclear is back on Australia's election agenda. Will it reignite toxic 'climate wars'?
In the Hunter Valley, long, brown trains chug through lush pastures, carrying stacks of black rock - the lifeblood of the region, though not for much has long been Australia's coal country. But the area, a three-hour drive from Sydney, is now begrudgingly on the frontline of the country's transition to clean energy."This town was built around a coal mine," says Hugh Collins from Muswellbrook, "so it'll be a big shift. I don't know what will happen."Nowhere captures this dilemma quite like the soon-to-be demolished smokestacks of Liddell power station, which tower over the rolling hillside nearby. Liddell, one of Australia's oldest coal plants, was closed two years ago. Across the highway is sister-power station Bayswater, scheduled for retirement by owners want to redevelop both stations into a renewable energy hub – in line with the Labor government's plans for a grid powered almost completely by solar and wind opposition Liberal-National coalition, though, has proposed converting Liddell into one of seven nuclear power plants across the country. Currently banned, nuclear is the controversial centrepiece of the Coalition's clean energy plan. Nuclear has historically been deeply unpopular among Australians scared of having radioactive plants in their metaphorical backyards. But with the Coalition plugging it as a cheap and reliable option to complement renewables, interest is of the election on 3 May, each party has insisted that their visions are the best way to both fulfil Australia's commitment to net zero emissions by 2050 and tame rising power bills. But there are fears this renewed debate over Australia's energy future takes the country back to the arguments over climate change had plagued Australian politics for years – but the incoming Labor government last election declared that era was experts worry the so-called "climate wars" are back, and this could potentially delay the urgent emissions reduction the globe has been begging the country to take for years."I don't think peace will be declared no matter what happens with the election," says Tony Wood from the Grattan Institute think tank. Small town, big debate It is hard to overstate just how central coal has been to the Hunter 1799, Newcastle, the area's biggest city, farewelled Australia's first commodity export – a shipment of coal. Today it is home to the world's largest coal port, with A$38.6bn-worth ($26.8bn; £18.9bn) passing through in livelihoods of about 52,000 people here rely on coal mines, power stations or supporting up of a handful of parliamentary seats, the region has traditionally been a Labor stronghold. But in recent years electorates like Hunter and Paterson have been faltering, and the Coalition is banking on its vision of a nuclear-powered future to win over these largely blue-collar says it can have the first nuclear plant up and running by 2037 and that nuclear plants will provide a similar number and range of jobs as the coal-fired power stations they're going to supersede."I think in the Hunter, and elsewhere to be honest, people realise that if there is not a replacement industry for coal, then these jobs go," opposition leader Peter Dutton said on the campaign trail. While nuclear power has been part of the energy mix in many countries around the globe for decades, this is uncharted territory for country's only nuclear reactor, at Lucas Heights in Sydney, is used for medical research. Nuclear has been banned at a federal level since the late 1990s. If the Coalition wins the election, it could convince parliament to overturn that, but persuading states to scrap their own bans on nuclear may not be so simple. Leaders in four of the five states where nuclear plants are proposed have outright ruled out doing also say the Coalition's claims on timeframe and its $300bn price tag are unrealistic given the need to train workers, develop regulations and build the infrastructure. Some have accused it of simply trying to prolong the use of fossil fuels - the ageing coal plants will have to run for longer to plug the energy Mr Collins' perspective, that wouldn't be so bad. "Being in the coal industry, I would like coal to go as long as possible," he says. But he understands the need to "embrace" cleaner sources of energy. Though a variety of sources "all have their place", he is particularly interested in nuclear."There [may have been] a lot of scary notions around nuclear power... but technology has come a long way," he says, referring to deadly disasters like Chernobyl in 1986 and Fukushima in others in Muswellbrook are adamant the need for employment in the region does not outweigh the "risks" of nuclear."Liddell's closure meant a few jobs were lost but I don't think that really affected the community... I think [nuclear] is dangerous," says 25-year-old cafe owner simply says "it's not going to happen"."We don't have the technology to build it. We can't afford it," he says. "We're always going to have to burn coal, I believe."The topic clearly evokes strong feelings. Many people here are more than happy to share their opinions with the BBC, but are hesitant to be named or photographed. "Our community group is ruthless," one woman explains. But elsewhere in the Hunter region, it is Labor's renewables plan that is stirring heated currently supply 46% of Australia's electricity and Labor wants to raise the proportion to 82% by 2030. As weather is unpredictable, this plan must be backed up by batteries and gas, it argues."Australia needs to be ambitious. We must be optimistic… We can be a renewable energy superpower for the world," Prime Minister Anthony Albanese said last month, adding that this vision will create jobs in "every part of the country".Ben Abbott is one of those unconvinced by these plans. "We are not experts in energy. But where we will put our hat into the ring is when it concerns where we live. We know what's at stake," said Mr Abbott, who is president of No Offshore Turbines Port government has earmarked a 1,854 sq m (20,000 sq ft) area between Newcastle and Port Stephens - a popular spot for whale watching and game fishing - as Australia's second offshore wind Abbott's group is concerned that the construction and operation of wind turbines will disturb marine life – though scientists say more research is needed – and adversely affect also accused Labor of running a "scare campaign" against nuclear. Some in the party have savaged the opposition's nuclear pitch by flooding social media with, among other things, memes featuring beloved cartoon koala Blinky Bill with three eyes."I'd like to learn more about it from an impartial point of view, not as a political issue," Mr Abbott says. On the other hand, some have also accused the Coalition of capitalising on fear around wind farms. Billboards along the highway to Port Stephens profess that only their local candidate will "stop Labor's offshore wind farms".There is also concern that local anti-renewables movements are being driven or backed by people who outright reject climate change, as a tactic to delay the country's turn away from fossil fuels. According to Guardian Australia, that includes the Saltbush Club, a group of the country's most prominent and powerful climate change Abbott says the Port Stephens campaign is not one of these. "None of us are against renewables," he says, noting that he agrees with the commitment to net zero. The conversations taking place in the Hunter region are playing out on a national level indicate the country is still split on the best path forward, with support for nuclear hovering around 40%, with the rest fluctuating between undecided or every argument from each side of the debate, there's a point to counter it on the parties have been flouting the jobs created for communities hosting their energy infrastructure, but have been using cost-of-living relief to appeal to the nation more the price tag on each of these plans depends on who you has for years said a grid dominated by renewables would cost A$122bn, and has dangled energy bill rebates and discounts on solar home batteries as part of its pitch. But the Coalition says they believe it will cost at least five times more, and that their plan is half the price. They too have promised lower power bills with national science agency, though, says they estimate electricity generated from nuclear reactors will cost twice as much as renewable energy, even after accounting for their longer lifespans. Environmental economics professor Frank Jotzo argues that the Coalition's promises can only be put to test a long time in the future. "Given that Australia runs on three-year terms of government, they will not be under pressure to deliver," he Institute's Mr Wood believes the Coalition is wielding nuclear energy as a political weapon, noting that Australia has for at least the last decade seen bipartisan support for renewables."They needed a point of difference. And nuclear met the objective," he note the Coalition has already signalled it could abandon Australia's 2030 emissions reduction target if it wins government – while Labor says it is on track to meet it."A Coalition government, majority or minority, would have very big challenges introducing the nuclear proposal. I suspect we would see an escalation in the climate war," Mr Wood nuclear advocates are frustrated nuclear power isn't even an option Australia has abundant solar and wind resources, these are intermittent, says nuclear engineer Jasmin Diab. Nuclear is more reliable and facilities last twice as long - so she argues an "ideal energy mix" would be heavy on renewables with a "backbone built on nuclear"."Labor's position prevents Australia from making use of what's going to be an important source of energy in the future," said nuclear law expert Helen Cook. She points to countries across the world already benefiting from nuclear energy, such as the US and Canada, and several others at least studying it, including Indonesia. But Justin Page, from the Hunter Jobs Alliance, argues the Hunter doesn't have time to opt for the Coalition's "fundamentally flawed" region is well on the way in its transition to renewables, he says, with proposed wind projects, for example, expected to create some 3,000 jobs."To go nuclear will mean starting off the ground… Such a transition will take too long and be too costly," he says. "It will be ridiculous to change courses now."Many Hunter residents say they just want certainty."The best plan will be for the two parties to get together and come up with a credible, realistic and deliverable plan... rather than using such a serious issue for electioneering," one Newcastle resident tells us.
Yahoo
17-04-2025
- Health
- Yahoo
AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices
Over 13 million adults aged 50-59 at increased risk in the US can potentially benefit from RSV immunization1 RSV causes an estimated 42,000 hospitalizations* each year in adults aged 50-64 years old in the US2 PHILADELPHIA, April 16, 2025--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) is pleased that the Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of RSV vaccines including GSK's AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50-59 who are at increased risk for severe RSV disease. This includes people with conditions like COPD, asthma, diabetes, heart disease and those in residential care3. This expands on ACIP's previous vote in June 2024 to recommend RSV vaccines for adults aged 60-74 who are at increased risk and all adults aged 75 and older. AREXVY is indicated for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older, as well as individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. A systematic review of studies in the US shows that RSV is estimated to cause 42,000 hospitalizations* each year in adults aged 50-64 years old.2 Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk from severe consequences from an RSV infection compared to those without these conditions.4,5 RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.5 Tony Wood, Chief Scientific Officer, GSK: "We are pleased with ACIP's recommendation to expand the benefits of RSV immunization to more than 13 million adults aged 50-59 who are at increased risk for the severe consequences of this virus. RSV can have a significant impact for those with underlying medical conditions. We look forward to helping protect more people with RSV vaccination." In making its recommendation, the ACIP considered positive results from a phase III trial [NCT05590403]6 evaluating the immune response and safety of GSK's RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions compared to older adults aged 60 years and older where efficacy has been demonstrated after a single dose of GSK's RSV vaccine. The ACIP recommendations will be forwarded for review and approval. Once approved, the final recommendations will be published to advise healthcare providers on appropriate use of the vaccine and to inform insurance coverage. About AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)AREXVY contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK's proprietary AS01E adjuvant. The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 61 countries, including Europe, Japan and US. In addition, it is approved in the US, EU/EEA countries and Japan for use in individuals aged 50-59 who are at increased risk for lower respiratory disease caused by RSV due to certain underlying medical conditions. Regulatory reviews for this extended indication are ongoing in other countries. The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees. The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus. Indication for AREXVYAREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: Individuals 60 years of age and older; Individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. Important Safety Information for AREXVY AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY In adults 60 years of age and older, the most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%) In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%) There are no data on the use of AREXVY in pregnant or breastfeeding individuals. AREXVY is not approved for use in persons <50 years of age Vaccination with AREXVY may not result in protection of all vaccine recipients Please see full Prescribing Information for AREXVY. About RSV in adultsRSV is a common contagious virus affecting the lungs and breathing passages. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age.5 RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.5 Each year, RSV is estimated to cause approximately 177,000 hospitalizations in adults 65 years and older7 and 42,000* in adults aged 50-64 years old in the US.2 About GSKGSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statementsGSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024. Registered in England & Wales:No. 3888792 Registered Office:79 New Oxford StreetLondonWC1A 1DG References __________________________________ * adjusted for under-detection 1 Horn et al, "Disparities in Risk Factors for Severe Respiratory Syncytial Virus Disease among Adults in the United States", Abstract presented at National Foundation for Infectious Diseases – 27 Annual Conference on Vaccinology Research – NFID 2024; May 8-10, 2024 2 McLaughlin JM et al, "Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis" in Open Forum Infectious Diseases, Volume 9, Issue 7, July 2022 3 Centers for Disease Control and Prevention (CDC), RSV vaccine guidance for older adults, August 2024. Available at: (Accessed April 2025) 4 Branche AR et al., "Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020" in Clinical Infectious Diseases, 2022:74:1004–1011 5 Centers for Disease Control and Prevention (CDC), RSV in Adults. Available at: - accessed in April 2025 6 M. Ferguson, "Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to ≥60 Years of Age" in Clinical Infectious Diseases, 2024 Oct 15;79(4):1074-1084. doi: 10.1093/cid/ciae364. 7 Falsey, AR et al. "Respiratory syncytial virus infection in elderly and high-risk adults", in New Engl J Med 2005; 352:1749-59 View source version on Contacts GSK enquiriesMedia:Tim Foley +44 (0) 20 8047 5502 (London)Simon Moore +44 (0) 20 8047 5502 (London)Kathleen Quinn +1 202 603 5003 (Washington DC)Alison Hunt +1 540 742 3391 (Washington DC) Investor Relations:Annabel Brownrigg-Gleeson +44 (0) 7901 101944 (London)James Dodwell +44 (0) 20 8047 2406 (London)Mick Readey +44 (0) 7990 339653 (London)Constantin Fest +44 (0) 7831 826525 (London)Steph Mountifield +44 (0) 7796 707505 (London)Jeff McLaughlin +1 215 751 7002 (Philadelphia)Frannie DeFranco +1 215 751 4855 (Philadelphia) Sign in to access your portfolio
Yahoo
16-04-2025
- Health
- Yahoo
GSK's 5-in-1 Meningococcal Vaccine PENMENVY Receives Positive Recommendation from US Advisory Committee on Immunization Practices
Vaccine recommended to help protect persons over 10 years old in the United States (US) against disease-causing serogroups of Neisseria meningitidis (A, B, C, W, and Y) Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect more US adolescents and young adults Vaccine doses will be ready for use in the US from Summer 2025 PHILADELPHIA, April 16, 2025--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced that the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend use of PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) as part of the adolescent meningococcal vaccination schedule. Recommendations made by the ACIP are reviewed and, if adopted, are published as official CDC recommendations. ACIP voted to recommend that persons over 10 years old receive a single dose of PENMENVY as an alternative to separate administration of meningococcal serogroups A, C, W, and Y (MenACWY) and meningococcal serogroup B (MenB) vaccinations when both vaccines would be given on the same clinic visit, typically at age 16. This recommendation, if adopted, will allow for vaccination against serogroups A, B, C, W, and Y in fewer doses, could simplify meningococcal vaccination delivery and could improve immunization rates, helping protect more US adolescents against these five disease-causing serogroups for which the US CDC has previously issued recommendations.1 GSK's MenABCWY vaccine combines the antigenic components of the Company's two well-established meningococcal vaccines—BEXSERO (Meningococcal Group B Vaccine) and MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). On February 14, 2025, the US Food and Drug Administration (FDA) approved GSK's MenABCWY vaccine for use in individuals aged 10 through 25 years.2 Tony Wood, Chief Scientific Officer at GSK, said: "We welcome this positive recommendation that can help strengthen disease prevention efforts in the US. Pentavalent vaccines can reduce the number of injections required to help protect against invasive meningococcal disease – especially disease caused by serogroup B. Their use could improve immunization rates among adolescents and young adults in the US, who are at an age with increased risk." Although MenB is the leading cause of invasive meningococcal disease (IMD) among this population, less than 13% of 17-year-olds received the recommended two-dose vaccination series; around 32% received at least one dose according to 2023 CDC survey data.3,4 Three of every four MenB doses currently administered in the US are manufactured by GSK,5 positioning the company well to lead in the US market as MenB-containing vaccination schedules must be completed with the same manufacturer's MenB vaccine.6 About IMD IMD is an uncommon but serious illness that can lead to death for up to one in ten of those who contract it in as little as 24 hours from onset, despite treatment.7 IMD is easily misdiagnosed, with early symptoms often mistaken for the flu.7,8 Approximately one in five survivors may experience long-term consequences such as brain damage, amputations, hearing loss, and nervous system problems.8 Although anyone can get IMD, adolescents and young adults between the ages of 16 and 23 years are one of the groups at highest risk due to common behaviors that help transmit the bacteria that cause IMD, such as living in close quarters like college dormitories, kissing and sharing drinks, utensils, or smoking devices.9,10 About PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) GSK's MenABCWY vaccine is an injectable suspension for intramuscular use. The vaccine is supplied as one vial of lyophilized MenACWY Component (powder) which is reconstituted at the time of use with the accompanying prefilled syringe of MenB Component (liquid). In the US, PENMENVY is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged 10 through 25 years. The FDA-approved dosing is to administer two doses six months apart. The US Prescribing Information is available here.11 Important Safety Information for PENMENVY in the US The following is based on the US Prescribing Information for PENMENVY. Please consult the full Prescribing Information for additional safety information. Do not administer PENMENVY to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of PENMENVY, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine Syncope (fainting) has occurred in association with administration of PENMENVY PENMENVY may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains Immunocompromised persons, including those receiving immunosuppressive therapy, may have reduced immune responses to PENMENVY Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis, including disease caused by serogroups A, B, C, W, and Y, even if they develop antibodies following vaccination with PENMENVY Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of a U.S.-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer PENMENVY to persons with a history of GBS should take into account the expected benefits and potential risks The most commonly reported solicited adverse reactions in individuals aged 10 through 25 years after Dose 1 and Dose 2: pain at the injection site, fatigue, headache, myalgia, nausea, erythema, and swelling. The most commonly reported solicited adverse reactions in MenACWY conjugate vaccine-experienced individuals aged 15 through 25 years after Dose 1 and Dose 2: pain at the injection site, headache, fatigue, myalgia, and nausea About BEXSERO (Meningococcal Group B Vaccine) GSK's MenB vaccine has received regulatory approval in over 55 countries, including the US, and is used in 18 national immunization programs worldwide for the prevention of IMD caused by Neisseria meningitidis serogroup B. More than 110 million doses have been distributed worldwide since 2015.12 Clinical data supported its effectiveness in helping to protect adolescents and young adults against diverse disease-causing strains of MenB, with a well-characterized safety profile. In the US, BEXSERO is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years. The US Prescribing Information is available here.13 Important Safety Information for BEXSERO in the US The following is based on the US Prescribing Information for BEXSERO. Please consult the full Prescribing Information for additional safety information. Do not administer BEXSERO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of BEXSERO or after a previous dose of BEXSERO The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions Syncope (fainting) can occur in association with administration of BEXSERO BEXSERO may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains Some individuals with altered immunocompetence may have reduced immune responses to BEXSERO Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N. meningitidis serogroup B even after being vaccinated with BEXSERO The most commonly reported solicited adverse reactions: pain at the injection site, fatigue, headache, nausea, erythema, myalgia, and swelling About MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) GSK's MenACWY vaccine has received regulatory approval in over 60 countries, including the US, with more than 80 million doses distributed worldwide since 2010.14 It offers evidence of immunogenicity with a well-characterized safety profile. In the US, MENVEO is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections. The US Prescribing Information is available here.15 Important Safety Information for MENVEO in the US The following is based on the US Prescribing Information for MENVEO. Please consult the full Prescribing Information for additional safety information. Do not administer MENVEO to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of MENVEO, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine Syncope (fainting) has occurred in association with administration of MENVEO Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MENVEO Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroups A, C, Y, and W, even after being vaccinated with MENVEO Guillain-Barré syndrome has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine Apnea following intramuscular vaccination has been observed in some infants born prematurely Common solicited adverse reactions: at 2 months of age - tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea; at 7 months through 23 months of age - tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea; at 2 through 10 years of age - injection site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Among adolescents and adults aged 11 through 55 years were pain at the injection site, headache, myalgia, malaise, and nausea - similar rates were observed following a booster dose In two clinical studies, there were no notable differences in frequency and severity of solicited adverse reactions in individuals who received MENVEO 1-vial presentation compared to individuals who received the 2-vial presentation Vaccination with MENVEO may not result in protection in all vaccine recipients About GSK GSK is a global biopharma Company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024. Registered in England & Wales:No. 3888792 Registered Office:79 New Oxford StreetLondonWC1A 1DG References: Centers for Disease Control and Prevention. About Meningococcal Vaccines. Available at: Accessed April 2025. GSK. Penmenvy, GSK's 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY. Available at: Accessed April 2025. Cheng WY, et al. Determinants of Meningococcal ACWY vaccination in adolescents in the US: completion and compliance with the CDC recommendations. Hum Vaccin Immunother. 2020;16(1):176-188. Centers for Disease Control and Prevention. National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2023. Available at: Accessed April 2025. GSK Data on File Calculation of GSK share in US MenB market January – December 2024. REF-269547. Based on information licensed from IQVIA: IQVIA, DDD, Meningococcal B market all channels, period January – December 2024, reflecting estimates of real-world activity. All rights reserved. Centers for Disease Control and Prevention. Meningococcal Vaccine Recommendations. Available at: Accessed April 2025. Thompson MJ, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397-403. Marshall GS, et al. Understanding the Sequelae of Invasive Meningococcal Disease in the United States. Infect Dis Ther. 2024;13(11):2213-2220. European Centers for Disease Control and Prevention. Outbreak of invasive meningococcal disease in the EU associated with a mass gathering event, the 23rd World Scout Jamboree, in Japan. 21 August 2015. Available at: Accessed April 2025. Centers for Disease Control and Prevention. Risk Factors for Meningococcal Disease. Available at: Accessed April 2025. GSK. US Prescribing Information for Penmenvy. Available at: Accessed April 2025. GSK Data on File. Number of Bexsero doses shipped from 2015 to November 2023 REF-219766 GSK. US Prescribing Information for Bexsero. Available at: Accessed April 2025. GSK Data on File. Menveo Doses Shipped from 2010 to end of 2022 REF-195452. GSK. Prescribing Information for Menveo. Available at: Accessed April 2025. View source version on Contacts GSK enquiries Media:Tim Foley +44 (0) 20 8047 5502 (London)Simon Moore +44 (0) 20 8047 5502 (London)Kathleen Quinn +1 202 603 5003 (Washington DC)Alison Hunt +1 540 742 3391 (Washington DC)Investor Relations:Annabel Brownrigg-Gleeson +44 (0) 7901 101944 (London)James Dodwell +44 (0) 20 8047 2406 (London)Mick Readey +44 (0) 7990 339653 (London)Camilla Campbell +44 (0) 7803 050238 (London)Steph Mountifield +44 (0) 7796 707505 (London)Jeff McLaughlin +1 215 751 7002 (Philadelphia)Frannie DeFranco +1 215 751 4855 (Philadelphia) Sign in to access your portfolio
