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GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. This is the first RSV vaccine for older adults to be approved anywhere in the world.

Tony Wood, Chief Scientific Officer, GSK, said: Today marks a turning point in our effort to reduce the significant burden of RSV. Arexvy is the first approved RSV vaccine for older adults, expanding GSKs industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.

RSV is a common, contagious virus that can lead to potentially serious respiratory illness. It causes approximately 177,000 hospitalisations and an estimated 14,000 deaths in the US in adults aged 65 years and older each year.1,2,3 Older adults, including those with underlying medical conditions such as diabetes and chronic heart and lung disease, are at increased risk of severe RSV illness and drive the majority of RSV hospitalisations.4

John Kennedy, MD, President, American Medical Group Association (AMGA)added: For decades, AMGA and the healthcare community at large have been active in finding ways to increase adult immunisations. As a result, we are pleased that we can now add a respiratory syncytial virus vaccine to providers options for patient care. With this vaccine, Americans over the age of 60, and particularly those with underlying health conditions like COPD, asthma, or congestive heart failure, will have a vaccine to help protect against potentially serious outcomes from RSV.

The US FDA approval is based on GSKs landmark positive pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial data. In the trial, the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% (96.95% CI, 57.994.1, 7 of 12,466 vs 40 of 12,494) against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint. In addition, efficacy was 94.6% (95% CI, 65.999.9, 1 of 4,937 vs 18 of 4,861) in older adults with at least one underlying medical condition of interest, such as certain cardiorespiratory and endocrine-metabolic conditions. Efficacy against severe RSV-LRTD, defined as an RSV-associated LRTD episode preventing normal, everyday activities, was 94.1% (95% CI, 62.499.9, 1 of 12,466 vs 17 of 12,494).

The vaccine was generally well tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia. These were generally mild to moderate and transient.

In June 2023, the Advisory Committee on Immunization Practices (ACIP) will make recommendations on the appropriate use of the vaccine in the US. The vaccine will be available for older adults before the 2023/24 RSV season, which typically starts ahead of the winter months.

In April 2023, the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the vaccine for the prevention of LRTD caused by RSV in adults aged 60 years and older. A final European regulatory decision is anticipated in the coming months, while regulatory reviews are ongoing in Japan and several other countries.

About Arexvy (respiratory syncytial virus vaccine, adjuvanted)

Respiratory syncytial virus vaccine, adjuvanted, contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSKs proprietary AS01E adjuvant.

In the US, Arexvy is indicated for the prevention of RSV-LRTD in individuals 60 years of age and older. GSKs RSV older adult vaccine is not currently approved anywhere outside the US. The proposed trade name remains subject to regulatory approval outside the US.

A clinical trial that aims to expand the population who may benefit from RSV vaccination into adults aged 50-59, including participants with underlying comorbidities, is fully recruited. Results are expected in 2023, together with additional results from the AReSVi-006 phase III efficacy trial and the AReSVi-004 immunogenicity trial. These trials continue to evaluate an annual revaccination schedule and protection/immunogenicity over multiple seasons following one dose of the RSV vaccine. Results from two additional influenza vaccine co-administration trials are also expected before the June 2023 Advisory Committee on Immunization Practices (ACIP) meeting.

The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.

Please see the full US Prescribing Information: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF

About RSV in adults

RSV is a common contagious virus affecting the lungs and breathing passages. Older adults are at high risk for severe disease due in part to age-related decline in immunity, and older adults with underlying conditions are at even greater risk for severe disease. RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death. Each year, approximately 177,000 adults 65 years and older are hospitalised in the US due to RSV; an estimated 14,000 cases result in death.3 For adults 60 and older, data suggest an increased risk for severe RSV infection that can lead to hospitalisation.5,6 Adults with underlying conditions are more likely to seek medical services and have higher hospitalisation rates than adults without these conditions.

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 gsk.com/company.

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 under Item 3.D 'Risk factors in the company's Annual Report on Form 20-F for 2022, GSKs Q1 Results for 2023 and any impacts of the COVID-19 pandemic.

References

[1] Centers for Disease Control and Prevention. RSV Transmission. Accessed March 2023. Available at: https://www.cdc.gov/rsv/about/transmission.html

[2] National Foundation for Infectious Diseases. Respiratory Syncytial Virus in Older Adults: A Hidden Annual Epidemic. 2016. Accessed March 2023. Available at: https://www.nfid.org/wp-content/uploads/2019/08/rsv-report.pdf

[3] Falsey AR, et al. N Engl J Med 2005; 352:1749-1759 DOI: 10.1056/NEJMoa043951. Accessed March 2023.

[4] Centers for Disease Control and Prevention. RSV in Older Adults and Adults with Chronic Medical Conditions. Accessed March 2023. Available at: http://www.cdc.gov/rsv/high-risk/older-adults.html

[5] Tseng HF, Sy LS, Ackerson B, et al. Severe morbidity and short- and mid- to long-term mortality in older adults hospitalized with respiratory syncytial virus infection. J Infect Dis. 2020;222(8):1298-1310. doi:10.1093/infdis/jiaa361.

[6] Belongia EA, King JP, Kieke BA, et al. Clinical features, severity, and incidence of RSV illness during 12 consecutive seasons in a community cohort of adults 60 years old. Open Forum Infect Dis. 2018;5(12):ofy316. doi:10.1093/ofid/ofy316.

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US FDA approves GSKs Arexvy, the worlds first respiratory ... - GSK

Cambridge head coach Mark Bonner was frustrated after his side missed the chance to keep their fate in their own hands on the final day of the League One campaign.

The 1-0 defeat to Burton left Bonners side needing both MK Dons and Morecambe to drop points on the last day to have any chance of staying up.

We wanted to go into Sunday with it in our control and it isnt, Bonner said.

We have to respond and win our game firstly and hope other things go for us. Tonight is disappointing because of the opportunity we had to put it in our own hands.

But if we are being honest six weeks ago we would have taken being in it on the last day.

Burtons Mark Helm scored the only goal with a deflected effort and Bonner felt his side contributed to their own downfall.

He added: Their goal came off our own poor play and there are a few teams in the league you dont want to go behind to and they are certainly one of them.

Burton had a few good chances and will say they should have killed the game off, but they didnt so we were always in the game.

Striker Sam Smith thought he had equalised late on with a header saved by Burton goalkeeper Jordan Amissah, with Bonner unsure whether the ball had crossed the line.

Either that is the best save Ive ever seen or the ball has crossed the line, Bonner said.

I dont know which but everyone was celebrating as if it had (crossed the line). Tough to see on the video and the replays but the shape of it looked like it had.

With safety already secured Albion boss Dino Maamria was a happy man as his side reached a season-high 14th spot going into the final game.

I thought it was a very good performance throughout, Maamria said.

We played some good football and got the balance right. We controlled the middle of the park. We scored one and could easily have got two or three.

Maamria praised goalkeeper Amissah, making his first start since January, but reserved his top praise for match-winner Helm, who is finishing the season in really good form having joined from Burnley in January.

He added: Jordi deserved his start. Although he hasnt played, he has been a huge part of what we have been doing and getting that clean sheet is testament to him.

John Brayford and Sam Hughes were superb at the back but what about Mark Helm? What a performance that is. He is a top, top player. He showed what he is capable of, and he is getting better and better.

All in all, lots of positives tonight. We are getting better and better all the time.

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Mark Bonner disappointed as Cambridge lose control of their ... - Kalkine Media

Known to many as both the best hometown in the Army and the intellectual center of the Army, Fort Leavenworth is famous for being the home of the U.S. Armys Combined Arms Center, the U.S. Army Command and General Staff College, also known as the CGSC, and many other prestigious tenants. While possibly lesser-known than some of the other notable tenants at Fort Leavenworth, the installations own Sherman Army Airfield is no less significant.

As a joint-use facility, the airfield is an important feature to civilians and military alike. Unfortunately, after the historic 2019 Missouri River flood, the airfield was devastated. In response, the U.S. Army Corps of Engineers, Kansas City District has been working to make repairs and design mitigation measures to prevent future flood damage to the airfield.

History

Flooding in this area happens every few years, with several memorable years being 1951, 1993 and 2011. During the 2019 flood, floodwaters breached the levee and completely submerged the entire airfield. Mark Martinez, an office engineer at the Fort Leavenworth resident office, remembers the flood vividly.

When the flood waters subsided, there were snakes in the rafters of the hangar, he said.

There are still high-water marks visible on the walls of the hanger, a remaining sign of the devastating damage. At that time, the pumps at the airfield did not have the capacity to clear the amount of water that had come in. This forced Public Works to take the only way forward.

The only way they could get rid of the water was to cut the levee and let the water flow out after the water had dropped down, Billy Summers, airfield manager, said. That was the only option they had.

Project Scope

Contract work on the airfield has included demolition, levee repairs, water control structures and more. Val Guillen, a project engineer at the site, outlined the scope of the job.

The work includes repairs to civil infrastructure damage within the airfield and surrounding levee system at Fort Leavenworth that occurred as a result of [the flood], he said.

The main focus of the project, though, has been the design and construction of two pump stations.

These new pumps its a lot more power [than the old ones], Guillen said.

The pumps function through sensory control. When flood waters begin to rise, the initial phase will simply use gravity to let the water flow back into the river. Once the water rises to the initial sensor, a lead pump will kick in, followed by two secondary pumps if floodwaters continue to increase.

Impact

The 2019 flood not only impacted military use of the airfield, which includes Chinook helicopters, prison transfers and medical emergencies, but the local communitys use as well. The airfields main clients are distinguished visitors that fly into Fort Leavenworth to visit the CGSC, as well as major companies that have business in downtown Leavenworth, Kansas. It is important to the installation to be able to continue to provide the airfield as a service to these visitors, Guillen explained.

Even beyond military, commercial and recreational use, the need for flood prevention on the airfield reaches everyone who lives and works on Fort Leavenworth. Located near the airfield are the water wells which provide potable water for the whole installation. During the 2019 flood, those wells were submerged, preventing Fort Leavenworth from supplying their own water like usual.

When those pumps were underwater, we couldnt get our potable drinking water or flushing water or any other kind of water, said Travis Schuler, a construction control representative for the project.

The installation had to buy water from the City of Leavenworth, Kansas, costing the installation additional money. Not being able to sustain themselves was a major concern, the project team explained.

Additionally, the airfield is a noteworthy piece of U.S. Army heritage. It is home to one of the only two flying clubs left on U.S. Army installations nationwide. These clubs give retirees and other eligible members the opportunity to get their pilot licenses and instrument ratings. The public are also able to keep aircraft there.

The team has high hopes for the future of the airfield and envision that one day the flying club might get a better office inside the hangar and that updates to the landing strip and runway will improve the overall experience for those who use the airfield.

The original contract work on the project is nearly finished. The new pumps are in the final stages of testing. The contractor for this project is Radmacher Brothers Excavating Company Inc. They were awarded the contract in September2020.

The project is expected to be completed by the end of calendar year 2023.

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Stopping the Breach: Kansas City District Engineers work to prevent ... - nwk.usace.army.mil

New research into our immune system opens the door to new treatment that could prevent runaway inflammation in patients with severe COVID-19.

Macrophages are one of the most important cells of the immune system. While they play a central role in defending the human body against infection, they can also contribute to the excessive inflammation that characterises severe COVID-19 infections, and may also help facilitate viral replication and spread throughout the body.

In a study published in Science Signaling, scientists from the University of Queenslands Institute for Molecular Bioscience (IMB) and the Peter Doherty Institute for Infection and Immunity (Doherty Institute) took a deep dive in the immune system to understand how macrophages interact with the SARS-CoV-2 virus.

They discovered that most macrophages are not infected with the virus. In fact, instead of triggering a protective, anti-viral response to eliminate the virus, uninfected macrophages detect damage and death in neighbouring cells and trigger a strong inflammatory response resulting in widespread inflammation.

The University of Queensland Dr Larisa Labzin, first author of the study, said that the problem is we end up with too many immune cells coming to the site of infection causing a whole lot of collateral damage too much inflammation and not enough virus fighting.

It's a double-edged sword for the body: the immune system tackling an infectious disease early on is protective, but when it's prolonged or excessive, it can really drive chronic inflammation, Dr Labzin explained.

The University of Melbourne Dr Sarah Londrigan, Laboratory Head at the Doherty Institute and joint senior author of the research, said that this study reveals key differences in our immune response to SARS-CoV-2 compared to other respiratory viruses like influenza A virus.

This finding that most macrophages (immune cells) are not infected with SARS-CoV-2 is in direct contrast to our ongoing studies with influenza A virus, which is able to infect these cells very well, Dr Londrigan said.

This information is another piece in the puzzle towards understanding why some respiratory viruses cause such severe disease.

With the new understanding of how macrophages recognise and respond to the virus, researchers are investigating new therapeutic strategies to reduce the incidence of severe COVID.

Anti-inflammatory drugs are currently given to patients hospitalised with COVID-19 after the virus has peaked, to calm down the overactive immune response but the drugs make patients susceptible to secondary infections.

The key will be to develop treatment targeting macrophages without compromising the bodys ability to fight against the virus, like anti-inflammatories that can be administered earlier, to prevent inflammation getting out of control.

The University of Queensland Professor Kate Schroder, joint senior author of the paper, said understanding more of the fundamental biology behind the immune system will help us help our bodies fight more strongly against infections.

We have vaccines and anti-virals in the fight against COVID-19 but the virus keeps mutating, so this is a way to future-proof ourselves against new variants and also future pandemics and infections.

Dr Londrigan concluded that, while this work is the fruit of collaboration with the University of Queenslands IMB and the Doherty Institute, other teams also played a crucial role in this research.

I really want to acknowledge the important and ongoing collaborations between miney and Professor Kanta Subbaraos teams with Associate Professor Daniel Steinfort and colleagues at the Royal Melbourne Hospital.

Originally posted here:
Researchers uncover the key to fighting out of control inflammation ... - The Peter Doherty Institute for Infection and Immunity

Portland, Ore. --

After a historically dry start to the refill season, water managers with the Portland District, U.S. Army Corps of Engineers (Corps) are now optimistic about refilling most Willamette Valley reservoirs after increased rainfall and snowmelt in April.

To help explain the nuances of this water year, including refill and the conservation forecast, Corps staff will host a virtual public information session May 10, noon to 1 p.m., and May 11, 5-6 p.m.

The last few years have been a hydrologic roller coaster, and this year is no exception, said Salina Hart, the Portland District chief of the Reservoir Regulation andWater Quality Section. Spring rains are essential for refilling reservoirs and fortunately, we saw a substantial improvement in April.

The Corps reports the Willamette Valley system of dams and reservoirs is 62% full as of May 2.

Weather is one critical factor among a host of other criteria that influence the way the Corps approaches water management in the Willamette Valley system.

In February, water managers begin the delicate dance of balancing the many Congressional purposes of both the reservoirs and the dams that impound them.

One primary purpose of the systems dams and reservoirs is flood risk management: Water managers must keep reservoir elevations low to maintain storage space in the reservoirs through the spring to capture seasonal rains and prevent flooding downriver. This must be balanced with what sometimes seems to be conflicting purposes: refilling the reservoirs for irrigation, hydropower generation, water quality improvement and recreation.

The balancing act doesnt end there: The Corps must also meet minimum water releases according to the requirements of the 2008 Biological Opinions, which define minimum releases, or beneficial flows, from the reservoirs to improve downstream habitat for endangered species.

Additionally, this year, water managers will continue to operate under the constraints of a 2021 court injunction that aims to improve conditions for endangered species. The injunction orders have called on the Corps to delay reservoir refills this spring at Cougar and Fall Creek and begin early fall drawdowns of the reservoirs at Lookout Point and Green Peter, which will impact recreational access at all those reservoirs as the reservoirs release water sooner to provide fish passage.

Water managers forecast that Foster Lake will remain full for Memorial Day through Labor Day. Several smaller reservoirs are currently full or nearing full levels. The remaining larger reservoirs, which are seeing improvement given the April rainfall and some snowmelt, are expected to fill, although later than typical. Reservoir refill levels for the Willamette Valley can be found at https://www.nwd-wc.usace.army.mil/nwp/teacup/willamette/

The Corps invites the public to attend the session to learn more about current operations, future forecasts, and potential impacts to the Willamette Valley System.

Date: Wednesday, May 10, noon to 1 p.m., and Thursday, May 11, 5-6 p.m.

Link:https://usace1.webex.com/meet/erik.s.petersen

Call: 1-844-800-2712 (US) (Call-in toll-free number)

Access Code: 1999-18-2318 #

The Corps encourages questions during the meeting and asks participants to either send questions using the chat function in WebEx during the virtual meeting or email the Portland District Public Affairs Office ahead of the meeting at cenwp-pa@usace.army.mil.

Willamette Valley Project water year overview:Year-to-date precipitation across the Willamette was 92% of median, as of May 2. The snowpack is 236% of median (24 inches) for the Willamette. Snowmelt accounts for less than 10% of refill in the system and helps keep reservoir elevations up in the summer but only if the inflow of the snowmelt to the reservoir matches outflows from the reservoir. This year, given the late season melt, reservoirs that do have heavier snowmelt influence, like Detroit, will see additional refill benefit.

The Corps manages reservoir inflows based on a water control diagram, more commonly called the rule curve, which is the authorized maximum elevation on a given day to balance flood risk management and storage for other authorized purposes, such as recreation, hydropower, and irrigation supply. The Willamette Valley Systems reservoirs are kept lower in the winter to reduce downstream flooding and are refilled in the spring to prepare for recreation and adequate flows for Endangered Species Act compliance and water quality.

Portland District encourages the public to check its teacup diagrams before heading out to recreate. These diagrams show water elevations for Corps-managed reservoirs:https://www.nwd-wc.usace.army.mil/nwp/teacup/willamette/orhttp://pweb.crohms.org/nwp/teacup/willamette/.

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Corps to provide update on Willamette Valley reservoirs ahead of ... - nwp.usace.army.mil