Respiratory syncytial virus vaccine

GSK’s RSV Vaccine, AREXVY, Accepted Under Priority Review in US for the Prevention of RSV Disease in Adults Aged 50-59 at Increased Risk

Retrieved on: 
Tuesday, February 6, 2024
Research, Infectious Diseases, Seniors, FDA, Clinical Trials, Biotechnology, Pharmaceutical, Consumer, Health, Science, GSK plc, Chronic obstructive pulmonary disease, Pneumonia, Respiratory syncytial virus vaccine, Safety, Hospital, US FDA, Ageing, Priority review, Food, COPD, Risk, RSV, Respiratory syncytial virus, Asthma, GSK, Pharmaceutical industry

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted under Priority Review an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease.

Key Points: 
  • GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted under Priority Review an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease.
  • If approved, GSK’s RSV vaccine would be the first vaccine available to help protect this population.
  • AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is currently approved in the US in adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV.
  • GSK used a Priority Review Voucher to reduce the US FDA review period of a supplemental Biologics License Application (sBLA) by four months.

New Data for AREXVY, GSK’s RSV Vaccine, Show Potential to Help Protect Adults Aged 50 to 59 at Increased Risk for RSV Disease

Retrieved on: 
Wednesday, October 25, 2023
Seniors, Biotechnology, Pharmaceutical, Health, FDA, Infectious Diseases, Consumer, Clinical Trials, RSV, COPD, Headache, Ageing, Food, Respiratory syncytial virus vaccine, III, Conditional sentence, US Foods, Safety, Heart, Diabetes, Stockholm Environment Institute US Center, Infection, Pneumonia, Chronic kidney disease, CDC, Chronic liver disease, Risk, Asthma, ACIP, GSK plc, GSK, Hospital, Pain, Chronic obstructive pulmonary disease, Fatigue, Vaccine, Pharmaceutical industry, Adjuvant

The vaccine elicited an immune response in adults aged 50 to 59 at increased risk for RSV disease due to select underlying medical conditions that was non-inferior to that observed in adults aged 60 and above, meeting the trial’s primary co-endpoint.

Key Points: 
  • The vaccine elicited an immune response in adults aged 50 to 59 at increased risk for RSV disease due to select underlying medical conditions that was non-inferior to that observed in adults aged 60 and above, meeting the trial’s primary co-endpoint.
  • The co-primary endpoint was also met for the broader group of adults aged 50 to 59 also enrolled in the trial.
  • Tony Wood, Chief Scientific Officer, GSK, said: “This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD.
  • Immune response in participants aged 50 to 59 with pre-defined stable chronic diseases leading to an increased risk of RSV disease was assessed (n=570).

Bioxytran Announces Broad Spectrum Antiviral Activity Highlighted in ProLectin-M

Retrieved on: 
Thursday, September 14, 2023
SARS-CoV-2, COVID-19, Article, Mutation, Viral, COVID, Respiratory syncytial virus vaccine, RSV, Lower respiratory tract infection, Viral load, Virus, Complex, Vaccine, H1N1

ProLectin-M (“PL-M”) and ProLectin-I were the galectin antagonists used on these 3 viruses to produce the results set forth in the Article.

Key Points: 
  • ProLectin-M (“PL-M”) and ProLectin-I were the galectin antagonists used on these 3 viruses to produce the results set forth in the Article.
  • The in vitro data demonstrates that PL-M has the potential to be a broad-spectrum antiviral useful in the treatment of Upper Respiratory Infections (“URI”).
  • Additionally, the existing antiviral treatment options have seen the first signs of resistance calling into question their long-term viability.
  • PL-M is a next generation antiviral that is designed to prevent the virus from entering the cell.

U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age

Retrieved on: 
Monday, August 21, 2023
Infectious Diseases, FDA, Pharmaceutical, Health, Aurora, Inc., Pregnancy, University, Senior, Life, Hospital, Gestational age, Public, Safety, The New England Journal of Medicine, Infection, PFE, Clinical trial, Children's Hospital Colorado, University of Colorado School of Medicine, Development, Protein, RSV, Risk, Respiratory syncytial virus vaccine, Immunization, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, Vaccine, Pfizer

ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.

Key Points: 
  • ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.
  • “We are incredibly grateful to the clinical trial participants and study investigator teams around the world, as well as our Pfizer colleagues, for their commitment to making this vaccine available.
  • These results were published in The New England Journal of Medicine in April 2023.
  • Simões, M.D., Clinical Professor, Pediatrics-Infectious Diseases, University of Colorado School of Medicine and Children’s Hospital Colorado, Aurora.

FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

Retrieved on: 
Monday, August 21, 2023
Vaccine, China Biologic Products, Priority review, Bronchiolitis, Pregnancy, Pre-eclampsia, Urinary tract infection, Life, U.S. Department of Commerce Office of Security, Hospital, Gestational age, Human services, Public, Office of Inspector General, U.S. Department of Health and Human Services, Center for Biologics Evaluation and Research, Food, Pfizer, Cosmetics, Multimedia, Respiratory syncytial virus, Animal, Trial of the century, Pain, Myalgia, Jaundice, RSV, Dietary supplement, Risk, Hypertension, Korea Disease Control and Prevention Agency, Preterm birth, Nausea, Infant, Heated tobacco product, Respiratory syncytial virus vaccine, Research, FDA, Immunization, Headache, Regulation of tobacco by the U.S. Food and Drug Administration, Pneumonia, Safety, Birth control, Pharmaceutical industry

The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age and older.

Key Points: 
  • The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age and older.
  • "This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease."
  • In one study, approximately 3,600 pregnant individuals received a single dose of Abrysvo and approximately 3,600 pregnant individuals received a placebo.
  • In the second study, approximately 100 pregnant individuals received Abrysvo and approximately 100 pregnant individuals received placebo.

GSK Announces AREXVY, Its Respiratory Syncytial Virus (RSV) Vaccine, Is Now Available at All Major US Retail Pharmacies

Retrieved on: 
Thursday, August 17, 2023
Seniors, Pharmaceutical, General Health, Health, FDA, Health Insurance, Consumer, Other Health, Vaccine, ACIP, GSK, Senior, Diabetes, Vaccination, Pharmacy, Advisory Committee, Multimedia, Person, Medicare Part D, Medicare, Inflation, Death, GSK plc, RSV, Affordable Care Act, Patient, Advisory Committee on Immunization Practices, Risk, Ageing, Inflation Reduction Act of 2022, Respiratory syncytial virus vaccine, Care Act 2014, Health insurance

GSK plc (LSE/NYSE: GSK) today announced that AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is now available in the US at all major retail pharmacies.

Key Points: 
  • GSK plc (LSE/NYSE: GSK) today announced that AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is now available in the US at all major retail pharmacies.
  • Shared clinical decision making empowers patients, in consultation with their healthcare providers, to decide whether RSV vaccination is appropriate for them.
  • AREXVY is indicated for the prevention of RSV-lower respiratory tract disease (LRTD) in individuals aged 60 years and older.
  • Rob Truckenmiller, Senior Vice President, Head of US Vaccines, GSK, said: “We are excited to announce that AREXVY is now available to older adults in major retail pharmacies across the US ahead of this year’s RSV season.

RSV is everywhere right now. What parents need to know about respiratory syncytial virus

Retrieved on: 
Wednesday, July 26, 2023
Vaccine, Finswimming at the 2022 World Games – Women's 50 m apnoea, Allergy, Bronchiolitis, Asthma, US Foods, Wheeze, Parent, Infection, Fever, Respiratory syncytial virus vaccine, Immunity, GP, COVID, Appetite, Cough, Palivizumab, RSV, Hospital, Risk, Place of birth, Child, Immune system, Sneeze, First Nations, Infant, Ageing, Pregnancy, Health, FDA, Safety, Virus, Irritability, Pneumonia, Pfizer, Disease, Birth control

This winter, we’re having to get our heads around another respiratory virus – RSV.

Key Points: 
  • This winter, we’re having to get our heads around another respiratory virus – RSV.
  • It’s less well known than COVID or flu, but it’s also responsible for unplanned visits to the GP or emergency department, and days off school, childcare and work.

What is RSV?

    • This common respiratory virus usually causes a mild cold with symptoms such as a fever, runny nose, coughing, decreased appetite and a wheeze.
    • Adults can be infected infected with RSV but usually recover in a few days.
    • But in young babies RSV can cause more severe respiratory illnesses such as pneumonia or bronchiolitis.

Who’s most at risk?

    • First Nations children are three to six times more likely to be hospitalised with bronchiolitis caused by RSV than non-First Nations children.
    • Otherwise healthy children under 12 months old (usually under six months old) are the ones most often admitted to hospital.

Why are we seeing so many cases now?

    • But measures earlier in the COVID pandemic limited the spread of RSV.
    • However, many states are experiencing a winter surge in cases and hospitalisations attributed to it this year – bigger than before the pandemic.
    • However, reduced immunity in young infants due to lower maternal and infant exposure may have contributed to the record number of cases.

Is there a vaccine?

    • Australia’s only currently available preventative medicine is palivizumab, which is a long-acting monoclonal antibody given monthly during the RSV season.
    • Due to its cost, it is reserved for infants at highest risk for severe RSV infection and is usually given in hospital.
    • In May this year, the US Food and Drug Administration approved the RSV vaccine Arexvy for people aged 60 and over.

How can I protect my children in the meantime?

    • Encourage children to cover their mouths and noses when coughing or sneezing, and regularly wash their hands.
    • Ensuring kids stay away from school, childcare or other children when sick helps prevent the spread of many viruses, including RSV.
    • If parents notice these signs or are worried about their child they should seek urgent medical assessment and not delay.

US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices votes to recommend AREXVY for the prevention of RSV disease in adults aged 60 and older with shared clinical decision making

Retrieved on: 
Thursday, June 22, 2023
Research, Infectious Diseases, FDA, Seniors, Biotechnology, Health, Consumer, Pharmaceutical, Science, ACIP, GSK, The New England Journal of Medicine, US Foods, Respiratory syncytial virus vaccine, Diabetes, Vaccination, United States Department of Health and Human Services, Season, Chronic lung disease, DSM-IV codes, Multimedia, Morbidity and Mortality Weekly Report, CDC, Death, GSK plc, RSV, State, Patient, Risk, MMWR, Stockholm Environment Institute US Center, Kidney, Ageing, Disease, III, Food, Vaccine, Poultry farming

GSK plc (LSE/NYSE: GSK) today announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of AREXVY (respiratory syncytial virus vaccine, adjuvanted) in adults aged 60 and older using shared clinical decision making.

Key Points: 
  • GSK plc (LSE/NYSE: GSK) today announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of AREXVY (respiratory syncytial virus vaccine, adjuvanted) in adults aged 60 and older using shared clinical decision making.
  • Shared clinical decision making empowers patients in consultation with their healthcare providers to determine whether RSV vaccination is appropriate for them.
  • These data will be submitted to the US Food and Drug Administration (FDA) for review.
  • The ACIP recommendations will be forwarded to the director of the CDC and the US Department of Health and Human Services for review and approval.

U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults

Retrieved on: 
Wednesday, May 31, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Infectious Diseases, Clinical Trials, Vaccine, ACIP, Inc., Asthma, University, Senior, The New England Journal of Medicine, PFE, Clinical trial, University of Rochester Medical Center, CDC, Chronic obstructive pulmonary disease, Development, Protein, RSV, MD, Immunodeficiency, Respiratory syncytial virus vaccine, Regulation of tobacco by the U.S. Food and Drug Administration, Safety, NYSE, Food, Pfizer

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older.
  • “A vaccine to help prevent RSV had been an elusive public health goal for more than half a century.
  • “ABRYSVO will address a need to help protect older adults against the potentially serious consequences of RSV disease.
  • RENOIR is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccinein adults 60 years of age and older.

US FDA Approves GSK’s AREXVY, the World’s First Respiratory Syncytial Virus (RSV) Vaccine for Older Adults

Retrieved on: 
Wednesday, May 3, 2023
Science, Seniors, Research, Health, FDA, Infectious Diseases, Consumer, Other Health, ACIP, COPD, GSK, US Foods, Respiratory syncytial virus vaccine, Asthma, Diabetes, Heart, Advisory Committee, CI, European Directive on Traditional Herbal Medicinal Products, Multimedia, Infection, Arthralgia, Respiratory syncytial virus, AMGA, Death, GSK plc, RSV, Myalgia, MD, American Medical Group Association, Advisory Committee on Immunization Practices, Risk, Ageing, European Medicines Agency, Headache, III, Food, Fatigue, CHMP, Vaccine, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • AREXVY is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year.
  • As a result, we are pleased that we can now add a respiratory syncytial virus vaccine to providers’ options for patient care.