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R.S.V. Vaccine Approved for Older Adults
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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
The vaccine, to be sold as Arexvy, appears to be the first in the world approved for sale to protect older adults from R.S.V., a potentially fatal respiratory illness.
Why It Matters: R.S.V. can be lethal
The F.D.A. estimates that R.S.V. is associated with 6,000 to 10,000 deaths each year in adults 65 and older and at least 60,000 hospitalizations in that age group. It is a leading killer of children worldwide.
This winter, R.S.V. contributed to the "tripledemic" also involving flu and Covid cases that swamped children's hospitals and some I.C.U. wards.
Announcing the approval, Dr. Peter Marks, the agency's vaccine division chief, said: "Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by R.S.V."
Background: Benefits and risks of the shots
On March 1, an F.D.A. advisory panel reviewed data from trials for two R.S.V. vaccines aimed at older adults, one from GSK and one from Pfizer. The panel recommended that the agency approve both.
The GSK vaccine was nearly 83 percent effective in preventing lower respiratory tract illness in adults 60 and older in a study of about 25,000 patients, according to data published in The New England Journal of Medicine. The virus can lead to pneumonia, which is far more worrisome for the elderly.
Pfizer's R.S.V. vaccine for older adults is also expected to receive F.D.A. approval this month. In a large study of that shot, it was found to be nearly 67 percent effective in preventing R.S.V.-related illness.
The Pfizer and GSK vaccines were even more effective in treating older and sicker patients.
The advisers did learn of some rare side effects from the vaccine trials. In the days after the shots were given, two recipients of the Pfizer vaccine and one recipient of the GSK shot developed cases of Guillain-Barré, a condition where the immune system attacks the nervous system, according to data presented to the F.D.A. panel.
Once the shots become available to the public, the agency said it would require GSK to monitor the incidence of Guillain-Barré and another rare condition that was possibly related to the shot.
Moderna is also developing an R.S.V. vaccine for this age group, and said it expected authorization in the first half of this year. A trial of 37,000 older adults showed 82 percent efficacy of its shot, the company said, with "no safety concerns identified" though analyses were continuing.
AstraZeneca and Sanofi are seeking F.D.A. approval of a monoclonal antibody treatment to protect infants and toddlers up to 2 years old from R.S.V. infections. Findings of a major study showed the therapy reduced confirmed illnesses by 75 percent after one shot, according to AstraZeneca.
Pfizer has applied for separate approval of an R.S.V. vaccine to be given in the later stages of pregnancy to protect young infants.
https://www.nytimes.com/2023/05/03/health/rsv-vaccine-fda-adults.html
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FDA News Release
FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
Arexvy Approved for Individuals 60 Years of Age and Older
For Immediate Release:
May 03, 2023
Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
"Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "Today's approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA's continued commitment to facilitating the development of safe and effective vaccines for use in the United States."
RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). According to the U.S. Centers for Disease Control and Prevention, each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine
03 May 2023
Issued: London, UK
For media and investors only
US FDA approves GSK's Arexvy, the world's first respiratory syncytial virus (RSV) vaccine for older adults
• Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
• The approval is based on data from the positive pivotal AReSVi-006 phase III trial that showed exceptional efficacy in older adults, including those with underlying medical conditions, and in those with severe RSV disease
• US launch is planned before the 2023/24 RSV season
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 GSK's 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
The US FDA approval is based on GSK's 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, 57.9-94.1, 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, 65.9-99.9, 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, 62.4-99.9, 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.
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.
https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-gsk-s-arexvy-the-world-s-first-respiratory-syncytial-virus-rsv-vaccine-for-older-adults/
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