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FDA Approves Arexvy (respiratory syncytial virus vaccine, adjuvanted) Respiratory Syncytial Virus (RSV) Vaccine for Older Adults
May 3, 2023 -- 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 hospitalizations 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 hospitalizations.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 immunizations. 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 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.
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 Agency’s 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 GSK’s proprietary AS01E adjuvant.
In the US, Arexvy is indicated for the prevention of RSV-LRTD in individuals 60 years of age and older. GSK’s 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.
Important Safety Information for Arexvy
The following is based on the US Prescribing Information for Arexvy. Please consult the full Prescribing Information for all the labelled safety information.
- Do not administer Arexvy to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of Arexvy.
- Appropriate medical treatment and supervision must be available to manage possible 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.
- The most commonly reported (≥10%) adverse reactions were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%).
- Vaccination with Arexvy may not result in protection of all vaccine recipients.
About RSV in older 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, hospitalization, and death. Each year, approximately 177,000 adults 65 years and older are hospitalized 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 hospitalization.5,6 Adults with underlying conditions are more likely to seek medical services and have higher hospitalization rates than adults without these conditions.
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, GSK’s Q1 Results for 2023 and any impacts of the COVID-19 pandemic.
- Centers for Disease Control and Prevention. RSV Transmission. Accessed March 2023. Available at: https://www.cdc.gov/rsv/about/transmission.html
- 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
- Falsey AR, et al. N Engl J Med 2005; 352:1749-1759 DOI: 10.1056/NEJMoa043951. Accessed March 2023.
- Centers for Disease Control and Prevention. RSV in Older Adults and Adults with Chronic Medical Conditions. Accessed March 2023. Available at: www.cdc.gov/rsv/high-risk/older-adults.html
- 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.
- 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.
Posted: May 2023
Arexvy (respiratory syncytial virus vaccine, adjuvanted) FDA Approval History
Is RSV vaccine FDA approved? ›
Yesterday, the Food and Drug Administration announced the approval of the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. The vaccine, Arexvy, is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.Is there an RSV vaccine for adults? ›
The U.S. Food and Drug Administration (FDA) approved the first respiratory syncytial virus (RSV) vaccine last week. Manufactured by GlaxoSmithKline, Arexvy has been approved for adults 60 years and older.Should seniors get RSV vaccine? ›
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.When will RSV vaccine be available for older adults? ›
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.How much does Arexvy cost? ›
GSK's shot, called Arexvy, is cleared only for use in adults 60 years or older. The company has not yet disclosed a specific price, but executives have previously indicated they will charge between $60 and $185 a dose, around what vaccines for influenza and shingles cost.Who should get RSV vaccine? ›
Q: Who should get the RSV vaccine? A: Anyone 65 and older with any kind of lung disease, heart disease or other underlying conditions that may cause them to have problems when they get an infection should consider getting the RSV vaccine.Why don t they have a RSV vaccine? ›
Developing RSV vaccines has historically been difficult because the main protein on the outside of the virus, called the F protein, changes shape when it infects cells. The most effective antibodies, either natural or factory-made, target a part of this protein that is only exposed before this shape change.Why did the RSV vaccine fail? ›
Most notably, the adjuvants strongly activated type 1 T-helper (Th1) responses, which are essential in defending against viruses. These responses have been hard to stimulate in newborns. In fact, a major reason the earlier RSV vaccine failed was that it did not produce a Th1 response.Is the RSV vaccine safe? ›
In a two-part vote, the experts voted unanimously, 14-0, that the available data support the effectiveness of the Pfizer vaccine in preventing severe RSV-related respiratory illness. They then voted 10-4 that the data supports the vaccine's safety. RSV is a leading cause of infant hospitalization in the U.S.Can adults and seniors get RSV? ›
Each year, it is estimated that between 60,000-160,000 older adults in the United States are hospitalized and 6,000-10,000 of them die due to RSV infection. Adults at highest risk for severe RSV infection include: Older adults, especially those 65 years and older. Adults with chronic heart or lung disease.
What does RSV do to older adults? ›
Symptoms of RSV
Particularly in older adults and other vulnerable populations, RSV can cause more acute symptoms, such as wheezing and difficulty breathing, can lead to such severe illnesses as bronchiolitis and pneumonia, and can exacerbate conditions such as asthma and chronic obstructive pulmonary disease (COPD).
Older adults are at greater risk than young adults for serious complications from RSV because our immune systems weakens when we are older. There is no vaccine to prevent RSV infection yet, but scientists are working hard to develop one. If you are concerned about your risk for RSV, talk to your doctor.How long is the RSV vaccine good for? ›
So far, GSK found that protection from a single vaccination protects older people through an entire respiratory disease season, and potentially up to a year.What are the side effects of the RSV shot? ›
The most common side-effects are fever, irritability, or redness at the injection site.” The benefits of up to an 80% reduction for preemies in the number of hospitalizations for RSV, after Synagis® preventative treatment, far outweigh the risks of the medication.Is the RSV vaccine a live vaccine? ›
Live-attenuated respiratory syncytial virus (RSV) vaccines offer several advantages for immunization of infants and young children: (1) they do not cause vaccine-associated enhanced RSV disease; (2) they broadly stimulate innate, humoral, and cellular immunity, both systemically and locally in the respiratory tract; (3 ...What is the high risk RSV vaccine? ›
SYNAGIS should be given to high-risk babies every 28-30 days during RSV season. Talk to your doctor about a dosing schedule appropriate for your area. It's important that babies at high risk for severe RSV disease get every injection of SYNAGIS on time throughout the RSV season.Who is RSV worst for? ›
RSV can cause severe infection in some people, including babies 12 months and younger (infants), especially premature infants, older adults, people with heart and lung disease, or anyone with a weak immune system (immunocompromised).Is the Pfizer RSV vaccine approved? ›
There is currently no FDA-approved RSV vaccine, but after nearly five decades of vaccine-development efforts, researchers are on the cusp of approval. Edward Walsh, MD, professor of Medicine, has a long history with Pfizer, working on multiple viral pathogens over the years.How much do Synagis shots cost? ›
Each 50 mg single-dose vial of Synagis liquid solution contains 50 mg of palivizumab and also contains chloride (0.2 mg), glycine (0.06 mg), and histidine (1.9 mg), in a volume of 0.5 mL. Palivizumab is a recombinant humanized monoclonal antibody with anti-RSV activity [see Microbiology (12.4)].
Has the RSV vaccine trial stopped? ›
GlaxoSmithKline (GSK) last year stopped a late-stage clinical trial of its RSV vaccine in pregnant people over an elevated risk of premature birth and associated neonatal deaths in the babies born prematurely. In the GSK trial, premature birth was 38% more likely in the vaccinated pregnancies than in the placebo group.Why is RSV called syncytial? ›
Its name is derived from the large cells known as syncytia that form when infected cells fuse. RSV is the single most common cause of respiratory hospitalization in infants, and reinfection remains common in later life: it is a notable pathogen in all age groups.What does RSV look like in adults? ›
Usually, as an adult, when you become ill with RSV you have mild cold-like symptoms such as a runny nose, sore throat, cough and a headache. But sometimes, and for some people, you can become so ill you need to be hospitalized. And each year in the United States thousands of older adults die of complications from RSV.What is the oldest case of RSV? ›
RSV was discovered in 1956 but was not initially associated with respiratory illness among infants. Indeed, when a group of 14 chimpanzees were noted to be suffering from colds and coryza, Morris and co-workers10 isolated a new virus originally named chimpanzee coryza agent (CCA).Has there ever been a vaccine for RSV? ›
Respiratory syncytial virus vaccine, or RSV vaccine, is a vaccine which prevents infection by respiratory syncytial virus. The first RSV vaccine sold under the brand name Arexvy, and developed by GSK was approved for medical use in the United States in May 2023 for people age 60 and older.Is my child vaccinated against RSV? ›
There is no vaccine yet to prevent RSV infection, but scientists are working hard to develop one. And there is a medicine that can help protect some babies at high risk for severe RSV disease.How do you get rid of RSV in older adults? ›
Even without major health complications, older adults may need more time than younger people to get over RSV. As with cold viruses, there is no specific medication or other treatment for RSV. The usual advice to rest and get plenty of fluids still applies.Can adults under 60 get RSV? ›
But you can get it at any age. And if you're older than 60, you're at even greater risk for RSV. “The virus is increasingly recognized as a significant cause of respiratory illness in older adults in the U.S.,” says William Schaffner, MD, medical director of National Foundation of Infectious Diseases.What is the fastest way to get rid of RSV in adults? ›
Most RSV infections go away on their own in a week or two. There is no specific treatment for RSV infection, though researchers are working to develop vaccines and antivirals (medicines that fight viruses).Is COVID like RSV? ›
The flu, COVID-19, and respiratory syncytial virus (RSV) are all highly contagious respiratory infections caused by viruses: The flu by influenza virus, COVID-19 by SARS-CoV-2 virus, and RSV by respiratory syncytial virus. It is possible for a person to be infected with multiple viruses at the same time.
Can adults have RSV and not know it? ›
Because RSV symptoms resemble those of the common cold (runny nose, sore throat, mild headache, cough, and sometimes a fever), parents and other adults may not realize they are infected with the virus but can still be contagious.How long does RSV last in adults over 65? ›
RSV symptoms in adults
It can look like a common cold and include runny nose, decreased appetite, coughing, sneezing, fever and wheezing. The symptoms typically last a week or two, and they clear up with rest and fluids.
What are the symptoms of RSV in adults? Typical symptoms include a cough, sore throat, congestion, runny nose, headache, mild fevers, and fatigue.How contagious is RSV in adults? ›
People infected with RSV are usually contagious for 3 to 8 days and may become contagious a day or two before they start showing signs of illness.Does RSV give lifelong immunity? ›
This happens because getting sick with RSV doesn't trigger a lasting immune response. So getting sick with RSV doesn't give you much protection against future illnesses. And even if you do form antibodies against RSV, studies show these antibodies don't offer complete protection.Is RSV immunity lifelong? ›
RSV is a common respiratory virus that causes cold-like symptoms in children and adults. Adults 65 and over and adults with chronic conditions or weakened immune systems are at high risk for developing severe RSV. People do not form long-lasting immunity to RSV and can become infected repeatedly over their lifetime.Does immunity to RSV last? ›
Additionally, RSV infections only provide partial immunity, and individuals remain susceptible to repeat infections throughout their lives.What are the risks of vaccines? ›
Vaccines do have some risk for adverse reaction, the most common being redness and soreness at the injection site or fever and allergic reactions.What is the status of RSV vaccine? ›
RSV Vaccines Approved 2023
AREXVY™ RSV OA (GSK3888550A) is an approved single-dose RSV vaccine (BLA 125775) for adults aged 60 and above. The FDA voted in favor of the approval of this vaccine on March 1, 2023. In addition, the EMA issued a positive opinion on April 26, 2023.
Pfizer ABRYSVO™ RSVpreF RSV Vaccine May 2023
Pfizer Inc.'s ABRYSVO™ RSVpreF (PF-06928316) bivalent prefusion F subunit vaccine candidate is based on the crystal structure of prefusion F, a vital form of the viral fusion protein (F) that respiratory syncytial virus (RSV) uses to attack human cells.
How effective is the RSV vaccine? ›
In an RSV challenge study involving healthy persons who were 18 to 50 years of age, the vaccine efficacy was 87% (95% confidence interval [CI], 54 to 96) against symptomatic RSV infection confirmed by any detectable viral RNA on at least 2 consecutive days.Is RSV vaccine available? ›
The US Food and Drug Administration has approved a vaccine against the respiratory syncytial virus, or RSV, for adults 60 and older. This vaccine, called Arexvy, is made by the drug company GSK.Is Pfizer making a vaccine for RSV? ›
Pfizer is currently the only company pursuing regulatory applications for an RSV investigational vaccine candidate for both an older adult indication, as well as a maternal indication to help protect infants through maternal immunization.Why is there no vaccine against RSV? ›
That's because the protein that the virus uses to infect human cells, called the F protein, is a wily target. It can rapidly change its structure, Schaffner said, making it difficult to develop a vaccine that can effectively target it.Is RSV vaccine safe? ›
A vaccine against respiratory syncytial virus (RSV) was effective at preventing RSV-associated illness among older adults and the children of vaccinated mothers, based on interim results from 2 phase 3 trials.How long does RSV vaccine last? ›
Each dose of SYNAGIS helps protect your child from severe RSV disease for about a month. SYNAGIS should be given to high-risk babies every 28-30 days during RSV season. Talk to your doctor about a dosing schedule appropriate for your area.Is SYNAGIS FDA-approved? ›
SYNAGIS is the first and only FDA-approved monoclonal antibody for the prevention of severe RSV disease.Is RSV and whooping cough the same? ›
Respiratory syncytial virus, or RSV, and pertussis, commonly called whooping cough, are not likely to cause serious health issues for otherwise healthy adults, but it's still very important for everyone to take precautions against both.Who is most at risk for RSV? ›
People at increased risk of severe or sometimes life-threatening RSV infections include: Infants, especially premature infants or babies who are 6 months or younger. Children who have heart disease that's present from birth (congenital heart disease) or chronic lung disease.
N) experimental respiratory syncytial virus (RSV) vaccine was 82% effective in preventing severe infections in infants when given to expecting mothers in the second half of their pregnancy, according to trial details published on Wednesday that confirm preliminary data from the study.
Is RSV a Covid? ›
What is the difference between the flu, COVID-19, and RSV? The flu, COVID-19, and respiratory syncytial virus (RSV) are all highly contagious respiratory infections caused by viruses: The flu by influenza virus, COVID-19 by SARS-CoV-2 virus, and RSV by respiratory syncytial virus.