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FDA Grants Approval for AREXVY, the First Respiratory Syncytial Virus (RSV) Vaccine

By: Urooj K. Malik, PharmD Candidate c/o 2024

On May 3, 2023, the United States (U.S.) Food and Drug Administration (FDA) approved Arexvy (RSVPreF3), the first vaccine to combat respiratory syncytial virus (RSV) for adults aged 60 and older.1

Overview of RSV

RSV is a common respiratory virus that typically causes mild, cold-like symptoms that can progress to serious lung infections, mainly in infants, older adults, and individuals with serious medical issues.2 Within most regions of the U.S., RSV season starts during fall and peaks in the winter. This virus is highly contagious and can spread from person to person by traveling through the air through coughing, sneezing, or direct contact. In older adults, RSV is a common cause of lower respiratory tract disease (LRTD), that affects the lungs leading to life-threatening pneumonia and bronchiolitis.1 Each year in the U.S., RSV has led to approximately 58,000-80,000 hospitalizations among children less than 5 years old and 60,000-160,000 hospitalizations among adults 65 years and older.3 Compared to other respiratory diseases, RSV is the most common cause of pneumonia and bronchiolitis for children below the age of 1.4 GlaxoSmithKline (GSK), a global pharmaceutical company, developed the RSVPreF3 vaccine as a means to prevent LRTD in the 60 years and older population.

Summary of the AReSVi-006 Trial

The AReSVi-006 trial is an ongoing placebo-controlled, phase 3 clinical study conducted in North America, Europe, Asia, Africa, and Australia. A total of 24,966 individuals partook in this trial with 12,467 participants receiving the RSVPreF3 vaccine and 12,499 receiving saline placebo. Participants were included in the trial if they did not report an RSV-confirmed acute respiratory illness before day 15. Participants with pre-existing chronic conditions that were stable including diabetes, hypertension, and cardiac disease were approved to participate in the trial if deemed medically stable by the investigator at the time of getting vaccinated. However, immunocompromised participants were excluded. Participants were followed up for the development of an RSV-associated LRTD for up to 10 months. Follow-up was conducted starting from day 15 post-vaccination.5 The participants will remain in this study through three RSV seasons to evaluate the duration of effectiveness and safety of repeat annual vaccination.

The primary endpoint of this study was the efficacy of the RSVPreF3 vaccine in the prevention of RSV-LRTD in adults at least 60 years of age during the first season.5 In this study, RSV-LRTD was defined as at least 2 LRTD signs and symptoms including at least 1 LRTD sign for at least 24 hours or at least 3 LRTD symptoms for at least 24 hours.5 Lower respiratory symptoms included new or increased sputum, new or increased cough, and/or new or increased dyspnea. Lower respiratory signs consisted of new or increased wheezing, crackles/rhonchi, a respiratory rate of at least 20 respirations/minute, low or decreased oxygen saturation, and need for oxygen supplementation.5

The secondary endpoint was efficacy against RSV-LRTD in participants with at least 1 comorbidity. Comorbidities of interest included chronic obstructive pulmonary disease (COPD), asthma, other chronic respiratory/pulmonary diseases, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease.5

Results from the first RSV seasons became recently available which led to the FDA’s approval of the vaccine. It was seen that 82.6% of participants achieved overall efficacy against RSV-LRTD with the vaccine and reduced the risk of developing severe RSV-associated LRTD by 94.1%. The most commonly reported (incidence of ≥10%) adverse reactions were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%). Serious adverse events of atrial fibrillation were reported in 10 participants who received the RSVPreF3 vaccine and 4 participants that received placebo. There was a 94.6% efficacy against RSV-LRTD in participants with at least 1 comorbidity.5 There is still ongoing surveillance and research being conducted to comprehensively understand the vaccine’s long-term effects and its impact on different age groups, specifically adults 75 years and older and those with an underlying medical condition.6

Pharmacists’ Role in Administrating RSV Vaccines Within New York State (NYS)

On August 8, 2023, the New York State Department of Health, in partnership with the State Education Department, issued a determination letter to make the RSV vaccine to soon be administered to adults ages 60 and older in pharmacies statewide.7 The vaccine will also be available to be administered by other trusted health care providers. New York Board of Regents Chancellor, Lester W. Young, Jr., shares in the excitement of this new vaccine and the role pharmacists will play in administering it by stating, “[t]his determination is a major victory for access and equity in health care. Research indicates RSV has a major impact on infants and older adults living in communities that often have limited access to health care resources. Pharmacists play a critical role in expanding access and increasing vaccination rates. I applaud Commissioner McDonald for this decision, which takes us one step further toward providing equitable and obtainable health care for all New Yorkers.”7

In addition, the RSV vaccine will be covered under Medicare Part D, meaning many adults will have greater accessibility to the vaccine in their pharmacies.6 As New Yorkers prepare for the upcoming fall season when RSV typically spreads, GSK recently announced that their vaccine is now available at major U.S. retail pharmacies.8 With this milestone, the nation moves one step closer to eradicating the threat of RSV and procuring a healthier future for generations to come. 


  1. FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine. U.S. Food and Drug Administration. Published May 4, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine.
  2. Respiratory Syncytial Virus (RSV). Centers for Disease Control and Prevention. Updated August 4, 2023. Accessed September 20, 2023. https://www.cdc.gov/rsv/
  3. RSV Research and Surveillance. Centers for Disease Control and Prevention. Published October 28, 2022. Accessed September 18, 2023. https://www.cdc.gov/rsv/research/
  4. Symptoms and Care for RSV. Centers for Disease Control and Prevention. Published September 6, 2023. Accessed September 18, 2023. https://www.cdc.gov/rsv/about/symptoms.html
  5. Papi A, Ison MG, Langley JM, et al. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023;388(7):595-608. doi:10.1056/NEJMoa2209604
  6. Constantino AK. CDC advisory panel backs use of GSK and Pfizer RSV vaccines in adults 60 and older. CNBC. Published June 21, 2023. https://www.cnbc.com/2023/06/21/rsv-vaccine-cdc-panel-pfizer-gsk-shots-adults-over-60.html
  7. New York State Department of Health, in Partnership with State Education Department, Takes Steps Necessary to Ensure RSV Vaccine for Adults Over Age 60 Will Be Administered in Pharmacies Statewide. New York State Department of Health.; 2023. Accessed August 19, 2023. https://www.health.ny.gov/press/releases/2023/2023-08-08_rsv
  8. GSK announces AREXVY, its respiratory syncytial virus (RSV) vaccine, is now available at all major US retail pharmacies. GSK US. Published August 17, 2023. Accessed August 19, 2023. https://us.gsk.com/en-us/media/press-releases/gsk-announces-arexvy-its-respiratory-syncytial-virus-rsv-vaccine-is-now-available-at-all-major-us-retail-pharmacies/
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