Vaccine Info


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Last reviewed
May 2, 2024

AREXVY™ RSV Vaccine Clinical Trials, Dosage, Indication, News, Side Effects

GlaxoSmithKline Biologicals (GSKAREXVY™ recombinant, AS01E adjuvanted, single dose, RSV vaccine contains a recombinant subunit pre-fusion respiratory syncytial virus (RSV) glycoprotein antigen (RSVPreF3) combined with GSK's proprietary ASO1 adjuvant. The antigen plus adjuvant combination helps overcome the natural decline in immunity that contributes to the challenge of protecting people from RSV disease. AREXVY contains Agenus' proprietary QS-21 STIMULON™ within its AS01 adjuvant, which has already demonstrated positive immune responses and a favorable safety profile. QS-21 Stimulon improves a vaccine's effectiveness by inducing strong antibody and cell-mediated immune responses. It also plays a crucial role in boosting immune response in older adults who often experience age-related decline in immunity.

GSK announced positive phase III trial results for its RSV vaccine, demonstrating an overall vaccine efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs. 40 of 12,494) against RSV lower respiratory tract disease (RSV-LRTD), meeting the AReSVi 006's primary endpoint. On February 16, 2023, the NEJM published an ORIGINAL ARTICLE: Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. Findings: A single dose of the RSVPreF3 OA vaccine had an acceptable safety profile in a phase 3 study and prevented RSV-related acute respiratory infection and lower respiratory tract disease and severe RSV-LRTD in adults 60 years of age or older, regardless of RSV subtype and the presence of the underlying coexisting condition. GSK funded the AReSVi-006 NCT04886596.

The European Medicines Agency (EMA) recommended marketing authorization in the European Union (EU) on April 26, 2023, for Arexvy for active immunization to protect adults aged 60 years and older against LRTD caused by RSV. The opinion of EMA's Committee for Human Medicines (CHMP) is based on data from a randomized, placebo-controlled trial in 25,000 adults in 17 countries. The European Commission authorized Arexvy on June 7, 2023, and the results showed an estimated 83% protection against RSV-confirmed LRTD for at least six months. On January 29, 2024, the EMA accepted the company's regulatory application to expand the use of Arexvy to adults aged 50-59 at increased risk for RSV disease. If accepted, GSK's RSV vaccine would be the first vaccine available to help protect this population.

On May 3, 2023, the U.S. Food and Drug Administration (FDA) approved Arexvy to prevent LRVD caused by RSV in individuals 60 and older in the U.S. (PRESCRIBING INFORMATION, Package Insert). The U.K.'s Medicines and Healthcare products Regulatory Agency authorized Arexvy on July 10, 2023, and then Canada on August 4, 2023.

GlaxoSmithKline plc (LSE/NYSE: GSK) is located in Brentford, West London, England, and is a science-led global healthcare company. For further information, please visit AREXVY trademark was issued on November 15, 2022.

AREXVY Vaccine Revenues

On May 1, 2024, GSK announced that Arexvy delivered Q1 2024 sales of £182 million, reflecting continued strong consumer uptake and leading market share. In the U.S., Q1 2024 sales were £154 million, with the overwhelming majority of doses administered in retail. Arexvy maintained around two-thirds of the vaccination share. Over seven million of the 83 million US adults aged 60 and older at risk have been protected by Arexvy since the launch in Q3 2023. The performance in Q1 2024 also reflected deliveries in Saudi Arabia, Canada, and Brazil. GlobalData plc issued an Arexvy seven-year sales forecast on July 24, 2023, predicting sales would reach $2.5 billion in 2029.

AREXVY Indication

According to the WHO, RSV represents a significant health threat for older adults. Arexvy has been approved for adults >60 years of age and older. On February 6, 2024, GSK announced that the US FDA had accepted an application under Priority Review to extend the indication of Arexvy to adults aged 50-59 at increased risk for RSV disease. On December 12, 2023, Japan's Ministry of Health, Labour, and Welfare accepted an application for Arexvy in adults aged 50-59 for review.

AREXVY Vaccine U.S. CDC Review

The U.S. CDC Advisory Committee on Immunization Practices (ACIP) conducted an RSV review on October 25, 2023. Camille Kotton, MD, presented an overview, Monica E. Patton, MD, presented the epidemiology of RSV hospitalizations in adults, and Amadea Britton, MD, MS, presented ACIP Adult RSV Work Group Considerations. On July 21, 2023, the CDC's Morbidity and Mortality Weekly Report confirmed the efficacy of 1 dose of the GSK vaccine in preventing symptomatic, laboratory-confirmed RSV-associated LRTD was 82.6% (96.95% CI = 57.9%–94.1%) during the first RSV season and 56.1% (95% CI = 28.2%–74.4%) during the second season. Efficacy of 1 dose over two seasons was 74.5% (97.5% CI = 60.0%–84.5%) in preventing RSV-associated LRTD and 77.5% (95% CI = 57.9%–89.0%) in preventing medically attended RSV-associated LRTD. Leonard Friedland, M.D. Vice President, Scientific Affairs and Public Health, GSK, resented updated data. The ACIP committee voted to recommend Arexvy for preventing RSV disease in adults aged 60 and older with shared clinical decision-making. The committee recommendations mean over 55 million older adults in the U.S. could have access to RSV vaccination for the first time. On February 23, 2023, presentations included Ismael R. Ortega-Sanchez, Ph.D., presented - Economics of Vaccinating U.S. Adults ≥60 years old against RSV; Evidence to Recommendations Framework. On October 20, 2022, Bishoy Rizkalla, GSK Global Medical Affairs, presented an update to the CDC's vaccine committee.


On February 6, 2024, the U.S. FDA set a Prescription Drug User Fee Act action date of June 7, 2024, regarding expanding Arexvy's indication. The FDA conducted a Vaccines and Related Biological Products Advisory Committee (VRBPAC) AREXVY review meeting for (STN 125775/0) on March 1, 2023. The FDA published the Briefing Document, GSK SPONSOR BRIEFING DOCUMENT, and Errata to the GSK Briefing Document. The committee voted unanimously (100%) that the data supported the effectiveness of the vaccine and 10-2 that the data supported the safety of the RSV vaccine. On November 2, 2022, GSK announced that the FDA had accepted a Biologics License Application (BLA) (STN 125775/0) and granted a Priority Review for the RSVPreF3 OA vaccine candidate.

AREXVY Availability 2024

As of 2024, Arexvy was available in major retail pharmacies in the U.S. The U.S. FDA approved Arexvy on May 3, 2023. Europe approved Arexvy on June 7, 2023, followed by Japan, the U.K. and Canada. GSK plc stated regulatory progress in Australia is pending.

AREXVY Coadministration Influenza Vaccines

Available data on the immunogenicity of coadministration of RSV vaccines and other vaccines are currently limited, says the U.S. CDC. Administering an RSV vaccine with other vaccines might increase local or systemic reactogenicity and RSV and influenza antibody titers were somewhat lower with coadministration; however, the clinical significance of this is unknown. GSK presented acceptable coadministration with influenza vaccine data to the U.S. FDA on March 1, 2023.


Prescribing information was posted on May 3, 2023. Recent in-house results from a parallel phase III trial, AReSVi 004, showed that, in participants aged 60 years and above, one dose of the RSV OA investigational vaccine induced strong humoral and cellular immune responses that remained above pre-vaccination levels up to at least the six-month post-vaccination readout timepoint.

AREXVY Safety Data

GSK presented data to the U.S. FDA on March 1, 2023, indicating limited safety data following vaccination in multiple studies. The EMA confirmed on April 26, 2023, the most common side effects reported were headache, tiredness, muscle pain, joint pain, and injection site pain.

AREXVY Maternal Vaccine Candidate

Arexvy is not approved for use in persons <60 years of age. In a clinical study that enrolled pregnant individuals who received an investigational unadjuvanted RSV vaccine that contained the same RSVPreF3 antigen as AREXVY, an increase in preterm births was observed compared to pregnant individuals who received placebo (sucrose reconstituted with saline. In the vaccine and placebo groups, 6.81% and 4.95% of preterm births were reported, respectively. The maternal RSV candidate vaccine was tested in three doses compared with a placebo in 502 healthy non-pregnant women over monthly visits (Day 8, Day 31, and Day 91 post-immunization). The data show that compared with the base, the investigational vaccine rapidly boosted the pre-existing immunity at all doses, leading to high levels of protective neutralizing antibodies. On Day 8, a 14-fold increase in RSV-A and RSV-B neutralizing antibody titers was observed. As of May 27, 2023, this product was on hold.


GSK plc announced on August 17, 2023, that Arexvy costs will be covered by most U.S. Medicare and commercial insurance plans under the Inflation Reduction Act, and patients with Medicare Part D will pay no out-of-pocket expenses. As part of the Affordable Care Act, AREXVY may be covered for commercially insured patients at no cost when administered in-network.

AREXVY Vaccine News

November 1, 2023 - Emma Walmsley, Chief Executive Officer, GSK: "GSK is delivering strong and sustained performance momentum, with another quarter of double-digit sales and earnings growth. Competitive performance was broadly based but benefitted particularly from the outstanding U.S. world's Arexvy, the world's first RSV vaccine."

JuneCDC's2023 - The U.S. CDC's ACIP voted 9 to 5 and recommended people 60 and older may receive an RSV vaccine dose using shared clinical decision-making.

April 26, 2023 - The EMA recommended a marketing authorization in the European Union for Arexvy.

June 10, 2022 - GSK plc announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial. The interim analysis indicates the primary endpoint was exceeded, with no unexpected safety concerns observed.

June 10, 2022 - Agenus shared that partner GSK announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial evaluating their investigational RSV vaccine in adults aged 60 years and above. The primary endpoint was exceeded, with no unexpected safety concerns observed.

February 16, 2021 - GSK announced the Phase 3 RSV candidate program for older adults. This phase 3 study is after the release of positive Phase I/II results on safety, reactogenicity, and immunogenicity.

November 23, 2020 - GlaxoSmithKline plc announced that patient dosing had begun in phase 3 clinical program investigating the safety and efficacy of its RSV candidate vaccine for maternal immunization (GSK3888550A) following the presentation of positive phase 1/2 safety, reactogenicity, and immunogenicity data last month

RSV OA Vaccine Clinical Trials

The GSK RSVPreF3 RSV vaccine has been involved in over ten clinical studies.

On October 25, 2023, GSK announced preliminary results from a phase III clinical trial showing that the primary endpoints had been met, with non-inferior immune responses observed in adults aged 50-59 compared to adults aged 60 and older. Adults aged 50 and above with certain underlying medical conditions are at increased risk for RSV disease. GSK is on track to being the first company to submit data in this population to regulators, with decisions on potential label expansion expected in 2024.

The AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial is a randomized, placebo-controlled, observer-blind, multi-country demonstrating the efficacyGSK's single dose of GSK's adjuvanted RSVPreF3 OA investigational vaccine in adults aged 60 years and above. Approximately 25,000 participants from 17 countries were enrolled. AReSVi 006 is a phase III trial. Last Update Posted: June 30, 2022.

Results: 24,966 participants received one dose of the RSVPreF3 OA vaccine (12,467 participants) or placebo (12,499). Over a median follow-up of 6.7 months, vaccine efficacy against RT-PCR–confirmed RSV-related lower respiratory tract disease was 82.6% (96.95% confidence interval [CI], 57.9 to 94.1), with 7 cases (1.0 per 1000 participant-years) in the vaccine group and 40 patients (5.8 per 1000 participant-years) in the placebo group. Vaccine efficacy was 94.1% (95% CI, 62.4 to 99.9) against severe RSV-related lower respiratory tract disease (assessed based on clinical signs or by the investigator) and 71.7% (95% CI, 56.2 to 82.3) against RSV-related acute respiratory infection. Vaccine efficacy was similar against the RSV A and B subtypes (for RSV-related lower respiratory tract disease: 84.6% and 80.9%, respectively; for RSV-related acute respiratory infection: 71.9% and 70.6%, respectively). In addition, high vaccine efficacy was observed in various age groups in participants with coexisting conditions. The RSVPreF3 OA vaccine was more reactogenic than the placebo, but most adverse events for which reports were solicited were transient, with mild-to-moderate severity. The incidences of serious adverse events and potential immune-mediated diseases were similar in the two groups.


Clinical Trials

No clinical trials found