RSVPreF3 OA Vaccine Description for 2022
GSK's RSV OA (Older Adult) vaccine candidate contains a recombinant subunit pre-fusion RSV glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01 adjuvant. The antigen plus adjuvant combination may help overcome the natural age-related decline in immunity that contributes to the challenge of protecting older adults from RSV disease.
On November 2, 2022, GSK announced that the U.S. Food and Drug Administration (FDA) had accepted a Biologics License Application (BLA) and granted a Priority Review for their RSVPreF3 OA vaccine candidate. The FDA action date for their regulatory decision is 3 May 2023.
GSK's RSVPreF3 OA vaccine candidate 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 key 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 respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above to be presented at IDWeek 2022. The vaccine candidate was highly efficacious, demonstrating 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.
Dr. Hal Barron, Chief Scientific Officer and President of R&D, GSK, said in a press release on June 10, 2022, "These data suggest our RSV vaccine candidate offers exceptional protection for older adults from the serious consequences of RSV infection. RSV remains one of the few major infectious diseases without a vaccine, and these data have the potential to meaningfully impact the treatment of RSV and may reduce the 360,000 hospitalizations and more than 24,000 deaths worldwide each year. Given the importance of these data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022."
On October 20, 2022, Bishoy Rizkalla, GSK Global Medical Affairs, presented an update to the U.S. CDC's vaccine committee.
GlaxoSmithKline plc (LSE/NYSE: GSK) is a science-led global healthcare company. For further information, please visit www.gsk.com/about-us.
RSVPreF3 OA Vaccine Availability
GSK plc stated announcements on regulatory progress in Japan, the U.S., and E.U. are expected in 2022.
RSVPreF3 OA Vaccine Indication
According to the WHO, RSV represents a significant health threat for older adults (>65 years of age), with 360,000 hospitalizations and 24,000 deaths associated with RSV infections estimated annually in developed countries. The risk of severe disease in adults is increased by the presence of underlying chronic pulmonary disease, circulatory conditions, and functional disability and is associated with higher viral loads.
RSVPreF3 OA Vaccine Dosage
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, which remain above pre-vaccination levels up to at least the six months post-vaccination readout timepoint.
RSVPreF3 Maternal Vaccine Candidate
GSK is working on an RSV vaccine for pregnant mothers.
The maternal RSV candidate vaccine was tested with 3 different 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 baseline:
- the investigational vaccine was able to rapidly boost the pre-existing immunity at all dose levels, leading to high levels of protective neutralizing antibodies
- On Day 8, a 14-fold increase in RSV-A and RSV-B neutralizing antibody titers were observed.
RSVPreF3 OA Vaccine News 2021- 2022
November 2, 2022 - The U.S. FDA has set a Prescription Drug User Fee Act action date of May 3, 2023. If approved, GSK’s RSV older adult vaccine candidate has the potential to be the first vaccine available to help protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
October 21, 2022 - GSK plc announced that a new drug application for its RSV older adult vaccine candidate (RSVPreF3 OA) had been accepted for review by the Japanese Ministry of Health, Labour, and Welfare.
October 13, 2022 - GSK's older adult respiratory syncytial virus (RSV) vaccine candidate shows a 94.1% reduction in severe RSV disease and overall vaccine efficacy of 82.6% in the pivotal trial.
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 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 has begun in a phase 3 clinical program investigating the safety and efficacy of its Respiratory Syncytial Virus (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 10 clinical studies.
The AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial is a randomized, placebo-controlled, observer-blind, multi-country trial to demonstrate the efficacy of a single dose of GSK's adjuvanted RSVPreF3 OA investigational vaccine in adults aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries. AReSVi 006 is a phase III trial.