Respiratory Syncytial Virus (RSV) Vaccines September 2023
Developing respiratory syncytial virus (RSV) vaccines has been identified as a priority by the World Health Organization (WHO) Initiative, which began in the 1960s. As of September 23, 2023, RSV vaccines have been approved in Europe, the United States, and the United Kingdom. Various pharmaceutical companies are conducting phase 3 clinical trials on RSV vaccine candidates. As of September 2023, the U.S. Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and the European Commission (EC) recommend adults 60 years and older and pregnant women receive a single dose of an RSV vaccine based on discussions with healthcare providers and under certain conditions.
The Bill & Melinda Gates Foundation and Gavi, the Vaccine Alliance, are working to improve access to RSV vaccines in low- and middle-income countries in 2023. A new poll from the University of Michigan's Institute for Healthcare Policy and Innovation revealed that 21% of seniors want an RSV vaccination in 2023.
RSV Vaccines Approved 2023
The U.S. CDC announced on June 29, 2023, July 21, 2023, and September 22, 2023, that using RSV vaccines for people ages 60 and older and pregnant women was approved under specific conditions.
AREXVY™ RSV vaccine is approved for adults aged 60 and above. AREXVY became available in U.S. pharmacies on August 17, 2023. Additional launches are planned in Europe, the United Kingdom, and Canada.
ABRYSVO™ RSVpreF RSV bivalent vaccine from Pfizer Inc. received U.S. FDA and European Commission Approval for older adults and pregnant women during RSV season.
RSV Vaccine Candidates
RSV vaccine clinical trials are active and seeking participants as of September 2023.
mRNA-1345 is a vaccine candidate against RSV developed by Moderna, Inc., encoding for a prefusion F glycoprotein, eliciting a superior neutralizing antibody response compared to the postfusion state. Based on the ConquerRSV Phase 3 pivotal efficacy trial, Moderna submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency, Swissmedic, and the Therapeutic Goods Administration in Australia. The Company has also initiated a rolling submission for a Biologics License Application for mRNA-1345 to the U.S. FDA. And mRNA-1345 is being investigated in a fully enrolled, ongoing Phase 1 trial in pediatric populations.
Codagenix Inc. CodaVax™-RSV is an intranasal, live-attenuated vaccine candidate for preventing RSV infection that received U.S. FDA-Fast Track designation and has launched two phase 1 studies. A pediatric Phase 1 study evaluating CodaVax has an age de-escalation, dose-escalation design specifically assessing safety and immunogenicity in the 6-month to 5-year-old population.
Meissa Vaccines MV-012-968 is an investigational, live attenuated vaccine protecting against RSV. Meissa's intranasal live attenuated MV-012-968 vaccine candidate induces systemic solid mucosal IgA antibody response in RSV-naïve children. As of August 8, 2023, 100% of RSV-naïve infants and toddlers responded to two doses of 107 PFU of MV-012-968. Safety data show that MV-012-968 is well-tolerated and highly attenuated, with no related serious adverse events, no Grade 2 or 3 fever reported, and low levels of transient vaccine virus shedding detected at the highest doses.
ResVax is a vaccine candidate from Novavax composed of recombinant RSV F nanoparticles adsorbed to aluminum phosphate. The F protein is essential to RSV infectivity and is the target of palivizumab.
DS-Cav1 was developed by VRC, NIAID, and is composed of the RSV fusion glycoprotein ectodomain assembled as a trimer stabilized in its prefusion native conformation with a foldon trimerization domain at the C-terminus and four internal mutations designated DS-Cav1 (4.1DHFR_RSVAF).
IVX-121, an RSV vaccine candidate, incorporates a stabilized prefusion F antigen licensed from NIAID/NIH (DS-CAV1). VLP technology further enhances the response's magnitude, quality, and durability to the prefusion RSV F. In this Phase 1 trial, IVX-A12 induced robust immune responses against RSV and hMPV at Day 28 in older adults across dosage levels and with and without adjuvant.
Ad26.RSV preF vaccine is a protein-based RSV vaccine candidate tested on adults produced by Pfizer, Inc.
EDP-938, Enanta's lead N-protein inhibitor, is being developed to treat RSV infection and was granted Fast Track Designation by the U.S. FDA.
BLB201 is a single-dose intranasal vaccine that induces serum antibody and mucosal antibody responses as well as cell-mediated immune responses for the prevention of RSV infection from Blue Lake Biotechnology, Inc. BLB-201 is based on an attenuated strain of canine parainfluenza virus and expresses the RSV-F protein and is conducting a phase 1 study of CPI-RSV-F Vaccine (BLB-201). On November 7, 2022, the first study cohort showed that 64% of subjects had increased serum anti-RSV antibody responses above baseline levels. Therefore, the FDA granted Fast Track status on May 24, 2022.
Icosavax Inc. IVX-A12 is a bivalent (RSV/hMPV) formulation, incorporating single and multiple hMPV dosage levels in older adults 60 and above. The FDA granted Fast Track designation for IVX-A12 on February 21, 2023.
Artificial Cell Technologies, Inc. developed a fully synthetic microparticle RSV vaccine candidate.
Calder Biosciences will evaluate DT-preF, its lead RSV vaccine candidate, as part of a Phase I clinical trial that will include an efficacy read-out. Preclinical studies are designed to assess the toxicity and tolerability of the lead candidate vaccine. The preclinical study will begin in November 2023, and the Phase 1 clinical study will start in H1 2024.
RSV/6120/ΔNS2/1030s is a live-attenuated intranasal RSV vaccine candidate containing a deletion of the interferon antagonist NS2 gene, and a genetically stabilized temperature-sensitivity mutation in the polymerase gene was infectious and induced primary neutralizing serum antibody responses and potent memory antibody responses in 6-to-24 month-old RSV-seronegative children but may be associated with rhinorrhea.
RSV Vaccine in China
Pfizer Inc. and LianBio announced on December 19, 2022, that Pfizer opted into the right to develop and commercialize sisunatovir (RV521), RSV therapeutic candidates in Mainland China, Hong Kong, Macau, and Singapore. Sisunatovir is being evaluated for potentially treating RSV infection in pediatric and adult patients. The U.S. FDA granted Sisunatovir Fast Track Designation in 2020. In addition, it is being considered in a global phase 2 clinical study in children. On November 14, 2022, Nuance Pharma announced China's Center for Drug Evaluation approved its application supporting its pivotal phase IIMVA-BN RSV vaccine clinical trial.
RSV Monoclonal Antibody 2023
Monoclonal antibody therapies for children are U.S. FDA-approved as of August 2023.
U.S. CDC RSV Vaccine Reviews
On September 22, 2023, the U.S. CDC's Advisory Committee on Immunization Practices (ACIP) conducted an RSV review and voting session. On June 21, 2023, Camille Kotton, MD, presented an Adult RSV vaccine review session during the ACIP meeting. Alejandra Gurtman, MD, FIDSA, Pfizer, presented data, as did Leonard Friedland, MD, Vice President, Scientific Affairs and Public Health, GSK, who presented RSV vaccine updates. Michael Melgar, MD, led the Evidence to Recommendations Framework and Clinical Considerations for RSV Vaccines presentations. The RSV Economic Analysis review was directed by David W. Hutton, Ph.D., MS., and Ismael R. Ortega-Sanchez, Ph.D. NCIRD/CDC led the SUMMARY COMPARING MODELS (cost-effectiveness) from GSK, Pfizer, and the University of Michigan-CDC. The ACIP voted 9 to 5, recommending people 60 and older receive an RSV vaccine using shared clinical decision-making in 2023. On June 22, 2023, the U.S. CMS confirmed these RSV vaccines would be included in Medicare Part D plans.
Note: On August 2, 2023, patent litigation was filed against Pfizer by GSK plc.
RSV Coadministration With Influenza Vaccine
The U.S. CDC presented the following coadministration information on September 19, 2023 - There is currently limited data on the immunogenicity of coadministration of RSV and other vaccines. In general, the coadministration of RSV and seasonal influenza vaccines met noninferiority criteria for immunogenicity. However, RSV and influenza antibody titers were generally somewhat lower with coadministration; the clinical significance of this is unknown. Additional studies on the immunogenicity of coadministration of RSV with other adult vaccines are in process. A draft, revised vaccine schedule addendum was presented on September 22, 2023.
RSV Seasonality 2023
The U.S. CDC, ECDC, and WHO report RSV has seasonality trends.
RSV Vaccine Price
The global RSV Therapeutics Market Size is estimated to reach about $836 million by 2028, exhibiting a CAGR of 5.76%. Additional RSV vaccine and treatment price information are posted at InstantRx™.
