Respiratory Syncytial Virus (RSV) Vaccines March 2023
Developing respiratory syncytial virus (RSV) vaccines has been identified as a priority for the World Health Organization (WHO) Initiative for Vaccine Research. RSV vaccine development began in the 1960s. Various pharmaceutical companies are currently conducting late-stage human clinical trials.
As of March 27, 2023, neither the U.S. Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) had approved an RSV vaccine. The FDA has scheduled Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings for February 28 and March 1, 2023. The U.S. Centers for Disease Control and Prevention (CDC) conducted an RSV vaccine review on February 23, 2023.
And the Bill & Melinda Gates Foundation and Gavi, the Vaccine Alliance, are working to improve access to RSV vaccines and monoclonal antibodies in low- and middle-income countries in 2023.
RSV Vaccine Candidates
ABRYSVO™ RSVpreF (PF-06928316) RSV vaccine candidate (BLA 125769) from Pfizer Inc. received U.S. FDA Breakthrough Therapy Designation(s) for infants, seniors, and pregnant women, and it accepted BLA(s) for priority review. The FDA's Prescription Drug User Fee Act goal date for a decision on ABRYSVO application(s) begins in May 2023. In addition, the European Medicines Agency (EMA) has also started the regulatory approval process.
AREXVY™ RSV OA (GSK3888550A) GSK's investigational single-dose RSV vaccine candidate (BLA 125775) is currently conducting a phase 3 study in adults aged 60 and above. The FDA voted in favor of the approval of this vaccine on March 1, 2023. has set a Prescription Drug User Fee Act action date of May 3, 2023.
mRNA-1345 is a vaccine 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 intends to submit for regulatory approval in the first half of 2023.
Janssen RSV Vaccine candidate efficacy and immunogenicity data from the Phase 2b CYPRESS stud,y demonstrated 80% vaccine efficacy in adults aged 65 and older. In addition, a Phase 3 Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based RSV Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older.
Codagenix Inc. CodaVax™-RSV is an intranasal, live-attenuated vaccine candidate for preventing RSV infection in healthy infants and toddlers receiving U.S. FDA-granted Fast Track designation.
MVA-BN® RSV, the Bavarian Nordic vaccine candidate, incorporates five different RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B). The Phase 3 clinical trial includes adults ≥60 years of age. The data analysis is progressing according to plan, and the topline results from the study are still anticipated in mid-2023. MVA-BN RSV has been granted Breakthrough Therapy Designation by the FDA and granted access by the EMA to its PRIME scheme.
Meissa Vaccines MV-012-968 is an investigational, live attenuated vaccine protecting against RSV. Meissa's intranasal live attenuated MV-012-968 vaccine candidate induced strong systemic and mucosal IgA antibody response in RSV-naïve children.
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 magnitude, quality, and durability of the response to the prefusion RSV F., The enhanced response to VLP-based prefusion F could be particularly important in older adult populations
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 a single RSV dosage level and multiple hMPV dosage levels n older adults 60 years of age 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. Layer-by-layer microparticle fabrication was used to produce synthetic vaccines presenting a fusion peptide containing RSV G protein CX3C chemokine motif and a CD8 epitope of the RSV matrix protein 2 with or without a covalently linked TLR2 agonist (Pam3.GM2).
RSV Vaccine in China
Pfizer Inc. and LianBio announced on December 19, 2022, that Pfizer opted-in to the right to develop and commercialize sisunatovir (RV521), RSV therapeutic candidate 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 evaluated in a global phase 2 clinical study in children.
On November 14, 2022, Nuance Pharma announcedChina'ss Center for Drug Evaluation approved its IND 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 in March 2023.
RSV Adults
The U.S. FDA VRBPAC reviewed on February 28, 20233, RSV Epidemiology and Disease Burden in Older Adults, presented by Fiona Havers, MD, MHS, FIDSA. On February 23, 2023, the U.S. CDC Advisory Committee on Immunization Practices (ACIP) conducted a digital and real-world meeting focused on RSV vaccines. Previously, in October 2022, ACIP presented RSV Vaccines for Older Adults led by Camille Kotton, MD.
In adults aged 50 years, hospitalization rates for RSV were similar to those associated with influenza as of 2018.
RSV Children
The U.S. CDC RSV Work Group presented on June 23, 2022 - RSV virion and vaccine products by Natalie Thornburg; Epidemiology of RSV in children by Dr. M McMorrow; In addition, on January 12, 2022, Sarah S. Long, MD, Chair, Maternal/Pediatric RSV Work Group, presented Introduction to ACIP's Maternal/Pediatric RSV Work Group during the U.S. CDC meeting. And the ACIP reviewed in February 2023 Maternal/Pediatric presentations led by Sarah S. Long, MD Chair, Maternal/Pediatric RSV Work Group: Nirsevimab for preventing RSV in infants; Jefferson Jones, MD MPH FAAP, Next Steps for the ACIP Maternal & Pediatric RSV Work Group.
RSV Trends 2023
The U.S. CDC Natalie J. Thornburg, Ph.D,. presented on February 28, 2023, RSV virology, strain variation, and surveillance measures. The rates presented on the RSV-NET interactive dashboard can be used to follow trends and comparisons of RSV-associated hospitalizations in different demographic groups and across seasons.
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™.
RSV Vaccine News 2023
March 1, 2023 - Phil Dormitzer, Global Head of Vaccines R&D, GSK, said in a press release, "Today's (positive) vote brings a significant step closer to delivering one of the world's first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a substantial burden on healthcare systems.
February 22, 2023 - The NEJM reported multiple RSV lineages were identified as contributing to the surge in 2022.
January 30, 2023 - Moderna, Inc. announced that the FDA granted mRNA-1345 Breakthrough Therapy Designation for preventing RSV-associated lower respiratory tract disease in adults 60 years or older.
January 5, 2023 - AstraZeneca stated in a press release if FDA approved, nirsevimab would be the first single-dose RSV preventative option for the broad newborn and infant population in the U.S.
December 22, 2022 - Bavarian Nordic A/S announced it completed the enrollment of subjects in the Phase 3 clinical trial of its MVA-BN® RSV RS vaccine candidate in older adults.
December 21, 2022 - Poolbeg Pharma announced it had successfully identified potential new drug candidates from its RSV artificial intelligence Programme. The Company has prioritized compounds with existing Phase I clinical data, which could be repositioned as novel treatments for RSV infection if successfully validated.
December 7, 2022 - U.S. FDA accepted for Priority Review the Biologics License Application for Pfizer's RSV vaccine candidate for Older Adults.
November 7, 2022 -"These initial phase 1 study results show that our PIV5 platform has an excellent safety profile so far and can stimulate pathogen-specific immune responses in humans," said Dr. Biao He, founded,r and CEO of Blue Lake Biotechnology.
November 7, 2022 - Meissa Vaccines announced interim clinical data of MV-012-968, an intranasal live attenuated RSV vaccine candidate, from a Phase 1c study in RSV-naïve young children.
November 4, 2022 - Iskra Reic, EVP, Vaccines and Immune Therapies, AstraZeneca, stated: "Beyfortus is the first single-dose preventative option against RSV to gain approval in Europe and is the first preventative option for a broad infant population."
November 2, 2022 - Codagenix Inc. announced that the U.S. FDA had granted Fast Track designation to CodaVax™-RSV.
November 2, 2022 - GSK plc announced that the U.S. FDA accepted a Biologics License Application and granted Priority Review for its RSV vaccine candidate for older adults.
November 1, 2022 - Pfizer Inc. announced positive topline data from the Phase 3 clinical trial MATISSE investigating its bivalent RSV prefusion vaccine candidate, RSVp, when administered to pregnant participants to help protect their infants from RSV disease after birth.
October 21, 2022 - The Japanese Ministry of Health, Labour, and Welfare accepted GSK's RSV vaccine candidate for review.
October 20, 2022 - The U.S. CDC staff presented RSV vaccine candidate updates for Older Adults, Maternal, and Pediatric.
October 13, 2022 - GSK plc announced positive pivotal phase III trial results for its RSV vaccine candidate for adults aged 60 years and above. 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 trial's primary endpoint.
October 10, 2022 - The Washington Post reported - For decades, fear and failure in the hunt for an RSV vaccine.
October 7, 2022 - Results from Ark Biopharmaceutical Co., Ltd.'ss Phase 3 study (AIRFLO), Ziresovir, a novel small-molecule RSV fusion (F) protein inhibitor,r, met both the primary endpoint of reduction in signs-and-symptoms score on day 3 of treatment and the key secondary endpoint of reduction in RSV viral load on day 5, compared with placebo.
September 28, 2022 - The Bill & Melinda Gates Foundation announced grants totaling nearly US$128 million to support the development and accessibility of maternal vaccines for Group B Streptococcus and RSV. In addition, a $27.5 million grant to Pfizer will support the development of an affordable multidose vial for delivery of the RSV vaccine candidate in lower-income countries via public sector purchasers, including Gavi.
September 16, 2022 - The European MedicinesAgency'ss Committee for Medicinal Products for Human Use adopted a positive opinion for Beyfortus® (nirsevimab)t to prevent RSV lower respiratory tract disease in newborns and infants during their first RSV season.
September 2, 2022 - The Lancet published an analysis - Quantifying the RSV immunity debt following COVID-19: a public health matter.
August 25, 2022 - Pfizer Inc. announced positive topline data from the Phase 3 clinical trial (RENOIR). Pfizer'ss RSVpreF efficacy of 85.7% was observed in participants with more severe disease primary endpoint of lower respiratory tract illness defined by analysis of three or more RSV-associated symptoms.
August 15, 2022 - The Journal of Infectious Diseases published: Impact of RSV on Child, Caregiver, and Family Quality of Life in the USA: Systematic Literature Review and Analysis.
August 12, 2022 - Sanofi and the National Institute for Health and Care Research announced that the first patient had been enrolled in the Hospitalised RSV Monoclonal Antibody Prevention study. Over 20,000 infants across three countries (the U.K., France, and Germany) will be enrolled from August 2022 to March 2023.
August 8, 2022 - The Lancet published - the RSV prevention landscape - If all the ongoing phase 3 trials generate positive results, relative efficacy and safety trial data, delivery strategies, and costs might determine vaccine uptake for different maternal and older adult candidates. Despite the approval of next-generation antibodies, palivizumab might remain on the market until global market access to extended half-life mAbs because mAb supply might not meet global demand.
July 21, 2022 - Science.org published: A.I. churns out possible medicines and vaccines. New A.I. software can"pain" structures for proteins that don't yet exist in nature.
July 21, 2022 - Blue Lake Biotechnology, Inc. announced the enrollment of the first participant in the Phase 1 clinical trial of their intranasal BLB-201 vaccine for RSV in Charleston, South Carolina.
July 7, 2022 - The UKHSA reported RSV positivity remained stable at 4.4% overall and decreased slightly to 13.0% in under 5-year-olds in week #26.
June 28, 2022 - Icosavax, Inc. announced positive topline interim results from its Phase 1/1b clinical trial of IVX-121, a VLP displaying a prefusion stabilized RSV F antigen, in young and older adults.
June 23, 2022 - The NEJM published an ORIGINAL ARTICLE: Vaccine Efficacy in Adults in a Respiratory Syncytial Virus Challenge Study. The RSVpreF vaccine was effective against symptomatic RSV infection and viral shedding in a phase 2 study. In addition, no evident safety concerns were identified.
June 10, 2022 - GSK plc announced its RSV OA vaccine candidate showed statistically significant and clinically meaningful efficacy in adults aged 60 years and above in a phase 3 study. The magnitude of the effect observed was consistent across RSV A and B strains, key secondary endpoints, and those aged 70 years and above.
June 8, 2022 - Associate Professor of Biomolecular Engineering at the Baskin School of Engineering Rebecca DuBois has been awarded the prestigious and highly competitive National Institutes of Health Research Project Grant of $3.8 million.
June 1, 2022 - Codagenix Inc. announced that the U.S. FDA approved the Investigational New Drug application for CodaVaxTM-RSV.
May 24, 2022 - Blue Lake Biotechnology, Inc. announced that the U.S. FDA was granted Fast Track designation for BLB-201, an intranasal vaccine for preventing RSV-associated disease in adults over 60 and children under two years of age.
May 19, 2022 - The Lancet published a systematic analysis of global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than five years in 2019.
May 16, 2022 - The U.S. FDA authorized the LabCorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription that can identify and differentiate multiple respiratory viruses simultaneously, detecting influenza A and B, respiratory syncytial virus, commonly known as RSV, along with SARS-CoV-2.
May 11, 2022 - AstraZeneca announced findings contributing to the growing evidence that nirsevimab can potentially protect all infants entering their first RSV season with a single dose.
May 2, 2022 - The WHO Influenza Update N° 418 confirmed RSV activity remained low in the U.S., Brazil, and Canada compared with pre-COVID-19 pandemic seasons.
April 28, 2022 - The NEJM published an Original Article (Phase 2b study): Prefusion F Protein-Based Respiratory Syncytial Virus Immunization in Pregnancy. CONCLUSIONS: RSVpreF vaccine-elicited neutralizing antibody responses with efficient transplacental transfer and without evident safety concerns.
April 20, 2022 - Bavarian Nordic A/S announced the dosing of the first subject in the Phase 3 VANIR clinical trial of its MVA-BN® RSV vaccine candidate in older adults.
April 4, 2022 - The WHO published Influenza Update N° 416 - RSV activity decreased in North America in the U.S. and Canada. And in Europe, overall, very little RSV activity was observed.
April 3, 2022 - The Israeli Health Ministry has authorized the expanded vaccination of premature babies against RSV with Palivizumab (Synagis).
March 28, 2022 - CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., announced that the U.S. FDA had cleared the investigational new drug application for BLB-201, an intranasal vaccine for the prevention of RSV infection.
March 25, 2022 - The Lancet published a correspondence: SARS-CoV-2 co-infection with influenza viruses, respiratory syncytial virus, or adenoviruses. Viral co-infection was detected in 583 (8·4%) patients: 227 had influenza viruses, 220 had the respiratory syncytial virus, and 136 had adenoviruses.
March 22, 2022 - Modernatx Inc. is launching a respiratory combination vaccine program to target three of the most significant viruses causing respiratory disease in older adults. The new combination respiratory vaccine candidate (mRNA-1230) is envisioned as an annual booster targeting the SARS-CoV-2 virus, influenza, and RSV.
March 21, 2022 - The WHO's Influenza Update N° 415 stated,'' In North America, respiratory syncytial virus activity further decreased in the U.S. and Canada.
March 21, 2022 - Bavarian Nordic A/S announced a development and commercialization agreement with Nuance Pharma of MVA-BN® RSV in China, Hong Kong, Macau, Taiwan, South Korea, and certain Southeast Asian countries.
March 14, 2022 - The journal PNAS published research on preventing antimicrobial prescribing among infants following maternal vaccination against the respiratory syncytial virus (RSV). In a double-blind, randomized, placebo-controlled trial, administering an RSV vaccine candidate to pregnant mothers reduced antimicrobial prescribing among their infants by 12.9% over the first three months of life.
March 10, 2022 - The Journal of Virology published - Structure-Based Design and Antigenic Validation of Respiratory Syncytial Virus G Immunogens. These studies show for the first time that an engineered RSV G protein with increased immunogenicity and safety retains conformational epitopes to high-affinity protective antibodies, supporting its further development as an RSV vaccine immunogen.
March 3, 2022 - An Original Article - The Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants - published by The NEJM, concluded a single injection of nirsevimab administered before the RSV season protected healthy late-preterm and term infants from medically attended RSV-associated lower respiratory tract infection.MedImmune/AstraZeneca and Sanofi funded the phase 3 study.
February 28, 2022 - The JAMA Network published an Original Investigation: Mortality Associated With Influenza and Respiratory Syncytial Virus in the U.S., 1999-2018. This study suggests that RSV poses a greater risk than influenza to infants, while both are associated with substantial mortality among elderly individuals.
February 17, 2022 - The EMA confirmed it accepted the Marketing Authorization Application for nirsevimab under an accelerated assessment procedure.
February 17, 2022 - The peer-reviewed journal NEJM published Original Research: EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge study. All EDP-938 regimens were superior to placebo concerning lowering the viral load, total symptom scores, and mucus weight without apparent safety concerns.
February 16, 2022 - The peer-reviewed journal Infectious Disease published an Accepted Manuscript: Morbidity of Respiratory Syncytial Virus-infections: RSV compared with SARS-CoV-2 infections in children aged 0 – 4 years in Cologne, Germany. Findings: RSV infections required greater hospital resource utilization than SARS-CoV-2 infections.
February 14, 2022 - Copenhagen-based Bavarian Nordic A/S announced its RSV vaccine candidate the U.S. FDA granted MVA-BN RSV Breakthrough Therapy DesignationA for active immunization to prevent lower respiratory tract disease caused by RSV in adults aged 60 years or older.
