Respiratory Syncytial Virus (RSV) Vaccines For 2022
The development of respiratory syncytial virus (RSV) vaccines has been identified as a priority for the World Health Organization (WHO) Initiative for Vaccine Research. And various pharmaceutical companies are conducting late-stage clinical trials.
RSV vaccine development began in the 1960s with an unsuccessful formalin-inactivated RSV (FI-RSV) vaccine, says the WHO. This RSV Vaccine and mAb Snapshot was updated in 2021.
However, as of May 17, 2022, the U.S. FDA has not Approved any RSV vaccine; however, there is an FDA authorized passive antibody treatment.
RSV Vaccine Candidates For 2022
mRNA-1345 is a vaccine against RSV developed by Moderna, Inc., encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state.
GSK's RSVPreF3 OA investigational single-dose RSV vaccine candidate is currently conducting a phase 3 study in adults aged 60 and above. It contains a recombinant subunit pre-fusion RSV antigen (RSVPreF3) combined with GSK's proprietary AS01 adjuvant.
Janssen RSV Vaccine candidate efficacy and immunogenicity data from the Phase 2b CYPRESS study 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.
MVA-BN RSV, Bavarian Nordic's vaccine candidate, incorporates five different RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B), thus mimicking the immune response observed following a natural reaction to an RSV infection.
Meissa Vaccines MV-012-968 is an investigational, live attenuated vaccine protecting against respiratory syncytial virus infection.
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
RSVpreF vaccine candidate from Pfizer Inc. is currently in phase 3 clinical study and recently received Breakthrough Therapy Designation(s) from the U.S. FDA for infants and seniors.
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.
BLB-201 is an intranasal vaccine for the prevention of RSV infection from Blue Lake Biotechnology, Inc. BLB-201 is based on an attenuated strain of PIV5 (also known as canine parainfluenza virus) and expresses the RSV-F protein and is conducting a phase 1 study of CPI-RSV-F Vaccine (BLB-201) in Healthy Young and Older Adults.
RSV Antibody Treatments For 2022
The U.S. FDA (1998), Canada, Japan, Israel, and the UK have approved Palivizumab (Synagis) (intramuscular injection) to protect at-risk patients (premature babies, infants) against RSV. The recommended dose of palivizumab (SYNAGIS) is 15mg/kg of body weight once a month has been shown to decrease hospitalizations.
Nirsevimab is an investigational long-acting antibody designed by Sanofi and AstraZeneca to protect infants against medically attended lower respiratory tract infections. Nirsevimab has been granted regulatory designations to facilitate expedited development by several regulatory agencies, including The China Center for Drug Evaluation under the National Medical Products Administration; U.S. FDA; European Medicines Agency; the UK Medicines and Healthcare products Regulatory Agency; and the Japan Agency for Medical Research and Development.
RSV Antiviral Therapeutics For 2022
Pfizer Inc. and ReViral Ltd. entered into a definitive acquisition agreement on April 7, 2022, focused on discovering, developing, and commercializing novel antiviral therapeutics that target the respiratory syncytial virus.
Ark Biopharmaceutical announced the successful results of the multicenter Phase 3 AirFLO study with ziresovir, a novel, oral, small-molecule RSV fusion protein inhibitor, in infants hospitalized with RSV. Ziresovir demonstrated a rapid onset of clinical effects, showing a 30% additional S&S score reduction compared with placebo (p=0.002) after two days of treatment.
RSV Vaccine News For 2020 - 2022
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 at the same time, detecting influenza A and B, respiratory syncytial virus, commonly known as RSV, along with SARS-CoV-2.
May 11, 2022 - AstraZeneca announced findings contribute to the growing body of evidence that nirsevimab has the potential to 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 - In North America, RSV activity further decreased 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 patients had influenza viruses, 220 patients had the respiratory syncytial virus, and 136 patients 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, 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 the prevention of 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. The phase 3 study was funded by MedImmune/AstraZeneca and Sanofi.
March 2, 2022 - Pfizer Inc. announced that its RSV vaccine candidate RSVpreF received Breakthrough Therapy Designation from the U.S. FDA to prevent RSV-associated lower respiratory tract illness in infants from birth up to six months age by active immunization of pregnant women.
February 28, 2022 - The JAMA Network published an Original Investigation: Mortality Associated With Influenza and Respiratory Syncytial Virus in the US, 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 28, 2022 - London-based GSK announced that further to the voluntary pause shared on February 18, the Company has decided to stop enrolment and vaccination in trials evaluating its potential RSV maternal vaccine candidate in pregnant women (NCT04605159, NCT04980391, NCT05229068).
February 27, 2022 - The NEJM published an Original Article: Azithromycin to Prevent Recurrent Wheeze Following Severe Respiratory Syncytial Virus Bronchiolitis. CONCLUSIONS: Azithromycin therapy for 14 days during acute severe RSV bronchiolitis did not reduce recurrent wheezing over the following 2 to 4 years.
February 23, 2022 - A research article: Early initiation of the respiratory syncytial virus season in 2021-2022, Greece - 'Awareness is needed to diagnose even the out-of-season RSV infections, while molecular epidemiology plays a key role in monitoring the efficacy of currently available therapeutics and for those under development.'
February 22, 2022 - Moderna, Inc. announced that the Data and Safety Monitoring Board for the RSV program had endorsed the start of the Phase 3 portion of the pivotal ConquerRSV clinical study of mRNA-1345 in adults 60 years and older.
February 18, 2022 - GlaxoSmithKline plc announced that it has voluntarily paused enrollment and vaccination in the GRACE phase III trial, evaluating its potential RSV maternal vaccine candidate and two other trials investigating this candidate in pregnant women (NCT04980391, NCT05229068).
February 17, 2022 - The European Medicines Agency 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 MVA-BN RSV was granted Breakthrough Therapy Designation by the U.S. FDA for active immunization to prevent lower respiratory tract disease caused by RSV in adults aged 60 years or older.
January 27, 2022 - The National Foundation for Infectious Diseases issued a Call to Action today urging stronger public health focus and increased awareness of RSV in the U.S. The report, Call to Action: Reducing the Burden of RSV across the Lifespan, addresses the underappreciated impact of RSV and outlines key strategic priorities to drive progress in RSV surveillance, diagnosis, prevention, and treatment.
December 29, 2021 - The JAMA Network published: RSV Vaccines, Finally Within Reach, Could Prevent Tens of Thousands of Yearly Deaths.
December 16, 2021 - The JAMA Network published an Orginal Investigation - This simulation modeling study found that virus introduction from external sources was associated with the spring and summer epidemics in 2021. These findings suggest that pediatric departments should be alert to large RSV outbreaks in the coming seasons, the intensity of which could depend on the size of the spring and summer epidemic in that location.
December 7, 2021 - The Janssen Pharmaceutical Inc. announced additional vaccine efficacy and safety data from its Phase 2b CYPRESS study of its respiratory syncytial virus adult vaccine candidate. Results show that the vaccine candidate was highly effective in protecting against three clinical definitions of lower respiratory tract disease caused by RSV, demonstrating vaccine efficacy of 70 to 80% in adults aged 65 and older.
December 6, 2021 - Bavarian Nordic A/S announced its commitment to initiate a Phase 3 clinical trial of its RSV vaccine candidate, MVA-BN® RSV.
December 3, 2021 - MedpageToday published Year in Review: Respiratory Syncytial Virus.
November 18, 2021 - Moderna, Inc. announced the first participant had been dosed in the ConquerRSV Phase 2/3 study of mRNA-1345, an RSV vaccine candidate.
October 20, 2021 - Science Translational Medicine published: Fatal enhanced respiratory syncytial virus disease in toddlers. This article characterizes the clinical, immunopathological, and transcriptional signature of fatal human ERD, outlining the evidence for safety evaluation of RSV vaccines and a framework for understanding disease enhancement for pathogens in general.
October 2, 2021 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its investigational RSV vaccine candidate was highly effective in protecting against lower respiratory tract disease caused by RSV, demonstrating a vaccine efficacy of 80% (CI, 52.2-92.9%) in adults aged 65 and older.
September 29, 2021 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the initiation of its Phase 3 EVERGREEN study that will evaluate the efficacy, safety, and immunogenicity of Janssen's investigational adult vaccine against lower respiratory tract disease caused by a respiratory syncytial virus, when compared with placebo in approximately 23,000 adults aged 60 years and older throughout North America and a selection of countries across Europe, Asia and the Southern Hemisphere. In September 2019, the U.S. FDA granted Breakthrough Therapy Designation for Janssen's investigational RSV adult vaccine to prevent LRTD caused by RSV in adults aged 60 years or older.
September 16, 2021 - the U.K.'s Public Health England published: Respiratory syncytial virus (RSV) is an enveloped RNA virus, in the same family as the human parainfluenza viruses and mumps and measles viruses. RSV is one of the common viruses that cause coughs and colds in winter.
September 9, 2021 - Seattle-based Icosavax, Inc. announced the initiation of a Phase 1/1b clinical trial of IVX-121, a VLP displaying a Respiratory Syncytial Virus stabilized pre-fusion F antigen in healthy adults and older adults.
September 9, 2021 - Public Health England reported Respiratory syncytial virus positivity decreased slightly to 12.6% in week #35, with the highest positivity in the under 5-year olds.
September 2, 2021 - Pfizer Inc. announced the initiation of RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease), a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus bivalent prefusion F subunit investigational vaccine candidate (RSVpreF) in adults ages 60 years or older.
September 1, 2021 - Bavarian Nordic A/S announced results from a human challenge phase 2 double-blinded, placebo-controlled trial enrolled healthy adult volunteers, 18-50 years of age, who were randomized to receive a single vaccination of MVA-BN RSV or placebo. Volunteers were challenged intranasally with an RSV type A strain 28 days after vaccination. The study demonstrated a significant reduction in viral load in vaccinated subjects (n=30) versus placebo (n=31).
August 22, 2021 - Public Health England published new Guidance: Respiratory syncytial virus (RSV): symptoms, transmission, prevention, treatment. Palivizumab, a monoclonal antibody therapy, is licensed in the U.K. to prevent serious lower respiratory tract infections caused by RSV in infants at high risk of infection.
August 19, 2021 - Pubic Health England published report #33. Out of the 107,928 respiratory specimens reported through the Respiratory DataMart System (based on data received from 14 out of 16 laboratories), 2351 samples were positive for SARS-CoV-2 with an overall positivity of 2.0%. The highest positivity was noted in the 5 to 14-year olds at 4.3% in week 32. The overall influenza positivity remained very low at 0.0% in week 32, with none of the 2,572 samples testing positive for influenza. Respiratory syncytial virus (RSV) positivity decreased, from 15.2% in week 31 to 13.8% in week 32, with the highest positivity noted in the under 5-year olds at 28.0%.
August 16, 2021 - In Mali, a long-acting monoclonal antibody is likely to be cost-effective from both the government and donor perspectives at $3 per dose.
August 3, 2021 - Moderna, Inc. announced that the U.S. FDA had granted Fast Track designation for the mRNA-1345 RSV vaccine candidate.
July 28, 2021 - During Pfizer's investor call on July 28, CSO Mikael Dolsten reported that the company's protein-based RSV vaccine candidate Ad26.RSV preF vaccine was 100% effective in a human challenge trial at preventing mild-to-moderate infection (meaning any infections were asymptomatic).
July 23, 2021 - The CDC reported changes in influenza and other respiratory viruses, including RSV. During January 4–April 4, 2020, the weekly percentage of positive RSV results decreased from 15.3% to 1.4%, then remained at historically low levels (<1.0% per week) for the following year. The weekly percentage of positive RSV results exceeded 3.0% during the previous four years, beginning in October, with peaks ranging from 12.5% to 16.7% in late December. From April 17–May 22, 2021, the weekly percentage of positive results increased from 1.1% to 2.8%. These historic low activity rates are partly due to the COVID-19 pandemic and subsequent implementation of nonpharmaceutical interventions (e.g., cessation of global travel, mask use, physical distancing, and staying home).
July 20, 2021 - The UK NHS reported during week #28, Respiratory Syncytial Virus positivity increased from 6.8% to 8.9%.
June 11, 2021 - The American Hospital Association reported that the CDC alerted clinicians to an increase in Respiratory Syncytial Virus since late March in certain Southern states. The common respiratory virus usually causes mild cold-like symptoms but can be severe, especially for infants and older adults.
June 10, 2021 - The U.S. CDC issued a health advisory to notify clinicians and caregivers about increased interseasonal respiratory syncytial virus (RSV) activity across parts of the Southern United States. In addition, due to this increased activity, CDC encourages broader testing for RSV among patients presenting with acute respiratory illness who test negative for SARS-CoV-2.
July 30, 2020 - A study published by the NEJM found that RSV F protein nanoparticle vaccination in pregnant women did not meet the prespecified success criterion for efficacy against RSV-associated, medically significant lower respiratory tract infection in infants up to date 90 days of life.
February 16, 2021 - GlaxoSmithKline plc announced that patient dosing has begun in Phase III clinical program investigating the immunogenicity, safety, reactogenicity, and persistence of its RSV candidate vaccine for older adults (GSK3844766A).
December 15, 2020 - GeneFirst Gets CE-IVD Mark for Coronavirus, Flu, RSV Combo Test Kit. The test kit, which provides results in under two hours, is PCR system-agnostic and is suitable for use with a range of instruments, including Roche's LightCycler, and Thermo Fisher Scientific's Applied Biosystems 7500, according to a GeneFirst spokesperson.
November 21, 2020 - 'Good progress is being made in RSV prevention research. DURING A VIRTUAL PRESENTATION, Mary T. Caserta, M.D., a pediatrics professor at the University of Rochester Medical Center, updated several RSV investigational products and vaccines in development for infants and pregnant mothers.
November 18, 2020 - According to the Centers for Disease Control and Prevention, virtually all children get an RSV infection at two years old. RSV will often cause a mild, cold-like illness, but it can also cause severe bronchiolitis and pneumonia.
RSV Vaccine Indications
RSV is an RNA virus of the genus Orthopneumovirus, family Pneumoviridae, primarily spread via respiratory droplets when a person coughs or sneezes and through direct contact with a contaminated surface. RSV is the most common cause of bronchiolitis and pneumonia in children under one year of age in the U.S.
In addition, infants, young children, and older adults with chronic medical conditions are at risk of severe disease from RSV infection. Each year in the U.S., RSV infections lead to approximately 500 deaths among children younger than five years old and 14,000 deaths among seniors 65 years or older, says the CDC.
The CDC reported on March 15, 2022, RSV circulation was low during the first year of the COVID-19 pandemic (pre-Delta). In addition, the pattern of RSV codetections during 2021–2022 correlated with trends in RSV circulation observed in other surveillance systems: RSV circulation increased during the summer and fall of 2021 (Delta predominance) and declined during Omicron predominance. These limited data suggest that coinfections did not drive the surge in hospitalizations during Omicron predominance.
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.
Human metapneumovirus (hMPV) is a respiratory pathogen closely related to RSV. It is associated with various illnesses, from mild infection to severe bronchiolitis and pneumonia.
NOTE: The WHO has engaged the Advancing Maternal Immunization (AMI) collaboration to develop a more detailed gap analysis describing the evidence, information, and policy needs of global and country decision-makers, public health program planners implementers who might be involved in decision-making, and introducing maternal RSV vaccines. AMI's companion maternal RSV vaccine roadmap describes near- and mid-to-long-term activities required to generate key evidence and achieve the necessary conditions for advancing RSV maternal immunization in low- and middle-income countries.