Respiratory Syncytial Virus (RSV) Vaccines
The development of respiratory syncytial virus (RSV) vaccines has been identified as a priority for the WHO Initiative for Vaccine Research. However, as of November 18, 2021, the U.S. CDC says there are no Approved RSV vaccines in the USA.
Results from a study published in the Journal of the Pediatric Infectious Diseases Society showed about 59,00 cases of community-onset RSV-associated hospitalizations occurred among children aged <2 years old during the 2014-2015 RSV season. The World Health Organization states that there are 64 million infections and 160,000 deaths annually from RSV.
The RSV vaccine market is expected to be worth $4.2 billion by 2027.
RSV Vaccine Candidates
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.
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 response to an RSV infection.
Meissa Vaccines MV-012-968 is an investigational, live attenuated vaccine for protection against respiratory syncytial virus infection.
ResVax is a vaccine candidate 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 respiratory syncytial virus (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.
Ad26.RSV preF vaccine is a protein-based RSV vaccine candidate being tested on adults produced by Pfizer, Inc.
RSV Vaccine News
November 18, 2021 - Moderna, Inc. announced the first participant has 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 UK'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 UK 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 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. During the previous four years, the weekly percentage of positive RSV results exceeded 3.0%, 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 yesterday 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 serious, 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.
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.
A medication called SYNAGIS (palivizumab) is available to prevent severe RSV illness in certain infants and children at high risk for severe disease. This medication can help prevent serious RSV disease, but it cannot help cure or treat children already suffering from serious RSV disease, and it cannot prevent infection with RSV.
In the UK, Palivizumab, a monoclonal antibody therapy, is licensed to prevent serious lower respiratory tract infections caused by RSV in infants at high risk of infection.
Human metapneumovirus (hMPV) is a respiratory pathogen closely related to RSV. It is associated with a range of 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.