Moderna respiratory syncytial virus mRNA vaccine enters Phase 3 trials
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Moderna respiratory syncytial virus mRNA vaccine enters Phase 3 trials
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Moderna respiratory syncytial virus mRNA vaccine enters Phase 3 trials.
A few days ago, the Phase 2 clinical data of Moderna ‘s respiratory syncytial virus (RSV) mRNA vaccine, mRNA1345 , was officially opened for Phase 3 clinical trials after being reviewed by an independent data and safety monitoring committee.
Moderna expects to enroll approximately 34,000 people in Phase 3 clinical trials in multiple countries.
RSV causes severe disease burden in older adults and young children; there is no approved vaccine to prevent RSV.
Respiratory syncytial virus (RSV) is a common respiratory virus that usually causes cold-like symptoms.
While most people infected with RSV recover in about one to two weeks, the virus can be serious in young children and the elderly.
For these high-risk groups, RSV is the leading cause of severe respiratory illness including pneumonia and respiratory distress.
The disease burden caused by RSV is enormous. In the United States alone, RSV causes approximately 177,000 hospitalizations and 14,000 deaths in adults 65 and older each year, with an estimated annual healthcare cost of $3 billion.
In June 2021, the CDC issued a health alert about an increase in seasonal RSV infections in some parts of the United States, and a similar trend is seen globally. But there is no approved RSV vaccine yet.
Stéphane Bancel , CEO of Moderna, said that RSV is one of the most widespread respiratory viruses that can cause severe illness and hospitalization in the elderly, but there is no vaccine available on the market.
Prevent more than 1 million infections worldwide, thereby improving the quality of life of people at high risk of infection and reducing the burden on healthcare systems.
The ultimate goal is to combine the RSV mRNA vaccine with the COVID-19 mRNA vaccine and the influenza mRNA vaccine into a single-dose booster vaccine combination.
The RSV mRNA vaccine , mRNA1345 , encodes the prefusion F glycoprotein of respiratory syncytial virus, which elicits higher neutralizing antibody responses than the postfusion state.
The vaccine uses the same lipid nanoparticles (LNPs) as Moderna’s COVID-19 mRNA vaccine as a delivery vehicle and contains optimized protein and codon sequences.
Prior to this, the FDA had granted it Fast Track designation.
The main purpose of this phase III clinical trial is to determine the safety and efficacy of the vaccine in adults over 60 years old, so as to obtain marketing authorization.
References :
https://investors.modernatx.com/news/news-details/2022/Moderna-Initiates-Phase-3-Portion-of-Pivotal-Trial-for-mRNA-Respiratory-Syncytial-Virus-RSV-Vaccine-Candidate-Following-Independent-Safety-Review-of-Interim-Data/default.aspx
Moderna respiratory syncytial virus mRNA vaccine enters Phase 3 trials
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