J&J’s (JNJ Quick QuoteJNJ - Free Report) wholly-owned subsidiary Janssen announced the initiation of the phase III EVERGREEN study to evaluate its investigational respiratory syncytial virus (“RSV”) vaccine in patients aged 60 years and above.

The EVERGREEN study will enroll approximately 23,000 patients across multiple countries including North America to evaluate the efficacy, safety and immunogenicity of the vaccine against RSV-associated lower respiratory tract disease (“LRTD”).

The initiation of the EVERGREEN study is based on positive data from the phase IIb CYPRESS study, which evaluated the efficacy and safety of the vaccine against RSV-associated LRTD in vaccinated U.S. adults aged 65 and above. Data from the CYPRESS study will also be presented at the virtual IDWeek 2021.

J&J’s shares have risen 4.2% so far this year in comparison with the industry’s 7% growth.

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RSV is a common and highly contagious disease affecting more than 64 million people yearly throughout the globe. RSV mainly remains undiagnosed since its symptoms are difficult to differentiate from other respiratory infections like COVID-19 and influenza. Currently, there is no approved vaccine or antiviral treatment for RSV.

We remind investors that Janssen’s RSV vaccine has received Breakthrough Therapy Designation from the FDA for the prevention of LRTD caused by RSV in adults aged 60 years and above. The vaccine is also eligible for the European Medicines Agency’s (EMA) priority medicines scheme. Candidates that are granted access to the PRIME scheme receive expedited approval and development support from the EMA.

Please note that several companies are developing vaccines targeting RSV. Last week, Pfizer (PFE Quick QuotePFE - Free Report) also initiated a phase III study to evaluate its RSV vaccine candidate, RSVpreF, in adults aged 60 years and above.

Glaxo (GSK Quick QuoteGSK - Free Report) and Novavax (NVAX Quick QuoteNVAX - Free Report) are also separately evaluating their RSV vaccines in older adults as well as in pediatric population. Their respective RSV candidates are being evaluated in different phase III studies in pregnant women for the given indication.

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