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Johnson and Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a breakthrough treatment designated as a research preventive vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract diseases in adults 60 years of age or older.
The company announced that "the name is based on clinical data from Johnson and Johnson's Advanced Vaccine for Preventive Respiratory Syncytial Viruses and may be a substantial improvement over the standard of care available at clinically important endpoints."
The study of preventive vaccines is currently in the phase IIb proof-of-concept study to study the safety and effectiveness of respiratory syncytial virus vaccines in adults aged 65 and over.
“ With no preventive vaccine or effective antiviral treatment available, RSV continues to be a major cause of disease in high-risk groups, especially the elderly," said Johan Van Hoof, regional director and managing director of global treatment at Johnson and Johnson Vaccines and Prevention.
He continued, "Breakthrough treatment solutions represent a clear recognition of the transformative potential of this research-based RSV preventive solution, and the company looks forward to working closely with the FDA throughout the Preventive RSV Advanced Vaccine Development Program." As
, candidate vaccine candidates are now eligible for all relevant FDA functions.RSV is a very common, highly infectious respiratory infection that is the leading cause of bronchitis and pneumonia, affecting more than 64 million people worldwide each year. Because the symptoms of RSV are difficult to distinguish from influenza or other respiratory infections, many people infected with RSV may not be diagnosed correctly. (cyy123.com)