Pfizer (NYSE:PFE) said that the U.S. FDA granted the company’s vaccine candidate targeted at respiratory syncytial virus PF-06928316 (RSVpreF) a Breakthrough Therapy designation.
The Breakthrough Therapy designation is meant to speed up the development and review process for treatments focused on serious or life-threatening conditions. The agency’s decision is based on a proof-of-concept Phase 2a study carried out by Pfizer.
The market for an RSV vaccine could be sizable, as there are currently no therapeutic or preventive options available for older adults with the disease. RSV is estimated to cause around 14,000 deaths in the U.S. every year.
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