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FDA priority review given to Pfizer’s RSV vaccine for older adults

Published on 09/12/22 at 10:40am

Pfizer has announced that the FDA has accepted its application for a respiratory syncytial virus (RSV) vaccine for older adults, with the FDA expected to come to a decision by Spring 2023. The FDA will review the application under the priority review programme, meaning the approval timeline should be reduced by four months.

Pfizer has already announced that its RSV vaccine is at least 85% effective in preventing severe lower respiratory tract illnesses in older adults. There is currently no RSV vaccine available, so if approved, this vaccine would mark a huge step forward in protecting older adults.  

Typically, RSV circulates during the colder months – much like the flu – however it has been more significant than usual this year, causing a rise in respiratory infections and overwhelming many hospitals. In healthy adults and older children, RSV generally only causes mild, cold-like symptoms, but it can be considerably more severe in older adults and infants.

Annaliesa Anderson, head of Pfizer’s vaccine research and development, commented: “With no RSV vaccines currently available, older adults remain at risk for RSV disease and potential severe outcomes, including serious respiratory symptoms, hospitalisation, and in some cases, even death. The FDA’s acceptance of the BLA for our RSV vaccine candidate is an important regulatory milestone in Pfizer’s efforts to help protect older adults against RSV and demonstrates additional progress toward what has been an elusive public health goal – reducing the overall burden associated with this infectious disease.”

 

Betsy Goodfellow


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