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Pfizer receives Breakthrough Therapy Designation from FDA for RSV vaccine candidate

There are currently no preventative, therapeutic or vaccine options for older adults diagnosed with RSV


Pfizer has announced that the US Food and Drug Administration (FDA) has granted its respiratory syncytial virus (RSV) vaccine candidate a Breakthrough Therapy Designation.

The vaccine has been developed for the prevention of lower respiratory tract disease caused by RSV in patients 60 years of age or older.

There are currently no preventative, therapeutic or vaccine options for older adults diagnosed with RSV.

RSV is a contagious virus and is a common cause of respiratory illness, with the ability to affect patients’ lungs and breathing passages. The condition can be potentially life-threatening for young infants, children with chronic medical conditions and older adults.

RSV infections account for approximately 177,000 hospitalisations and 14,000 deaths each year in the US alone among older adults. For children under the age of five, approximately 2.1 million outpatient visits and 58,000 hospitalisations occur each year in the US.

The FDA’s decision was based on the positive results of a phase 2a study assessing the safety, immunogenicity and effectiveness of a single dose of the vaccine in healthy adults aged 18 to 50.

Pfizer announced the launch of RENOIR (RSV vaccine Efficacy study iNOlder adults Immunised against RSV disease) in September 2021 – a phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of RSVpreF, in adults ages 60 years or older, which remains ongoing.

Kathrin Jansen, senior vice president and head of vaccine research and development at Pfizer, said: “The clinical and economic burden of RSV represents a critical need... [and the FDA’s decision] is a significant step forward in our efforts to help protect vulnerable populations, particularly older adults, against certain potentially serious respiratory illnesses, including RSV.”

The purpose of the FDA’s Breakthrough Therapy Designation is to efficiently process the development and review of drugs and vaccines that are intended to treat or prevent serious conditions. Additionally, preliminary clinical evidence indicates that the drug or vaccine may show substantial improvement over available treatment on a clinically crucial endpoint.

Article by
Fleur Jeffries

24th March 2022

From: Regulatory



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