Pharma Focus America

FDA Grants Approval to ABRYSVO™, Pfizer's Vaccine for Preventing Respiratory Syncytial Virus (RSV) in Older Adults

Pfizer Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its vaccine called ABRYSVO™ (Respiratory Syncytial Virus Vaccine) to prevent lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV) in individuals aged 60 and above. ABRYSVO is a unadjuvanted bivalent RSV prefusion F (RSVpreF) vaccine that contains two preF proteins selected to offer optimal protection against RSV A and B strains. The vaccine has demonstrated safety and efficacy.

Dr. Annaliesa Anderson, Senior Vice President and Chief Scientific Officer of Vaccine Research and Development at Pfizer, expressed the significance of this approval in addressing the burden of RSV among older adults and fulfilling Pfizer's commitment to public health. She acknowledged the contributions of clinical trial participants, study investigators, and Pfizer employees in making the vaccine available.

The FDA's decision was based on data from the Phase 3 clinical trial named RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease) (NCT05035212). RENOIR is a global study that enrolled approximately 37,000 participants aged 60 and above and evaluated the efficacy, immunogenicity, and safety of a single dose of ABRYSVO. The trial results were published in The New

England Journal of Medicine, and additional data is being collected during the ongoing second RSV season.

RSV is a highly contagious virus known for causing respiratory illnesses worldwide. It can lead to severe illness and even death, particularly in older adults and individuals with underlying health conditions. RSV-related disease severity tends to increase with age and the presence of comorbidities such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.

The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will convene on June 21, 2023, to discuss recommendations for the use of RSV vaccines in older adults. Pending the outcome of this meeting, Pfizer anticipates making the vaccine available in the third quarter of 2023, ahead of the upcoming RSV season in the fall.

Pfizer has also reported positive preliminary results from a Phase 3 study examining the safety and immunogenicity of ABRYSVO when coadministered with seasonal inactivated influenza vaccine (SIIV) in adults aged 65 and above. The company plans to publish these results in a peer-reviewed scientific journal. Additionally, Pfizer has announced plans to conduct multiple clinical trials evaluating the use of RSVpreF in different populations, including healthy children

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