Abrysvo is a bivalent RSV prefusion F (RSVpreF) unadjuvanted vaccine that contains two preF proteins to optimise the protection against RSV A and B strains, indicated to prevent RSV disease in people aged 60 years and above
Pfizer secures FDA approval for Abrysvo. (Credit: Willfried Wende from Pixabay)
Pfizer has received the US Food and Drug Administration (FDA) approval for the Abrysvo vaccine to prevent disease caused by respiratory syncytial virus vaccine (RSV) in people aged 60 years and above.
Abrysvo is a bivalent RSV prefusion F (RSVpreF) unadjuvanted vaccine that contains two preF proteins to optimise the protection against RSV A and B strains.
RSV is an infectious virus and a common cause of respiratory illness globally. It affects the lungs and breathing passages of an individual, potentially causing severe illness or death.
The severity of RSV disease can increase with age and comorbidities, such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.
The US Centres for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet this month to discuss the proper use of RSV vaccines in older adults.
Pfizer intends to roll out the vaccine in Q3 2023 before the anticipated RSV season this fall, subject to the outcome of the ACIP meeting.
Pfizer vaccine research and development senior vice president and chief scientific officer Annaliesa Anderson said: “Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults.
“ABRYSVO will address a need to help protect older adults against the potentially serious consequences of RSV disease.
“We are extremely grateful to the clinical trial participants, study investigator teams and our dedicated Pfizer colleagues for their roles in making this vaccine available.”
The FDA approval of the vaccine is based on data from the ongoing Phase 3 RENOIR clinical trial, which evaluates the efficacy, immunogenicity, and safety of Abrysvo in around 37,000 participants.
Earlier this month, Pfizer announced positive results from the Phase 3 study evaluating Abrysvo co-administered with seasonal inactivated influenza vaccine (SIIV) in older adults.
The company also announced its plans to initiate multiple clinical trials evaluating RSVpreF in participants who are at high risk due to underlying medical conditions.
In March last year, US FDA granted Breakthrough Therapy Designation for Abrysvo, after accepting the company’s Biologics License Application (BLA) under priority review.
In February this year, the European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for RSVpreF, under accelerated assessment.
In April, Health Canada accepted RSVpreF for review for both individuals ages 60 and older and as a maternal immunization to help protect infants against RSV.
RENOIR principal investigator Edward E Walsh said: “This past RSV season demonstrated the serious consequences and potential health risks this virus poses for older adults.
“Today’s FDA approval of Abrysvo recognises significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease.”