FDA Approves Abrysvo to Treat Adults 18 to 59 Years of Age at Increased Risk of RSV.

The FDA has approved Abrysvo (Pfizer), a respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract infection (LRTD) caused by RSV in people 18 to 59 years of age. .The approval marks the non-valent, bivalent RSV prefusion vaccine F (RSVpreF) as the first RSV vaccine for adults under 50 years of age who are at high risk of RSV-induced LRTD.¹

The study authors noted that approximately 9.5% of US persons aged 18 to 49 have a chronic condition that increases the risk of hospitalization for RSV-related LRTD. This includes obesity, diabetes, chronic obstructive pulmonary disease (COPD), heart failure, chronic kidney disease and asthma. However, that number rises to 24.3% among US adults aged 50 to 64.¹ Abrysvo may provide protection against RSV-LRTD, as the RSV fusion protein is a major target for neutralizing antibodies, according to the study authors.²

Abrysvo previously received FDA approval for the prevention of RSV-LRTD among people 60 years of age and older, infants from birth to 6 months of age, and pregnant women 32 to 36 weeks’ gestation. .²

At the June 2024 meeting, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to update their RSV vaccine recommendations for adults 75 years of age and older, as well as adults with 60 to 74 years old, are at high risk of developing serious diseases. RSV. Vaccination of pregnant women was recommended at the September 2023 ACIP meeting.^1,3

“RSV represents a major threat to young adults with certain chronic conditions. After decades of vaccine research by the scientific community and Pfizer, we now have an opportunity to help reduce the burden of RSV in adults is at high risk,” said Aamir Malik, chief commercial officer in the United States and vice president at Pfizer. in news coverage.¹

The approval was granted based on positive results from the phase 3 clinical trial MONeT (NCT05842967) that evaluated the safety, tolerability, and immunogenicity of Abrysvo among adults with chronic conditions facing increased risk of RSV-related disease.¹

Previous data showed that Abrysvo was tolerated throughout the trial, but a single dose of 120 µg of Abrysvo produced a durable and neutral protective response against RSV-A and RSV-B .² Individuals showed sustained RSV-A and RSV-B responses that were not inferior to the results shown in the phase 3 RENOIR study (NCT05035212) that evaluated the effectiveness of Abrysvo among adults 60 years of age in higher, according to the study authors.³

“With this approval, we are proud that ABRYSVO has become the only RSV vaccine indicated for adults 18 to 49 years of age who are at high risk for the disease, expanding the available indications for people who elders and pregnant women,” Malik said, according to a news release. .¹

ADDED

1. US FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk of Disease. Pfizer. News release. October 22, 2024. Accessed October 23, 2024. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-rsv-vaccine-abrysvor- adults-aged -18.

2. Ferruggia K. A Single Dose of Abrysvo Can Provide Immune Protection Against RSV in Immunocompromised People. Pharmacy Times. August 22, 2024. Accessed October 23, 2024. https://www.pharmacytimes.com/view/single-dose-of-abrysvo-could-provide-immune-protection-against-rsv-in-immunocompromised- individuals.

3. Ferruggia K. New ACIP Recommendations for RSV Vaccines Aim to Solve Problems in Shared Clinical Decision Making. Pharmacy Times. August 30, 2024. Accessed October 23, 2024. https://www.pharmacytimes.com/view/new-acip-recommendations-for-rsv-vaccines-aim-to-solve-challenges-with-shared- clinical-decision-making.