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

The FDA approved Abrysvo (Pfizer), a respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 18 through 59 years. The approval marks the unadjuvanted, bivalent RSV prefusion F (RSVpreF) vaccine as the first and only RSV vaccine designated for adults younger than 50 that are at increased risk for LRTD triggered by RSV.¹

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Study authors noted that approximately 9.5% of US individuals aged 18 to 49 years have an underlying chronic condition that increases their risk of developing and being hospitalized for RSV associated 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 individuals aged 50 to 64 years of age.¹ Abrysvo could provide protection against RSV-LRTD, as the RSV fusion protein is a major target of neutralizing antibodies, according to study authors.²

Abrysvo has previously received FDA approval for the prevention of RSV-LRTD among individuals 60 years and older, infants from birth up to 6 months, and pregnant individuals at 32 weeks through 36 weeks gestational age.²

At the June 2024 meeting, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to update their recommendation of RSV vaccines for adults aged 75 years and older, as well as adults aged 60 to 74 years, that are at an increased risk for severe RSV. The maternal immunization was recommended at ACIP’s September 2023 meeting.^1,3

“RSV represents a significant threat to younger adults with certain chronic conditions. After decades of vaccine research by the scientific community and Pfizer, we now have the opportunity to help alleviate the burden of RSV in this high-risk adult population,” Aamir Malik, chief commercial officer in the US and executive vice president at Pfizer, said in a news release.¹

The approval was granted based on positive results from the phase 3 MONeT clinical trial (NCT05842967) that assessed the safety, tolerability, and immunogenicity of Abrysvo among adults with underlying chronic condition that face an increased risk of RSV-associated disease.¹

Previous data displayed that Abrysvo was tolerated throughout the trial, but a single 120 µg dose of Abrysvo produced a durable and neutralizing response to protect against RSV-A and RSV-B.² Individuals displayed RSV-A and RSV-B neutralizing responses non-inferior to the results displayed in the phase 3 RENOIR (NCT05035212) study that assessed the efficacy of Abrysvo among adults 60 years and older, according to study authors.³

“With this approval, we are proud that ABRYSVO is now the only RSV vaccine indicated for adults aged 18 to 49 at increased risk for the disease, expanding on its existing indications for older adults and pregnant women,” said Malik, in a news release.¹

REFERENCES

1. U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for 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. Single Dose of Abrysvo Could Provide Immune Protection Against RSV in Immunocompromised Individuals. Pharmacy Times. August 22, 2024. Accessed Ocotber 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 Challenges With 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.