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FDA Approves Abrysvo RSV Vaccine for Adults at Increased Risk
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Key Takeaways
- Abrysvo is now approved for adults aged 18-59 years at increased risk for RSV due to chronic conditions, expanding its previous indications.
- The FDA's decision is based on a phase 3 trial showing safety and efficacy in adults with chronic conditions.
Abrysvo is the first and only respiratory syncytial virus (RSV) vaccine indicated for adults younger than 50 years.
The FDA has approved Pfizer’s respiratory syncytial virus (RSV) vaccine, Abrysvo, for adults aged 18 to 59 years who are at increased risk for the disease.1
“RSV represents a significant threat to younger adults with certain chronic conditions,” Aamir Malik, chief US commercial officer and executive vice president, Pfizer, said in a statement. “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. 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.”
On March 24, 2022, the FDA granted Breakthrough Therapy Designation for Abrysvo for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older.2 Since then, Pfizer has worked to expand the vaccine’s reach in immunocompromised adults. In August, Pfizer announced top-line results of Abrysvo being well-tolerated and effective in generating strong neutralizing responses in adults aged 18 years and older.3
On June 26, 2024, the CDC’s Advisory Committee on Immunization Practices (ACIP) updated its recommendations that all adults aged 75 and older and adults aged 60 to 74 years who are at increased risk for severe RSV should receive a single dose of the RSV vaccine (Arexvy [GSK], Abrysvo [Pfizer], or mResvia [Moderna]).4
The FDA’s most recent decision on Abrysvo is based on inferred efficacy from the pivotal phase 3 clinical trial (NCT05842967), which investigated the safety, tolerability, and immunogenicity of the vaccine in adults at risk of RSV-associated disease due to certain chronic medical conditions.1
Among all US adults aged 18 to 49 years, 9.5% have an underlying chronic condition, such as obesity, diabetes, chronic obstructive pulmonary disease (COPD), heart failure, chronic kidney disease, and asthma, putting them at increased risk of developing and being hospitalized for RSV-associated LRTD. This risk is exacerbated by 24.3% of all US adults aged 50 to 64.
Abrysvo is indicated in the US for the prevention of LTRD caused by RSV in adults aged 60 years and older, the prevention of LTRD caused by RSV in adults aged 18 through 59 years who are at increased risk for LRTD caused by RSV, and pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe RSV caused by RSV in infants from birth through 6 months of age.
The most reported adverse reactions in pregnant individuals were pain at the injection site (40.6%), headache (31%), muscle pain (26.5%), and nausea (20%). In individuals aged 60 years and older, fatigue (15.7%), headache (12.9%), pain at the injection site (10.7%), and muscle pain (10.2%) were the most reported adverse reactions. Among those aged 18 through 59 years, the most common adverse reactions were pain at the injection site (35.3%), muscle pain (24.4%), joint pain (12.4%), and nausea (11.8%).5
References
1. US FDA approves Pfizer’s RSV vaccine Abrysvo for adults aged 18 to 59 at increased risk for disease. Pfizer Inc. News release. October 22, 2024. Accessed October 23, 2024. https://www.businesswire.com/news/home/20241018199265/en/U.S.-FDA-Approves-Pfizer%E2%80%99s-RSV-Vaccine-ABRYSVO%C2%AE-for-Adults-Aged-18-to-59-at-Increased-Risk-for-Disease.
2. US FDA approves Abrysvo, Pfizer’s vaccine for the prevention of respiratory syncytial virus (RSV) in older adults. Pfizer Inc. News release. May 31, 2023. Accessed October 23, 2024. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-abrysvotm-pfizers-vaccine-prevention#:~:text=On%20March%2024%2C%202022%2C%20Pfizer,years%20of%20age%20and%20older.
3. Steinzor P. Pfizer reports positive phase 3 results for RSV vaccine in immunocompromised adults. AJMC. August 15, 2024. Accessed October 23, 2024. https://www.ajmc.com/view/pfizer-reports-positive-phase-3-results-for-rsv-vaccine-in-immunocompromised-adults.
4. Steinzor P. Updated ACIP guidelines: RSV vaccine for adults aged 60 years and older. AJMC. August 7, 2024. Accessed October 23, 2024. https://www.ajmc.com/view/updated-acip-guidelines-rsv-vaccine-for-adults-aged-60-years-and-older.
5. Abrysvo. Package insert. Pfizer Inc; 2024. Accessed October 23, 2024. https://labeling.pfizer.com/ShowLabeling.aspx?id=19589.
