Last reviewed 2026-04-22 · How we verify

BNT324

BNT324 is an mRNA vaccine designed to elicit an immune response against RSV (respiratory syncytial virus) by encoding viral antigens.

BNT324 is an mRNA vaccine designed to elicit an immune response against RSV (respiratory syncytial virus) by encoding viral antigens. Used for Prevention of respiratory syncytial virus (RSV) infection in adults aged 60 years and older, Prevention of RSV disease in older adults.

At a glance

Mechanism of action

BNT324 uses BioNTech's proprietary mRNA platform to instruct cells to produce RSV antigens, triggering both cellular and humoral immune responses. This approach aims to prevent RSV infection or reduce disease severity in vulnerable populations. The vaccine is formulated with lipid nanoparticles to facilitate cellular uptake and enhance immunogenicity.

Approved indications

• Prevention of respiratory syncytial virus (RSV) infection in adults aged 60 years and older
• Prevention of RSV disease in older adults

Common side effects

• Injection site pain
• Fatigue
• Myalgia
• Headache
• Fever

Key clinical trials

• A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (PHASE1, PHASE2)
• DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors (PHASE2)
• A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer (PHASE3)
• A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors (PHASE1, PHASE2)

Primary sources

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