Last reviewed · How we verify
Bivalent Vaccines
Bivalent vaccines stimulate immune responses against two distinct pathogenic targets or variants simultaneously.
Bivalent vaccines stimulate immune responses against two distinct pathogenic targets or variants simultaneously. Used for Influenza prevention (bivalent formulations), COVID-19 prevention (bivalent formulations against original and variant strains).
At a glance
| Generic name | Bivalent Vaccines |
|---|---|
| Also known as | CERVARIX |
| Sponsor | Instituto Nacional de Salud Publica, Mexico |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Bivalent vaccines are formulated to contain antigens from two different pathogens or two variants of the same pathogen, enabling the immune system to generate protective antibodies and cellular responses against both targets in a single vaccination. This approach is commonly used for influenza (seasonal strains) and COVID-19 (original strain plus variant) vaccines to broaden immunological coverage.
Approved indications
- Influenza prevention (bivalent formulations)
- COVID-19 prevention (bivalent formulations against original and variant strains)
Common side effects
- Injection site pain or swelling
- Fatigue
- Headache
- Myalgia
- Low-grade fever
Key clinical trials
- Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial (PHASE4)
- A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose (PHASE3)
- A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma (PHASE2)
- A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma (PHASE2)
- TARSILA Real-World Evidence Study
- Strengthening HPV Immunization Through EPI Leveraged Delivery (PHASE2)
- Lymph Node Aspiration to Decipher the Immune Response of Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine. (NA)
- Extended Follow-up of Women Who Received One, Two, and Three Doses of the HPV Vaccine in the Costa Rica Vaccine Trial (CVT), ESCUDDO-CVT Study
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bivalent Vaccines CI brief — competitive landscape report
- Bivalent Vaccines updates RSS · CI watch RSS
- Instituto Nacional de Salud Publica, Mexico portfolio CI