Last reviewed 2026-05-15 · How we verify

Cervavac as two dose regimen

Serum Institute of India Pvt. Ltd. · Phase 3 active Biologic

Cervavac as two dose regimen is a Recombinant protein subunit vaccine Biologic drug developed by Serum Institute of India Pvt. Ltd.. It is currently in Phase 3 development for Prevention of cervical cancer caused by HPV types 16 and 18, Prevention of cervical intraepithelial neoplasia (CIN) and other HPV-related precancerous lesions.

Cervavac is a two-dose recombinant protein subunit vaccine that stimulates immune responses against human papillomavirus (HPV) types 16 and 18 to prevent cervical cancer and related precancerous lesions. Used for Prevention of cervical cancer caused by HPV types 16 and 18, Prevention of cervical intraepithelial neoplasia (CIN) and other HPV-related precancerous lesions.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Cervavac as two dose regimen
Sponsor	Serum Institute of India Pvt. Ltd.
Drug class	Recombinant protein subunit vaccine
Target	HPV L1 capsid protein (types 16 and 18)
Modality	Biologic
Therapeutic area	Oncology / Immunology
Phase	Phase 3

Mechanism of action

The vaccine contains recombinant HPV L1 virus-like particles (VLPs) that trigger both humoral and cellular immune responses against the major oncogenic HPV types responsible for approximately 70% of cervical cancers. By inducing neutralizing antibodies and T-cell mediated immunity, the vaccine prevents persistent HPV infection and subsequent malignant transformation of cervical epithelial cells.

Approved indications

Prevention of cervical cancer caused by HPV types 16 and 18
Prevention of cervical intraepithelial neoplasia (CIN) and other HPV-related precancerous lesions

Common side effects

Injection site pain or erythema
Headache
Myalgia
Fever

Key clinical trials

Clinical Study to Evaluate SIIPL QHPV Vaccine (CERVAVAC®) in Women Living with HIV Aged 15-25 Years (PHASE3)

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:

Cervavac as two dose regimen CI brief — competitive landscape report
Cervavac as two dose regimen updates RSS · CI watch RSS
Serum Institute of India Pvt. Ltd. portfolio CI

Frequently asked questions about Cervavac as two dose regimen

What is Cervavac as two dose regimen?

Cervavac as two dose regimen is a Recombinant protein subunit vaccine drug developed by Serum Institute of India Pvt. Ltd., indicated for Prevention of cervical cancer caused by HPV types 16 and 18, Prevention of cervical intraepithelial neoplasia (CIN) and other HPV-related precancerous lesions.

How does Cervavac as two dose regimen work?

What is Cervavac as two dose regimen used for?

Cervavac as two dose regimen is indicated for Prevention of cervical cancer caused by HPV types 16 and 18, Prevention of cervical intraepithelial neoplasia (CIN) and other HPV-related precancerous lesions.

Who makes Cervavac as two dose regimen?

Cervavac as two dose regimen is developed by Serum Institute of India Pvt. Ltd. (see full Serum Institute of India Pvt. Ltd. pipeline at /company/serum-institute-of-india-pvt-ltd).

What drug class is Cervavac as two dose regimen in?

Cervavac as two dose regimen belongs to the Recombinant protein subunit vaccine class. See all Recombinant protein subunit vaccine drugs at /class/recombinant-protein-subunit-vaccine.

What development phase is Cervavac as two dose regimen in?

Cervavac as two dose regimen is in Phase 3.

What are the side effects of Cervavac as two dose regimen?

Common side effects of Cervavac as two dose regimen include Injection site pain or erythema, Headache, Myalgia, Fever.

What does Cervavac as two dose regimen target?

Cervavac as two dose regimen targets HPV L1 capsid protein (types 16 and 18) and is a Recombinant protein subunit vaccine.

Drug class: All Recombinant protein subunit vaccine drugs
Target: All drugs targeting HPV L1 capsid protein (types 16 and 18)
Manufacturer: Serum Institute of India Pvt. Ltd. — full pipeline
Therapeutic area: All drugs in Oncology / Immunology
Indication: Drugs for Prevention of cervical cancer caused by HPV types 16 and 18
Indication: Drugs for Prevention of cervical intraepithelial neoplasia (CIN) and other HPV-related precancerous lesions

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing