Indian Council of Medical Research (ICMR), New Delhi, has invited Expression of Interest (EoI) from eligible organisations, companies, and manufacturers for the Transfer of Technology to develop and commercialise AdFalciVax – a recombinant chimeric multi-stage malaria vaccine against Plasmodium falciparum, the parasite responsible for the deadliest form of malaria. The EoI submission deadline is 17 August 2025.
Key Highlights
- Vaccine Name: AdFalciVax.
- Purpose: Prevent human Plasmodium falciparum infection and reduce community transmission.
- Stage: Early research & development phase — not yet approved for clinical use.
- Commercialisation Mode:
- Non-exclusive licensing to multiple eligible organisations.
- Wider reach to maximise public health benefits.
- Technical Support: ICMR will assist with
- Study planning, product development, protocol drafting, data analysis, efficacy & safety assessment, and validation.
- R&D facilitation through its institutes without financial commitment (unless specified).
About AdFalciVax
- Type: First indigenous recombinant chimeric multi-stage malaria vaccine.
- Target: Two critical stages of Plasmodium falciparum life cycle.
- Production Host: Lactococcus lactis (safe bacterial vector).
- Function:
- Protect individuals from infection.
- Break the vector–human transmission cycle at the community level.
- Make in India Milestone: Fully indigenously developed — aligns with national health security goals.
- Efficacy: Shown excellent results in pre-clinical trials.
Development & Collaborating Institutes
- Lead Agency: ICMR in partnership with DBT–National Institute of Immunology (NII), New Delhi.
- Contributors:
- ICMR–Regional Medical Research Centre, Bhubaneswar (ICMR-RMRCBB): Developed core technology & production process.
- ICMR–National Institute of Malaria Research (ICMR-NIMR): Pre-clinical validation partner.
- NII, New Delhi: Biotechnology and immunology expertise
Significance
- Addresses most lethal malaria strain (Plasmodium falciparum).
- Could contribute significantly to India’s malaria elimination target.
- Reduces reliance on imported vaccines.
- Dual benefit: Individual protection + community transmission control.
Indian Council of Medical Research (ICMR)
- Founded: 1911 (as IRFA – Indian Research Fund Association); renamed ICMR in 1949.
- HQ: New Delhi.
- Function: Apex body for biomedical research in India under the Ministry of Health & Family Welfare.
- Current DG (as of Aug 2025): Dr. Rajiv Bahl.
Malaria in India
- Caused by Plasmodium parasites (P. falciparum, P. vivax, P. malariae, P. ovale).
- P. falciparum causes cerebral malaria and is the most deadly.
- National Framework for Malaria Elimination (2016–2030) aims to eliminate malaria by 2030.
- India is part of WHO’s E-2025 initiative — 25 countries aiming for elimination by 2025.
- Global Malaria Vaccine Landscape:
- RTS,S/AS01 (Mosquirix): First WHO-approved malaria vaccine (targets P. falciparum).
- R21/Matrix-M: Second WHO-approved vaccine (Oxford–Serum Institute of India).
- AdFalciVax would be India’s first indigenous multi-stage recombinant malaria vaccine.
- Plasmodium Life Cycle Stages Targeted by AdFalciVax:
- Pre-erythrocytic stage (sporozoites in liver).
- Blood stage (merozoites infecting red blood cells).
Malaria Vaccines – Comparative Snapshot
| Feature / Parameter | AdFalciVax (India) | RTS,S/AS01 (Mosquirix) | R21/Matrix-M |
| Developer(s) | ICMR + DBT–National Institute of Immunology (NII), with ICMR-RMRCBB & ICMR-NIMR | GlaxoSmithKline (GSK) in partnership with PATH & WHO | University of Oxford + Serum Institute of India |
| Country of Origin | India (Indigenous) | UK (GSK) | UK–India collaboration |
| Type | Recombinant chimeric multi-stage vaccine produced in Lactococcus lactis | Recombinant protein subunit vaccine | Recombinant protein subunit vaccine |
| Target Parasite | Plasmodium falciparum (most lethal strain) | Plasmodium falciparum | Plasmodium falciparum |
| Stages Targeted | Two critical stages: Pre-erythrocytic (liver) + Blood stage | Pre-erythrocytic stage only | Pre-erythrocytic stage only |
| Primary Goal | Prevent infection and reduce vector–human community transmission | Reduce severe malaria cases in children | Reduce severe malaria cases in children |
| Clinical Stage | Pre-clinical trials completed; yet to enter human trials | WHO-approved in 2021; deployed in African countries | WHO-approved in 2023; large-scale African rollout planned |
| Efficacy (Reported) | Excellent pre-clinical efficacy (animal models) | ~30–40% reduction in malaria cases in children after 4 doses | ~75% efficacy in Phase II trials |
| Doses Required | To be finalised after clinical trials | 4 doses + boosters | 3 doses + booster |
| WHO Approval Status | Not yet (Indian R&D stage) | Yes (First malaria vaccine approved by WHO) | Yes (Second malaria vaccine approved by WHO) |
| Special Features | First indigenous multi-stage recombinant malaria vaccine under Make in India | First ever malaria vaccine approved globally | Higher efficacy reported than RTS,S in trials; produced at scale by Serum Institute of India |
| Commercialisation Plan | EoI open till 17 Aug 2025; non-exclusive licensing | Commercial production by GSK; distributed via WHO programmes | Large-scale production in India; targeted for African + endemic markets |