CII pharma summit 2025- Rajesh jain on dengue vaccine immunization completion update
At the 7th CII Pharma & Life Sciences Summit 2025 held in New Delhi on 12 December 2025, the key public update on the dengue vaccine linked to Dr Rajesh Jain (Panacea Biotec) is as follows:
1. Status of the Panacea Biotec dengue vaccine (DengiAll)
- DengiAll is a single‑shot, tetravalent dengue vaccine developed by Panacea Biotec in collaboration with the US NIH and in partnership with ICMR. Phase I/II trials with 3‑year safety follow‑up were completed earlier. (dcvmn.org)
- A large Phase III trial across ~19–20 sites in India (target ~10,300–10,500 adult participants) began in August 2024 after DCGI approval for the trial. (dcvmn.org)
- As of mid‑2025, ~70% of enrolment was completed, with ICMR indicating enrolment would finish by October 2025. (morungexpress.com)
2. Update announced at CII Pharma Summit 2025
- At the 7th CII Pharma & Lifesciences Summit 2025 on 12 December 2025, Union Minister Jitendra Singh highlighted Panacea Biotec’s single‑shot dengue vaccine and stated that it has “recently completed a phase‑three trial involving 11,000 participants.” (tribuneindia.com)
- This implies that the Phase III clinical trial phase is now substantially completed, at least in terms of enrolment and dosing; detailed data analysis and regulatory review will still take time.
3. What this means for immunisation and completion timelines
- As of 13 December 2025, there is no public announcement that DCGI/CDSCO has granted full marketing approval for DengiAll; approvals so far relate to conduct of Phase III trials, not commercial use. (hindustantimes.com)
- Earlier public comments from Dr Rajesh Jain indicated Panacea Biotec aims to launch the dengue vaccine within about 2–3 years of Phase III initiation, subject to successful data and regulatory clearance. (businessupturn.com)
- Even after licensure, national immunisation “completion” is much further out:
- Trial participants are expected to be followed for up to two years for efficacy and safety before final data submission to CDSCO. (hindustantimes.com)
- Only after DCGI/CDSCO approval can the vaccine be considered for inclusion in any government‑run immunisation programmes (e.g., under MoHFW/National Programme for Vector Borne Diseases). That process has not yet been announced.
- So, in strict terms:
- Phase III trial – reported as recently completed (≈11,000 subjects).
- Regulatory approval – pending.
- Public immunisation roll‑out / completion – no official timeline yet.
4. Relevance for investors in Panacea Biotec (illustrative, not advice)
- Panacea Biotec’s stock has reacted positively in the past to news about the dengue vaccine timeline (e.g., an intraday rally in October 2024 when management talked of a potential launch in about two years). (business-standard.com)
- From a sector/investor perspective, DengiAll represents:
- A first‑in‑India dengue vaccine opportunity, if approved.
- High regulatory and execution risk, given stringent safety/efficacy requirements and multi‑year follow‑up.
- Any investment decision would need to factor in: trial outcomes, DCGI/CDSCO review, pricing, competition (global dengue vaccines), and inclusion in public programmes.
In summary, the CII Pharma Summit 2025 update is that Panacea Biotec’s single‑shot dengue vaccine has just completed Phase III enrolment and dosing (~11,000 participants), but India has not yet begun or scheduled mass dengue immunisation with this vaccine, and no completion date for immunisation can be stated today.
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