ICMR invites EOI from vaccine manufacturers to develop vaccine against Kyasanur Forest Disease

Mumbai, February 25, 2023 :

The Indian Council of Medical Research (ICMR) has invited Expression of Interest (EOI) from experienced vaccine manufacturers, pharma companies and R&D institutions for undertaking R&D activities using Kyasanur Forest Disease Vaccine (KFDV) isolate for development of vaccine against KFD and its manufacturing or commercialization.

ICMR – National Institute of Virology (NIV) Pune has isolated and characterized KFDV isolates from the recent outbreaks of KFD in Karnataka State for development of a new vaccine candidate which is intended to have higher efficacy and safety of the recipients.

KFD is a highly infectious viral illness transmitted by infected ticks through contact with monkeys and other wild animals. Till date there is no definite treatment available for KFD. Hence, vaccination is considered to be an important public health intervention to control KFD.

Intramuscular administration of formalin inactivated indigenous KFD vaccine to the susceptible population has been found to drastically reduce the percentage of incidences. As the vaccine-induced immunity is short-lived, the first booster dose is recommended in about 6 months to 9 months after the primary vaccination; thereafter, administration of the annual booster dose is recommended for five years after the last confirmed case in the area. However, recent data show recurrence of KFD cases even in the vaccinated subjects, which may probably be due to the suboptimal efficacy of the current vaccine or vaccination protocol. Additionally, the vaccine associated side effects, such as pain, and administration of booster doses for five years are also believed to be some of the potential discouraging factors that might affect the vaccine acceptability.

Interested companies or manufacturers with demonstrated capabilities in vaccine manufacturing are invited to join hands with ICMR for development and validation of vaccine candidates. Under this EoI, the manufacturers or companies which are responsive and fulfilling all the technical needs will be shortlisted based on their R&D plan, facilities, capabilities and demonstrated experience in vaccine manufacturing. On short listing of technically suitable companies, one Request for Proposal (RFP) will be shared with the shortlisted candidates. At the RFP stages, technically suitable candidates will be required to provide complete technical details along with their financial proposal with reference to upfront payment and royalty component, in line with the applicable revenue sharing policy of ICMR. Selection of candidates will be decided on the basis of their offers at the RFP stage. Qualified companies or manufacturers will only be contacted for execution of MoA/MoU/Agreement for partnership, collaboration or technology transfer.

The EOI Document containing the details of qualification criteria, submission details, brief objective, scope of work and evaluation criteria can be downloaded from the ICMR website (https://www.icmr.gov.in). The EOI may be submitted through email to jitendra.narayan@gov.in. Shortlisted firm(s)/organization(s) shall only be contacted for the further process.

ICMR reserves the right to cancel this EOI and/or invite afresh with or without amendments, without liability or any obligation for such EOI and without assigning any reason. Information provided at this stage is indicative and ICMR reserves the right to amend/add any further details in the EOI, as may be desired by the competent authority at ICMR and duly notified on its website

Currently, there are no treatment options available and the inactivated whole virus vaccine is not sufficiently efficacious to control KFDV infection and to reduce the burden on India’s public health system.

The seed virus used for the current KFD vaccine P9605 was isolated in 1965 and has undergone several passages in mice. The current vaccine is a formalin inactivated and does not have the WHO approval. Also the current vaccine that was developed based on the strain isolated in early 1970s and does not seem effective against the current circulating strain of KFD. Pharmabiz