The Indian Council of Medical Research (ICMR) has invited the expression of interest for technology transfer to its malaria anti-malaria vaccine candidate to commercialize that it is developing into partnership with the Department of Biotechnology, even though the vaccine is likely to take at least six to six years for use according to the people familiar with the matter.
According to the approximate time appropriate, “Good Manufacturing Practice (GMP) Productions and Toxicology Studies” will take about two years, according to the estimated timeline; “Stage 1 clinical test, including regulator approval”, will take another two years; “Phase 2B and phase 3 clinical tests” will take about two and a half years; And it will take about six months for post-trial regulatory withdrawal and marketing. (Each stage includes a buffer period of ± six months.)
According to the ICMR, the recipient of the convenor Cimely Multi-Stage Malaria Vaccine (Adfalcivax) is being developed indigenously against Plasmodium Falciparum- parasites that mainly cause severe and fatal malaria. “In the early stages, the vaccine candidates look useful in preventing Plasmodium Falciparum infection in humans and reducing its community transmission,” it said.
Malaria continues serious challenges for public health and economies, especially in tropical and subtropical regions around the world. According to data shared by the government, in 2023, globally, 83 malaria-sustainable countries had approximately 263 million estimated malaria cases, an increase of 11 million cases compared to 2022. India was responsible for half of all the estimated malaria cases in the South-East Asia region in 2023.
ICMR has invited applications from organizations, companies and manufacturers across the country.
“ICMR-Relianial Medical Researe Center, Bhubaneswar (ICMR-RMRCBBb)-One of the Constitution Institutions of the Constitutional Institutions has led the development of a technology, titled ‘a re-convener chimeric multi-stage malaria vaccine (ICMR-NIMR), another Constitution Institute of ICMR, and the National Institute of Immunology (NII), New Delhi, New Delhi, the technology has been operated in collaboration with, a autonomous research institute, New Delhi, an autonomous research institute of the Department of Biotechnology,, Government of India.
Adfalcivax is the first indigenous reconciliation Cimely Malaria Vaccine designed to target two important stages of Plasmodium Falciparum. However, the country’s biomedical research regulator emphasized that the vaccine candidate is in his early research and development stages and is not yet available for any clinical use or commercialization.
The vaccine has shown excellent efficacy in the pre -pricing phase of development, ICMR said in a statement.
“Priclinical data suggests that Adfalcivax may benefit the existing single-phase vaccines (such as RT, S/AS01 and R21/Matrix-M), including: two vulnerable parasitic stages have been said to target the comprehensive safety;
ICMR further stated that it intends to license technology for further development, construction and commercialization under non-exclusive agreements for further development, construction and commercialization. This approach aims to enable wide outreach and maximize public health benefits, and all cooperation will follow ICMR’s intellectual property policy.
ICMR will provide technical assistance through their team of experienced scientists in the study plan, product development, development of the study, results or data analysis, results evaluation, safety and efficacy evaluation, product improvement, etc.
It states that the introduction and rollouts of malaria vaccines, such as RTS, S and R22/Matrix-M, have shown a promise in reducing the incidence of the disease, especially among young children in high-burded areas. While there has been significant progress in combating malaria, the global burden remains sufficient. To address the goal of eradication of malaria, a better vaccine with better efficacy motivates protection against infection in human hosts, as well as a mosquito vector needs to block or reduce transmission.
“In this proposed technique, we have developed a process for the production of P. Falciparum recombinant chimeric malaria antigens (Adfalcivax) … and tested it for better immunozanceta with individual auxiliary yogas. An AIV, such as RTS, S or RTS, S or R21/Matrix -M alone, is stated in the statement.
