Zika disease, a viral infection, is mostly a mosquito-borne disease transmitted by Aedes mosquitoes. It can also be transmitted to foetus during pregnancy, through sexual contact, blood transfusion and organ transplantation. The disease is usually mild and requires no specific treatment. However, it is more serious when infection occurs during pregnancy which may cause microcephaly and other congenital malformations in the infant, preterm birth and miscarriage. Few cases may also develop Guillain-Barré syndrome which is a neurological disorder.

In India, Zika cases have been reported from several states. According to Ministry of Health, Govt of India (https://mohfw.gov.in/?q=pressrelease-32), as on 22 July 2024, there are 537 Zika cases have been registered.

Emerging infectious disease are whose incidence has increased recently and could increase in the near future. The minority that are capable of developing efficient transmission between humans can become major public and global concerns as potential causes of epidemics or pandemics.

Currently there is no vaccine available for its prevention. IIL partnered with Griffith University, Australia to develop the codon de-optimized live attenuated Zika vaccine that has completed extensive pre-clinical evaluations and received permission from Indian regulatory authority to produce GMP grade materials for clinical developmental work.

As per the MoA, Indian Council of Medical Research (ICMR) will fund the Phase I clinical trial costs including the costs relating to the conduct, investigations and monitoring of clinical trial. The trial will be conducted at the ICMR network sites in India.

Speaking on the occasion, Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited said, “It is a great moment for IIL to collaborate with ICMR to develop Zika vaccine. IIL has been the single largest contributor to India achieving self-sufficiency in the field of vaccines. Our foresight on the development of novel vaccine platforms including codon de-optimized viral vaccines is beginning to bear fruit. It is essential to safeguard our people from emerging diseases by developing safe and effective vaccines that are affordable“.

Dr. Rajiv Bahl, DG-ICMR said “ICMR’s Phase I trial network, launched last year, facilitates first-in-human safety studies for innovative and affordable Frontier MedTech, including small molecules, biologics, and vaccines. With four Phase-I sites—ACTREC Mumbai, KEM Hospital Mumbai, SRM Chennai, and PGIMER Chandigarh—fully operational, Indian innovators no longer need to go abroad for Phase-I trials. This is a significant step towards achieving Atmanirbhar Bharat and Viksit Bharat.

Dr. Priyabrata Pattnaik, Deputy Managing Director, Indian Immunologicals Limited added “We have been in the forefront of developing vaccine for emerging viral diseases. Currently we are working on developing vaccines for several neglected emerging diseases. Zika, Kyasanur Forest Disease (KFD), Chikungunya, SARS-CoV-2 intra-nasal booster vaccine are to name a few”.

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New Delhi, 29^th August 2024 – Indian Immunologicals Limited (IIL), a leading vaccine manufacturer, has announced partnership with Central Institute of Brackishwater Aquaculture (CIBA), Chennai, an Indian Council of Agricultural Research (ICAR) Institute for the commercial development of a recombinant monovalent viral nervous necrosis vaccine for finfish developed by CIBA.

IIL ventured into aqua business in October 2022 by launching products for aquaculture health market dealing with pond management and fish or shrimp gut management and subsequently announced commercial development of fish vaccines with ICAR’s CIFE, Mumbai and CIFA, Bhubaneswar. India is the 3^rd largest fish producer in the global sphere and more than 65% of India’s fish is through Inland Fisheries and Aquaculture. The main constraint to aquaculture globally, however, is disease with an estimate that 20% of all cultured aquatic animals are lost because of infectious diseases, amounting to >10 billion USD in losses annually on a global scale.

Viral nervous necrosis (VNN) or viral encephalopathy and retinopathy (VER) is an acute viral disease affecting several species of marine, brackishwater and freshwater fishes. The disease causes up to 100% mortality in larval and early juvenile stages. Adult fish when infected, is asymptomatic, but can transmit the virus to the offspring through eggs and gonadal fluids.

Speaking on the occasion, Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited said, “IIL is the first in India to get to fish vaccines. We are covering different kind of fishes (fresh water, brackish water, etc.) and culture conditions (pond, cage culture, etc.) and are aware of the challenges associated with being the first, having been in similar situations for many other livestock vaccines. We are working at multiple fronts in defining pathways for commercial development of fish vaccines in India“.

Dr. Priyabrata Pattnaik, Deputy Managing Director, Indian Immunologicals Limited added “IIL as a leading “One Health” organization is committed to developing vaccines for different fish pathogens with a long-term strategic objective of reducing use of antibiotics in aquaculture there by antimicrobial resistance in environment”.

Dr. Kuldeep K. Lal, Director, ICAR-CIBA said “viral nervous necrosis is a major threat for brackishwater aquaculture. The VNN vaccine developed by CIBA can prevent vertical transmission of the disease to the offsprings and prevent mortality in fingerlings. The vaccine can play a significant role in controlling the loss due to VNN in India and other Asian countries”.

Aquaculture in India suffers economic losses due to infections caused by several bacterial, viral, fungal, and other aetiological agents. Currently these infections are being managed by anti-infectives and other conventional measures with varying degree of success. With the rising concern pertaining on anti-microbial resistance (AMR) and chemical free food products both at global and domestic platforms, there is a growing need for better control measures against these infections. Currently there is no fish vaccines available in India on a commercial scale to prevent aquaculture infections.

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 Hyderabad, 27^th August 2024 – Indian Immunologicals Limited (IIL), a leading vaccine manufacturer, has announced live-attenuated needle free intra-nasal booster vaccine developed against SARS-CoV-2 using codon deoptimization technology in collaboration with Griffith University, Australia. This groundbreaking work on Covid-19 vaccine has been published in the world’s leading science Journal ‘Nature Communications’ on 26^th August 2024.

The danger due to COVID 19 is still not over. It is still killing around 1,700 people a week around the world. World Health Organization urge people at-risk to keep up with their vaccinations with boosters.

Among different formats of vaccines available, it is well known that live attenuated vaccine generates a robust and broad-spectrum neutralizing antibody response. IIL’s needle free intra-nasal booster vaccine against SARS-CoV-2 developed using codon deoptimization technology demonstrated remarkable stability and maintained safety in extensive animal studies.

Codon deoptimization involves decreasing the frequency of underrepresented codon pairs (genetic determinant for amino acids) without changing amino acid sequences. It is a highly efficient virus attenuation strategy that utilizes suboptimal codon pairs to achieve attenuation of recoded viruses. Virtually all the viruses can be attenuated by this method. Degree of attenuation can be regulated from 1-100% as required. It is extremely safe and less time-consuming than the conventional way of attenuating viruses which usually takes several years. Completely guided attenuation and the means are well known, and attenuated virus is expected to present all the antigens and mimics natural infection.

Speaking on the occasion, Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited said, “This accomplishment signifies a major step forward in our battle against COVID-19. The development of this vaccine not only highlights our dedication to innovation in public health but also demonstrates IIL’s capability in adopting novel technology. We are enthusiastic about the codon de-optimization technology, and it’s use in targeted attenuation of microorganisms to be used as vaccine candidate”.

He mentioned that “Our pioneering intranasal vaccine is poised to revolutionize the fight against infectious diseases, and by facilitating non-invasive immunization, we aim to enhance vaccination rates, ultimately safeguarding more individuals and communities.”

Dr. Priyabrata Pattnaik, Deputy Managing Director, Indian Immunologicals Limited added “This is a perfect example of Industry-Academia collaboration translating concepts to products for the benefit of people at large. Our R&D team has dedicated immense effort to the creation of this innovative vaccine, and we take pride in its proven safety and efficacy in generating a protective immune response with just a single dose“.

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