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NEW DELHI : A top government panel has recommended that Bharat Biotech Ltd conduct phase-3 trials of its Japanese encephalitis vaccine for people aged 65 and above, as the disease emerges as a key concern in India. The Hyderabad-based company had asked the Drugs Controller General of India (DCGI) for permission to conduct phase-3 trials in children up to a year old, as was done in phase 1 and 2 trials. However, the expert panel of DCGI said the company may conduct it for older individuals as well, minutes of its meeting showed. The plan is to develop an advanced version of JE vaccine that can cover a larger chunk of the population.
Japanese encephalitis is spread by Culex mosquitoes, with Odisha, Jharkhand, Chhattisgarh, Karnataka and Andhra Pradesh facing the brunt of the infections.
There are 68,000 cases reported globally per year.
The panel recommended revising the study for determining the population’s immunity to the infection by increasing the age group of test subjects to 65 years and above, the minutes of the meeting showed.
Persons vaccinated in the last year for seasonal flu and Typhoid Conjugate Vaccine should be excluded from the study, the panel said. After this, Bharat Biotech should submit the revised phase III clinical trial protocol for further deliberations.
Queries sent to health ministry and Bharat Biotech remained unanswered.
Meanwhile, efficacy of JE vaccination in India is 86.7%, according to a study by ICMR-National Institute of Virology, Pune.
In China it was found to be 98% effective, according to World Health Organization.
The study holds great significance as despite government immunization drives, the disease persists among children in central India. The participants in the study were administered with China-made live-attenuated SA 14-14-2 vaccines.
Researchers conducted the study in 2018-2020 in Maharashtra and Telangana to estimate Japanese encephalitis vaccination effectiveness among children in the age group of 1-15 years. The government uses Chinese-made live-attenuated SA 14-14-2 vaccines.
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Updated: 01 Oct 2023, 10:44 PM IST
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