Cadila Pharmaceuticals Friday launched a three-dose recombinant nanoparticle-based rabies G protein vaccine in Ahmedabad.
Hailed as a “breakthrough” product by rabies experts, the three-dose regimen, to be administered over a span of a week (on day 0, day three, and day seven) after exposure to the virus, is a first in the long list of existing rabies vaccines that require five doses. The three-dose regimen is expected to cost a patient Rs 2,145 and is expected to be launched in the private market across 11 states, including Gujarat, on April 18.
Dr. Manjul Joshipura, senior vice-president of Innovations and New Products at Cadila Pharma, said the vaccine has been in development since 2010. After introducing it in the private sector, the company may consider approaching the government as well to add it to the basket of rabies vaccine at government facilities, but subject to pricing negotiations with the government, he added.
The result of the phase-3 clinical trial of the vaccine involving 800 volunteers aged between 18 to 65 years was published in September 2021 in Human Vaccines and Immunotherapeutics journal.
Based on existing studies and literature, nearly 30-40 percent of patients drop out after three doses of the existing five-dose regimen owing to the complicated dosing schedule, frequent visits to the hospital or clinic, and potential loss of income associated with these visits, said Dr. Ravish HS of the department of Community Medicine, Kempegowda Institute of Medical Science, Bengaluru, and the lead author of the phase-3 trials. Hence, he said, the three-dose regimen of ThRabis will address this issue.
As rabies is not a notifiable disease, there is a lack of pan-India data on the incidence of animal bites and rabies, Association for the Prevention and Control of Rabies in India (APCRI) founder president Dr MK Sudarshan told The Indian Express. As per surveys conducted by APCRI, the total number of animal bites recorded in seven states — Himachal Pradesh, Bihar, West Bengal, Manipur, Kerala, Madhya Pradesh, Gujarat — rose from 998,276 in 2012 to 1,17,873 in 2016.
Cadila Pharmaceuticals stated that the vaccine is a step toward achieving the Union Health Ministry’s goal of the “National Action Plan for dog-Mediated Rabies Elimination (NAPRE) by 2030” launched in October 2021.
Terming the ThRabis vaccine as a “breakthrough”, Dr. Sudarshan suggested that the company must conduct a “post-market surveillance” to explore the success of the vaccine in the pediatric population and conduct studies with respect to special groups such as pregnant women and immunosuppressed persons.