MRP set at ₹2,150 per shot for the two-dose Havisure that has been launched after years of R&D, extensive clinical trials as well as a non-inferiority study, says MD K Anand Kumar.
Vaccine maker Indian Immunologicals (IIL) on Friday launched the country’s first indigenously developed Hepatitis A vaccine.
The vaccine ‘Havisure’ represents a significant step forward in India’s fight against Hepatitis A and is poised to make a substantial contribution to public health, the National Dairy Development Board (NDDB) subsidiary said in a release on the launch in Hyderabad.
Currently, Hepatitis A vaccines are imported by India. IIL’s vaccine, which comes after eight years of work, is a true meaning of Atma Nirbhar Bharat, managing director K. Anand Kumar said. It was being rolled out following extensive studies ranging from pre-clinical toxicology studies in animals, phase I trial in human beings to phase 2/3 trials in eight centres involving nearly 500 healthy volunteers across various age groups. “We also did a non-inferiority study [comparing it with] GSK vaccine in which our vaccine was found very comparable,” he told The Hindu.
Havisure will be manufactured at IIL’s Gachibowli plant in Hyderabad. “Domestic market is our focus initially… self-sufficiency of the country is important, plan to make 1 million doses a year,” he said, while declining to share the development costs. There is scope to add more capacity, he added.
Exports
“We have our distribution network in India and also export vaccines to 50 countries… will also be exporting [the Hepatitis A vaccine],” Mr Kumar said, adding IIL will be seeking WHO pre-qualification for Havisure since that would give access to many markets abroad.
MRP of the vaccine has been set at ₹2,150 per dose. It is a two-dose vaccine — first dose administered at above 12 months of age and the second at least six months after the first dose. IIL said the vaccine is recommended for children as part of the routine immunization as well as for individuals at risk of exposure or travel to the regions with high hepatitis A prevalence. In addition to this people with occupational risk of infection and suffering from chronic liver diseases also require Hepatitis A vaccination.
A highly contagious viral infection, Hepatitis A primarily spreads through the fecal-oral route, meaning it is transmitted through the ingestion of contaminated food or water. Havisure is the third vaccine launched by IIL in a single year, which Mr.Kumar termed as an achievement giving credit to the team. The measles and rubella vaccine as well as TD vaccine are the other two.
source/contents: thehindu.com (headline edited)