Hyderabad: Biopharma major Indian Immunologicals Limited has developed India’s first indigenous Hepatitis A vaccine , Havisure – To protect against highly contagious liver infections that spread through ingestion contaminated food Or water.
two-dose inactivated virus vaccine hair therapy, teen and adult use, which took eight years to develop as the company lost a few years due to Covid-19, was launched here on Friday. IIL managing director Dr K Anand Kumar told TOI that each dose of the vaccine will cost Rs 2,150.
“Currently Hepatitis-A vaccines are imported into the country and the launch of Havisure is a testament to our commitment to advance healthcare solutions for the nation and a self-reliant India. The vaccine has undergone extensive clinical trials in eight centers and has proven to be safe and efficacious,” said the IIL MD.
The intramuscular injectable vaccine, which is to be administered at an interval of six months, was tested in more than 500 volunteers, including children from 12 months, adolescents and adults up to 49 years of age, in Phase II/III. Clinical trials were conducted at centers in cities like Hyderabad, Mysore, Pune, Chandigarh, Vizag and Kolkata, he said.
IIL also conducted a randomized phase-II/III non-inferiority study to test it against the leading global hepatitis-A vaccine sold by a multinational company. Both studies have already been published in vaccine journals.
While testing of the vaccine was completed in early 2022, it received approval from the Drug Controller General of India in September last year.
The company has set up an annual capacity of 1 million doses for Havisure at its Gachibowli human vaccine manufacturing facility in Hyderabad, he said.
It is estimated that more than 100 million people are affected by hepatitis A globally and approximately 30,000 people die every year due to the viral infection.
Havisure is the third vaccine to be launched by IIL, a wholly owned subsidiary of National Dairy Development Board (NDDB), within a year after Measles and Rubella (MR) vaccine Mabela and Tetanus and Diphtheria (Td) vaccine in November 2023. Teddyvac in August 2023.
two-dose inactivated virus vaccine hair therapy, teen and adult use, which took eight years to develop as the company lost a few years due to Covid-19, was launched here on Friday. IIL managing director Dr K Anand Kumar told TOI that each dose of the vaccine will cost Rs 2,150.
“Currently Hepatitis-A vaccines are imported into the country and the launch of Havisure is a testament to our commitment to advance healthcare solutions for the nation and a self-reliant India. The vaccine has undergone extensive clinical trials in eight centers and has proven to be safe and efficacious,” said the IIL MD.
The intramuscular injectable vaccine, which is to be administered at an interval of six months, was tested in more than 500 volunteers, including children from 12 months, adolescents and adults up to 49 years of age, in Phase II/III. Clinical trials were conducted at centers in cities like Hyderabad, Mysore, Pune, Chandigarh, Vizag and Kolkata, he said.
IIL also conducted a randomized phase-II/III non-inferiority study to test it against the leading global hepatitis-A vaccine sold by a multinational company. Both studies have already been published in vaccine journals.
While testing of the vaccine was completed in early 2022, it received approval from the Drug Controller General of India in September last year.
The company has set up an annual capacity of 1 million doses for Havisure at its Gachibowli human vaccine manufacturing facility in Hyderabad, he said.
It is estimated that more than 100 million people are affected by hepatitis A globally and approximately 30,000 people die every year due to the viral infection.
Havisure is the third vaccine to be launched by IIL, a wholly owned subsidiary of National Dairy Development Board (NDDB), within a year after Measles and Rubella (MR) vaccine Mabela and Tetanus and Diphtheria (Td) vaccine in November 2023. Teddyvac in August 2023.