The two-dose inactivated virus vaccine for pediatric, adolescent and adult use, that took eight years to develop as the company lost a few years due to Covid-19, was rolled out here on Friday. Each dose of the vaccine will be priced at Rs 2,150, IIL managing director Dr K Anand Kumar told TOI.
“Currently Hepatitis-A vaccines are imported into the country and the launch of Havisure is a testament to our committment to advancing healthcare solutions for the nation and Atmanirbhar Bharat. The vaccine has undergone extensive clinical trials in eight centres and proven to be safe and efficacious,” the IIL MD said.
The intramuscular injectable vaccine, which has to be administered at a gap of six months, was tested on over 500 volunteers, including babies as young as 12 months old, adolescents and adults of up to 49 years of age, in Phase II/III human clinical trials conducted at centres in cities such as Hyderabad, Mysuru, Pune, Chandigarh, Vizag and Kolkata, he said.
IIL also conducted a randomised phase-II/III non-inferiority study to test it against the leading global Hepatitis-A vaccine sold by a multinational company. Both the studies have already been published in vaccine journals.
While the vaccine trials were wrapped up in early 2022, it received approval from the Drugs Controller General of India in September last year.
The company has put in place an annual capacity of 1 million doses for Havisure at its Gachibowli human vaccines manufacturing facility in Hyderabad, he said.
As per estimates over 100 million people are affected globally by Hepatitis-A with about 30,000 people dying each year due to the viral infection.
Havisure is the third vaccine to be rolled out by IIL, a wholly-owned subsidiary of National Dairy Development Board (NDDB), in a year’s time after measles and rubella (MR) vaccine Mebella in Nov 2023 and tetanus and diptheria (TD) vaccine TeddyVac in Aug 2023.