Mumbai-based drug maker TechInvention Lifecare has launched an oral cholera vaccine in India, in partnership with South Korean Eubiologics, following its successful phase III clinical trial, the company announced on Thursday.
"Euvichol-Plus is the world's first and only oral cholera vaccine that comes in a low-density polyethylene (LDPE) unidose pack in India," the company said in a statement.
The LDPE unidose pack of Euvichol-Plus is not only easy and safe to use, but it also reduces the issues pertaining to conventional glass vials in terms of breakage, storage, transportation, distribution, waste management, and facilitates delivery in emergency situations and humanitarian crises in campaign mode.
Cholera remains a major global public health threat, and there has also been an alarming resurgence of cases in susceptible countries globally amidst the stoppage in production of one of the only two cholera vaccines.
The company has received "marketing authorisation by the Indian FDA after a stringent evaluation process" Syed Ahmed, TechInvention Founder and CEO, told IANS.
"The first vaccine for cholera in India was Shanchol being manufactured by Sanofi Pasteur, which stopped manufacturing recently. This makes Euvichol Plus the only WHO prequalified vaccine that's being consistently supplied to UN healthcare agencies and low and middle income countries all across.
"Given the situation, we will work with Eubiologics to enable consistent and adequate supplies in India in spite of the global shortages," he said.
Eubiologics has, to date, provided around 110 million doses of the Euvichol-Plus vaccine from 2018 to 2023 in around 32 countries through UNICEF.
India features at the top of the list of cholera-endemic countries, with an estimated incidence rate of 1.64 per 1,000 people. In India, estimates show that 400 million people are at risk of cholera, with an estimated 6,751,888 cases and 20,256 (3 per cent) deaths annually. From 2011 to 2020, 565 outbreaks were reported in India that led to 45,759 cases and 263 deaths.
"We wish to contribute to the national initiatives along the lines of WHO's 'Ending Cholera: A Global Roadmap by 2030'. TechInvention has two more vaccines in late-stage clinical development and regulatory approval in India, while there are more on the anvil," Ahmed said in the statement.
Ahmad told IANS that Euvichol-Plus "is a liquid formulation of oral cholera vaccine containing O1 and O139 of Vibrio cholerae inactivated by heat or formalin and fulfils WHO requirements for cholera vaccine. The bacterial cells are inactivated with either formalin or heat. Being bivalent inactivated the vaccine is safe and immunogenic".
The vaccine targets "all age groups of one year and above", he added.
The phase III, open-label, multicenter, parallel-group, randomised clinical study compared the immunogenicity and safety of Euvichol-Plus with Shanchol (Sanofi Pasteur) in healthy Indian adults and children and showed a positive result.
For the study, the company also collaborated with the ICMR-National Institute of Cholera and Enteric Diseases (ICMR-NCED), for the bioanalytical testing. Clinical trials have been conducted as per the ICH-GCP guidelines and clinical study report approved by the Indian FDA post the subject expert committee meeting, Ahmed said.
While the company did not disclose the price, it said that the discussion is ongoing "with the government and private procurement bodies" for "a price that is affordable and in the interest of public health".
"We are happy to have collaborated with TechInvention and to bring our WHO-prequalified cholera vaccine, Euvichol-Plus, in a unidose pack to India. We hope to make a difference in the lives of Indian children and contribute to the reduction of disease prevalence by increasing vaccine coverage wherever it is needed," said Eubiologics CEO Yeong-Ok Baik, in the statement. (PB/NewsGram)