Before rolling out vaccines in India, foreign vaccine makers must conduct at least a Phase-three trial with Indian volunteers even if the vaccine is approved outside India.
According to a report in an Indian newspaper, Tata Group’s health care venture is said to have begun initial discussions with American biotechnology company Moderna Inc for a partnership to launch its Covid-19 vaccine in India.
The Economic Times reported that officials with knowledge of the matter stated that Tata Medical & Diagnostics may team up with India’s premier research organization Council of Scientific & Industrial Research to run clinical trials of Moderna’s vaccine candidate in India.
Indian government’s norms require foreign vaccine makers to conduct at least a Phase-three trial with Indian volunteers even if the vaccine is approved outside India, before rolling out their vaccines in the country.
As per data released in November from Moderna’s late-stage study indicated that its Covid-19 vaccine was 94.1% effective with no serious safety concerns. Earlier this month, the United States and Europe approved Moderna shots for use. On Monday, Moderna claimed that its Covid-19 vaccine retains neutralizing activity and remains protective against the new strain of coronavirus first identified in the United Kingdom and South Africa.
In November, Tata Group had launched a Covid-19 test kit that gives results in under an hour and is claimed to be as precise as the RT-PCR method.
As we have reported earlier, India’s drug regulators approved two vaccines for emergency use – Covaxin manufactured by Bharat Biotech and Oxford University and AstraZeneca vaccine Covishield produced by the Pune-based Serum Institute of India.