Johnson & Johnson on Tuesday said it has sought approval from India’s drug regulator to begin a clinical trial of its coronavirus vaccine in the country, PTI reported. The vaccine, known as Janssen, is administered in a single-dose, and can be stored at refrigerator temperature.
“...We have submitted an application to the Drugs Controller General of India (DCGI) requesting approval to conduct a bridging clinical study of our single-dose Janssen COVID-19 vaccine candidate in India to comply with local regulations,” Johnson and Johnson said.
A bridging study tests the safety and immunogenicity of a vaccine, and India has indicated that any vaccine maker must conduct such a trial for a shot to be considered for its immunisation programme.
Johnson & Johnson’s request to Indian authorities came days after the central government decided to fast-track emergency approvals for all foreign vaccines that have been given a similar nod by the World Health Organization or regulators in the United States, Europe, Britain or Japan.
The news also comes as several states of India face a shortage of vaccine supplies as the country battles a second wave of coronavirus infections. The Centre, however, has said there is no shortage of shots.
So far, two vaccines – one developed by Oxford University and AstraZeneca and the other developed by Bharat Biotech – are being used in India. Both the vaccines are being manufactured within the country by domestic firms. While the Oxford/Astrazeneca vaccine, locally known as Covishield, is being manufactured by Serum Institute of India, the indigenously developed Covaxin is being manufactured by Bharat Biotech.
A third vaccine Sputnik V – developed in Russia and to be imported and sold in India by Dr Reddy’s Laboratories – has also been approved by the Indian drug regulator.
The government, meanwhile, on Monday decided to expand its vaccination drive by allowing everyone above 18 years of age to get vaccines from May 1. The Centre also permitted state governments, private hospitals and industrial establishments to procure doses directly from manufacturers.