Johnson & Johnson on Tuesday stated it is in negotiation with the Indian government to search ways to speed up delivery of its single dose COVID-19 antibody in the nation. The company also said as per a recent declaration by the Indian drug regulator, it is no longer necessary to perform bridging clinical tests of COVID-19 vaccines in India.
“We are processing negotiations with the Government of India and are exploring how best to speed up our ability to deliver the Johnson & Johnson single dose COVID-19 vaccine to the Indians,” Johnson & Johnson India representative said in a statement. According to the recent announcement by the Drugs Controller General of India (DCGI), it is not necessary to conduct bridging clinical studies of COVID-19 vaccines in India, the statement added.
On June 2, DCGI had relinquished the requirement of testing every batch of foreign-made COVID-19 antibodies by the Central Drugs Laboratory, Kasauli and post-approval bridging tests for such firms if the vaccine batch/lot has been certified and issued by National Control Laboratory of the country of origin. DCGI on Tuesday gave permission to Mumbai-based pharma major Cipla to import Moderna’s COVID-19 vaccine for limited use in the country.
Moderna’s antibody will be the fourth COVID-19 jab accessible in India after Covishield, Covaxin and Sputnik V.