Johnson & Johnson on Tuesday said it is in talks with the Indian government to explore ways to accelerate delivery of its single dose COVID-19 vaccine in the country. The company also said as per a recent announcement by the Indian drug regulator, there is no longer a need to conduct bridging clinical trials of COVID-19 vaccines in India.
“We are in ongoing discussions with the Government of India and are exploring how best to accelerate our ability to deliver the Johnson & Johnson single dose COVID-19 vaccine to the people of India," Johnson & Johnson India spokesperson said in a statement. As per the recent announcement by the Drugs Controller General of India (DCGI), there is no longer a requirement to conduct bridging clinical studies of COVID-19 vaccines in India, the statement added.
On June 2, DCGI had waived the requirement of testing every batch of foreign-made COVID-19 vaccines by the Central Drugs Laboratory, Kasauli and post-approval bridging trials for such firms if the vaccine batch/lot has been certified and released by National Control Laboratory of the country of origin. DCGI on Tuesday granted permission to Mumbai-based pharma major Cipla to import Moderna’s COVID-19 vaccine for restricted use in the country.
Moderna’s vaccine will be the fourth COVID-19 jab available in India after Covishield, Covaxin and Sputnik V.