Johnson & Johnson is in talks with the Indian government to bring its one-dose vaccine directly, following the revised norms that do not require bridging trials.
“Since the Drugs Controller General of India (DCGI) recently directed that there is no longer a requirement to conduct bridging clinical studies of Covid-19 vaccines in India, Johnson & Johnson withdrew its application to conduct these studies. We look forward to ongoing discussions with the Government of India and will continue to explore how to accelerate availability of the Johnson & Johnson Covid-19 vaccine in India,” a company spokesperson clarified, following reports that the company had withdrawn its application.
The American company will now look to import the vaccine, even as it has a manufacturing tie-up in India with Biological E. All eyes have been on the government recently, with foreign companies such as Pfizer raising the issue of indemnity to be granted before they bring in their vaccines. The Centre has indicated that it was in talks with companies, including Pfizer, Moderna and J&J, on the issue.
The single-dose vaccine received emergency-use authorisation in the US in late February, with the WHO following close on its heels and giving similar approvals in mid-March.