Confusion continues around J&J local trials

Johnson and Johnson has approached India’s drug regulatory authority seeking an approval to undertake local trials for its single-shot Covid-19 vaccine, two people aware of the development told ET.The subject expert committee (SEC) of Central Drugs Standards Control Organisation, which advises the drug regulator on applications seeking approval for vaccines, new drugs and clinical trials, will soon take up the US pharma major’s application, they said. Johnson and Johnson (J&J), however, denied any plans to conduct local trials as India has relaxed regulatory requirements for imported vaccines, and said it’s in talks with the government to bring its vaccine to the country. J&J had in April approached the regulatory body seeking permission to conduct a bridging trial. The regulatory body had then sought some additional information such as complete details of the product, clinical evidence and documents related to the efficacy and safety of the vaccine, as reported by ET on June 17. J&J has furnished the information now, the sources cited earlier said. “The company never withdrew their application and now have sent their additional information which was sought then. They want to conduct a bridging trial,” one of them said. J&J, though, maintains what it had said on June 28, pointing out that the Drugs Controller General of India has done away with the requirement for conducting post-approval bridging clinical trials for Covid-19 vaccines already approved for restricted use by drug regulators of the US, Europe, the UK, or Japan, or which are listed by the WHO. “Thus, the requirement for Johnson & Johnson to conduct a bridging clinical study of our single-dose Janssen Covid-19 vaccine candidate no longer exists,” it had said.

from Economic Times https://ift.tt/2TpTVml