U.S.-based pharmaceutical company Johnson & Johnson has said the requirement to conduct a bridging clinical study of its single-dose Janssen COVID-19 vaccine candidate no longer exists in India.
The company said it was following Drug Controller General of India’s recent announcement that there was no longer any requirement for conducting post-approval bridging clinical trials for COVID-19 vaccines in India for restricted use in emergency situation in case of those already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan, listed in WHO Emergency Use Listing (EUL) or are well-established ones from the standpoint that millions of individuals have already been vaccinated.
“At Johnson & Johnson, we remain fully focussed on bringing a safe and effective COVID-19 vaccine to people in India. We are in ongoing discussions with the Government of India and are exploring how best to accelerate our ability to deliver our COVID-19 vaccine to India,” the company noted.
