J&J awaiting DCGI nod for bridging trial of one-dose jab

USA drug maker Johnson & Johnson is waiting for approval from the drug controller of India to start its bridging trials for its one-dose vaccine to comply with local regulations in India.

The drug maker also said that it is working with India’s Biological E on manufacturing its Covid-19 vaccine as part of a global arrangement to supply vaccines around the world.

“In line with this commitment, we have submitted an application to the Drugs Controller General of India (DCGI) requesting approval to conduct a bridging clinical study of our single-dose Janssen Covid-19 vaccine candidate in India to comply with local regulations,” J&J said in an emailed statement to ET.

It is unclear why J&J wants to conduct a bridging trial in India despite regulations in India allowing easy access to vaccines that have received either a USFDA or EU approval. Companies can import vaccines with such regulatory clearances without doing a bridging trial.

VK Paul, chairman of India’s National Expert Group on Vaccine Administration Committee (NEGVAC), on Thursday, said that international vaccine makers such as J&J are welcome to apply for import licence and the government will issue an approval in two days.

In August last year J&J had announced that it will be tying up with Hyderabad-based Biological E to launch its one-dose Covid-19 vaccine in India. However, since that announcement neither Biological E nor J&J have given much indication on how the tieup is progressing and when the vaccine will be available in India.

Company officials aware of the development told ET that Biological E may have prioritised its own vaccine candidate development over J&J vaccine. The supply commitments of J&J to countries that have made advance purchase commitments may have also put India at the back of the queue.