Johnson & Johnson withdraws proposal for speedy COVID-19 vaccine approval in India: DCGI
New Delhi | Jagran News Desk: The Central Drugs Standard Control Organisation (DCGI) on Monday said that American multinational Medical device company Johnson & Johnson has withdrawn its Covid-19 vaccine proposal from India seeking accelerated approval for local trials.
The company had sought approval in April to conduct a bridging clinical study of its Janssen Covid-19 vaccine candidate in India. There were even reports that a few thousand doses of Johnson & Johnson's vaccine could arrive in India in July.
In February, the US FDA also approved Johnson & Johnson's viral vector Covid-19 vaccine for emergency use in the country. However, later the vaccine was linked to a rare but serious blood-clotting disorder. As a result, trials in the United States at that time were paused.
The withdrawal comes as India is mulling legal challenges with manufacturers over indemnity issues. Last week, the junior health minister has said that a team has been made to engage with vaccine makers.
"This team is in continuous dialogue with Pfizer, Moderna and Johnson & Johnson to discuss and address various issues including the issue of indemnity," Bharati Pravin Pawar had said.
As of now, nothing has been made clear as to why Johnson & Johnson has withdrawn its proposal from India. The Central Drugs Standard Control Organisation (CDSCO) did not immediately respond to the International news agency Reuters' requests for comment over the matter.
Other the other hand Johnson & Johnson said in an emailed statement to Reuters "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."
Johnson & Johnson has the efficacy of 66.3 per cent for mild to moderate Covid-19 and 76.3 per cent for severe to critical infection according to the World Health Organization (WHO). However, it provides 100 per cent protection from hospitalisation for Covid-19 28 days after vaccination. Currently, four vaccines have received Emergency Use Authorisation (EUA) in India - AstraZeneca's Covishield, Covaxin, Sputnik V and Moderna.
(With inputs from agencies)
Posted By: Sugandha Jha