Johnson & Johnson says talks with India on Covid vaccine Janssen still going on

Central Drugs Standard Control Organisation had earlier said in a note that Johnson & Johnson "has informed that they are withdrawing their proposal". But the US-based company said the discussions about Janssen are still on.
A health worker prepares a dose of Janssen Johnson & Johnson Covid-19 vaccine at Leopold Sedar Senghor stadium in Dakar, Senegal.(AP Photo)
A health worker prepares a dose of Janssen Johnson & Johnson Covid-19 vaccine at Leopold Sedar Senghor stadium in Dakar, Senegal.(AP Photo)
Published on Aug 02, 2021 06:08 PM IST
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By hindustantimes.com | Written by Amit Chaturvedi, Hindustan Times, New Delhi

Days after India's drugs regulator announced that Johnson & Johnson has pulled out its proposal seeking accelerated approval of its Covid-19 vaccine, the company said that the talks are still on.

“Johnson & Johnson remains committed to bringing its single-dose Covid-19 vaccine to the people of India. 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," an official statement from the American pharmaceutical firm read.

Without giving any details, Central Drugs Standard Control Organisation's (CDSCO) had said in a note that the US-based company "has informed that they are withdrawing their proposal" seeking accelerated approval of its Covid-19 vaccine. There is no response from CDSCO to Johnson and Johnson's statement.

Johnson & Johnson had said in April it was seeking an approval to conduct a bridging clinical study of its Janssen Covid-19 vaccine candidate in India.

In May, India scrapped local trials for foreign coronavirus vaccines, which have been cleared by drug regulators in countries like the US, in a bid to hasten vaccination rollouts to fight a second wave of infections.

Till July 31, Johnson & Johnson has not requested a full approval for its shot with the US Food and Drug Administration (FDA), while Pfizer Inc, BioNTech SE, and Moderna Inc have already done so.

The Indian government, meanwhile, has formed a team 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, Minister of State in Union health ministry, said last week.

Johnson & Johnson has claimed that their vaccine generates a strong and persistent response activity against Delta and other prevalent strains of coronavirus. The neutralising antibodies, according to the company, lasts at least eight months. The healthcare company added that its vaccine was 85 per cent effective and could also help prevent hospitalisation and death.

India has so far approved four vaccines - AstraZeneca's Covishield, Bharat Biotech's Covaxin, Russian Gamaleya Institute's Sputnik V and Moderna's vaccine.

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Saturday, October 23, 2021