'Withdrew application because...': Johnson & Johnson on accelerated approval of its Covid vaccine in India

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. A line in drug regulator's note recently said that the company withdrew its proposal without giving any details.
A box containing vials of Johnson & Johnson vaccine against Covid-19.(AFP File Photo)
A box containing vials of Johnson & Johnson vaccine against Covid-19.(AFP File Photo)
Published on Aug 02, 2021 03:31 PM IST
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Byhindustantimes.com | Written by Amit Chaturvedi, Hindustan Times, New Delhi

India's drug regulator said on Monday that Johnson & Johnson withdrew its proposal seeking accelerated approval of its Covid-19 vaccine in the country, without giving additional details.

"The firm has informed that they are withdrawing their proposal," a line in Central Drugs Standard Control Organisation's (CDSCO) note on a meeting held accelerated approval process said. The meeting was held on July 29.

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

As per the data available till July 31, Johnson & Johnson is yet to request a full approval for its shot with the US Food and Drug Administration (FDA), while Pfizer Inc, BioNTech SE, and Moderna Inc have already sought full approval of their vaccines with the FDA.

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.

Johnson & Johnson is in the eye of storm in the United States over a rare autoimmune disorder. About 100 preliminary reports of Guillain-Barré syndrome (GBS) have been detected in the United States after vaccination with J&J shot, mostly in men, many of whom were 50 or older.

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

Update: In an official response to the story, Johnson & Johnson said, "We remain committed committed to bringing our 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."

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Thursday, December 09, 2021