J&J withdraws 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
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.
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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, Bharati Biotech's Covaxin, Russian Gamaleya Institute's Sputnik V and Moderna's vaccine.
