New Delhi: Johnson & Johnson withdrew its proposal seeking accelerated approval of its Covid-19 vaccine in India on Monday, without providing further details. ‘The firm has informed that they are withdrawing their proposal,’ the Central Drugs Standard Control Organization (CDSCO) stated in a note on its accelerated approval process session. The meeting took place on July 29.
In April, the US-based company had said it was seeking approval to conduct a bridging clinical study in India to test its Janssen Covid-19 vaccine candidate. As of July 31, Johnson & Johnson has yet to submit a full application to the US Food and Drug Administration (FDA) for its shot, while Pfizer Inc, BioNTech SE, and Moderna Inc have applied for full FDA approval of their vaccines.
Johnson & Johnson claims that its vaccine generates a strong and persistent response against Delta and other prevalent coronavirus strains. It was noted that neutralizing antibodies can last up to eight months. According to the healthcare company, its vaccine is 85 percent effective and can also prevent hospitalization and death.
A rare autoimmune disorder has caused a storm for Johnson & Johnson in the United States. Approximately 100 preliminary reports of Guillain-Barré syndrome (GBS) have been detected in the United States after vaccination with the J&J shot, mostly among men 50 or older.
Currently, India has approved four vaccines – Covishield from AstraZeneca, Covaxin from Bharat Biotech, Sputnik V from the Russian Gamaleya Institute and Moderna’s vaccine.