India’s drug regulator stated that Johnson & Johnson withdrew its proposal seeking accelerated approval of its Covid-19 vaccine in the country. They did not give any additional details.
“The firm has informed that they are withdrawing their proposal,” a line in Central Drugs Standard Control Organisation’s (CDSCO) noted in a meeting held accelerated approval process said. The meeting was held on July 29.
The company has informed that in April it was seeking approval to conduct a bridging clinical study of its Janssen Covid-19 vaccine candidate in India. Sources said that Johnson & Johnson is yet to request 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.
The company has also 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.
Till now India has approved four vaccines AstraZeneca’s Covishield, Bharati Biotech’s Covaxin, Russian Gamaleya Institute’s Sputnik V and Moderna’s vaccine.
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