Johnson & Johnson withdraws proposal for speedy COVID vaccine approval in India
India had, in May, scrapped local trials for "well-established" foreign coronavirus vaccines as it tried to hasten vaccination rollouts to fight a second wave of infections.
FollowIndia's drug regulator, CDSCO, on Monday said Johnson & Johnson has withdrawn its proposal seeking accelerated approval of its Covid-19 vaccine.
"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.
Johnson & Johnson said on Monday it was still in talks with the Indian government over its Covid-19 vaccine after the country's drug regulator announced the company had pulled its proposal seeking an accelerated approval for local trials.
India had, in May, scrapped local trials for "well-established" foreign coronavirus vaccines as it tried to hasten vaccination rollouts to fight a second wave of infections.
"We are in ongoing discussions with the Government of India and are exploring how best to accelerate our ability to deliver our Covid-19 vaccine to India," Johnson & Johnson said in an emailed statement.
The US-based company had said in April it was seeking 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, last at least eight months. The healthcare company added that its vaccine was 85% effective and could also help prevent hospitalisation and death.
As of July 28, only 10% of India's adult population of about 944 million people had been inoculated with both doses, with 47% receiving at least one shot.
India has so far approved four vaccines - AstraZeneca's Covishield, Bharati Biotech's Covaxin, Russian Gamaleya Institute's Sputnik V and Moderna's vaccine.
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