‘Still in Talks With Indian Govt’, Says J&J Regarding COVID Vaccine Approval
As of 31 July, Johnson and Johnson is yet to request a full approval for its shot with the United States FDA.
United States (US) based pharmaceutical company Johnson & Johnson said on Monday, 2 August, that it was still in talks with the Indian government over its COVID-19 vaccine, Janssen, after India's drug regulator Central Drugs Standard Control Organisation (CDSCO) announced that J&J had withdrawn its proposal seeking accelerated approval for local trials, news agency Reuters reported.
Moreover, in May, India had scrapped local trials for 'well-established' foreign coronavirus vaccines in order to hasten vaccination rollouts to fight a second wave of infections.
The supposed proposal withdrawal comes while India tackles legal challenges with manufacturers over indemnity issues. Union Minister of State for Health and Family Welfare Bharati Pravin Pawar was quoted by Reuters as saying:
"This team is in continuous dialogue with Pfizer, Moderna and Johnson and Johnson to discuss and address various issues including the issue of indemnity."
Previously, in April, Johnson and Johnson had said that it was seeking an approval to conduct a bridging clinical study of it's COVID-19 vaccine candidate in India. During that period, however, trials were paused in the United States over reports of rare blood clots.
According to Reuters, as of 31 July, Johnson and Johnson is yet to request a full approval for its shot with the United States FDA.
As of 28 July, around 10 percent of India's adult population had been inoculated with both doses, with 47 percent having received at least one jab.
(With inputs from Reuters)
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