Johnson & Johnson (J&J) has requested permission to conduct Phase 3 clinical trials of its unique Covid-19 vaccine in India.
J&J has requested permission to conduct phase 3 studies for its one-of-a-kind Covid vaccine in India (Photo by Reuters).
Pharmaceutical multinational Johnson & Johnson (J&J) has requested permission to conduct Phase 3 clinical trials of its unique Covid-19 vaccine in India. J&K on Monday applied to the Indian Medicines Agency to request a nod to conduct Phase 3 studies as well as an import license.
Sources told PTI the company requested an early meeting of the Central Drugs Standard Control Organization’s (CDSCO) Committee of Experts on Covid-19 to make a decision on its application.
The development comes close to the central government’s decision to speed up emergency clearances for all overseas-made coronavirus puffs that have received a similar nod from the World Health Organization (WHO) or regulators in the US, Europe and the UK, or Japan against the backdrop rising Covid-19 cases in the country and the lack of vaccines.
Such vaccines will receive an emergency approval that will require a parallel post-approval bridging study instead of conducting local clinical trials under the terms of the New Drugs and Clinical Trials Rules 2019, according to the Department of Health.
Sources said Johnson & Johnson applied to the Global Clinical Trial Division through the Sugam online portal on April 12, instead of applying to the biological department, which deals with vaccines and other biological products. Due to the technical issues, J&J resubmitted its application on Monday, a source said.
Unlike other vaccines, the Johnson & Johnson vaccine is a single dose vaccine that can be stored for up to three months at a temperature between 2 and 8 degrees Celsius. The vaccines that India has allowed to be administered among its citizens are double doses.
So far, three vaccines – the Oxford / Astrazeneca vaccine Covidshield, made by the Serum Institute in India, and the Covaxin vaccine developed by Bharat Biotech – have been administered in India, while the Russian vaccine Sputnik V has also been approved by the Indian Medicines Agency.
The government decided on Monday to expand its vaccination campaign to include all over 18s from May 1, and to allow state governments, private hospitals and industrial companies to source the doses directly from manufacturers.
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