E-Paper
J&J to seek nod for its one-shot vaccine’s trial
Johnson and Johnson's (J&J’s) vaccine can be given as a single-dose inoculation and is being seen as a crucial tool around the world in accelerating immunisations, particularly for a large country like India where only two candidates have been approved till now.
Johnson and Johnson (J&J) is set to seek permission to begin a phase 1/2 clinical trial of its coronavirus vaccine in India, the company said on Friday, announcing that it has begun discussions with authorities for the requisite approvals.
J&J’s vaccine can be given as a single-dose inoculation and is being seen as a crucial tool around the world in accelerating immunisations, particularly for a large country like India where only two candidates have been approved till now.
“At Johnson & Johnson, we remain fully focused on bringing a safe and effective Covid-19 vaccine to people around the world, if authorised for use by local health authorities. We are in discussions with the Government of India with the objective of starting a bridging clinical study of our Janssen Covid-19 vaccine candidate in India, subject to local regulatory approvals,” the company said in a statement.
The dose was developed by J&J’s subsidiary, Belgium-headquartered Janssen pharmaceuticals.
The product is also at the centre of an ambitious new vaccine partnership unveiled at the first Quad Summit between US, India, Australia and Japan for the manufacture and distribution of a billion doses to countries in Southeast Asia, the Indian Ocean and the Pacific Islands.
The US development bank will assist India’s Biological E to produce one billion doses of the J&J vaccine by the end of 2022, while Australia will help overcome last mile and logistical delivery issues.
The countries, following their summit on March 12, also agreed on collaborating on the necessary approval processes in different countries and with the World Health Organization.
In India, J&J’s application will be filed with the Central Drugs Standard Control Organisation (CDSCO), which requires products developed and tested outside of India to undergo a smaller bridging trial in the country.
The bridging studies are done in smaller numbers compared to full clinical trials, as long as there is adequate data on safety and efficacy for large studies in other countries.
Serum Institute of India (SII) performed bridging studies for the Oxford-AstraZeneca vaccine (used as Covishield) and has recently begun similar studies for the Novavax vaccine. Dr Reddy’s too is carrying out a bridging trial for the Sputnik V vaccine.
The dose, which uses a similar method as the Oxford-AstraZeneca vaccine (used in India as Covishield), has been approved in the US, the European Union, South Africa, Thailand and several others.
EU regulators, however, on Friday said they were reviewing blood-related side effects of J&J’s vaccine.
