US pharma giant Johnson & Johnson is reportedly in talks with the Indian government to begin a clinical trial of its single-shot COVID-19 vaccine. This news comes at a critical juncture in India’s fight against a rising tide of COVID cases nationwide.
Johnson & Johnson met with the Drugs Controller General of India (DCGI) to get approval for holding clinical trials in the country. The one-shot COVID vaccine developed by the healthcare company is currently adopted in the United States, the European Union and others including South Africa and Thailand.
A spokesperson for the Indian department of the company said, “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 DCGI has always stressed on the importance of bridging studies and had even refused Pfizer import licence for its messenger RNA vaccine.
Johnson & Johnson has also roped in Hyderabad-based Biological E as a manufacturer for its single-shot vaccines.
The vaccine could be a critical tool in India’s arsenal due to its proven track record in the US with a success rate of 66.3%.
The Indian government has currently approved two vaccines to be used for vaccination drives – the AstraZeneca-Oxford vaccine and a domestic variant from Bharat Biotech.
As several states in India are struggling to get their citizens vaccinated amidst growing concerns of vaccine shortage, the latest announcement by Johnson & Johnson should calm frayed nerves.
Top government sources confirmed the news in a statement saying, “Johnson & Johnson has sent a letter to the CDSCO (Central Drugs Standard Control Organisation) that they will very shortly apply for permission to conduct clinical bridging trials in India.”
A successful trial could see the vaccines being marketed in India which will relieve the burden on Serum Institute of India and Bharat Biotech, which are already struggling to increase production capacities.