US pharma giant Johnson & Johnson is in talks with the Indian government to start clinical trials of its single-dose COVID-19 vaccine in the country, the company said on Friday.
The J&J vaccine has been approved for use in the United States, the European Union and other nations including Thailand and South Africa. The norms in India also require such companies to carry out local trials to prove their safety and efficacy of their vaccines before they can be approved for use.
Currently there are other vaccine candidates undergoing trials in India including Russia's Sputnik V and a shot developed by indigenous pharma major Cadila Healthcare Ltd.
According to sources, the J&J has sent a letter to India's Central Drugs Standard Control Organisation (CDSCO) in order to seek permission for initiating the process for vaccine trials.
"We are in discussions with the government with the objective of starting a bridging clinical study of our Janssen COVID-19 vaccine candidate in India, subject to local regulatory approvals," a local J&J representative said.
J&J has a deal with Indian firm Biological E Ltd to contract-manufacture its vaccine. In the recent Indo-Pacific Quad summit attended by the US, India, Japan and Australia it was one of the vaccines, apart from Novavax, identified for manufacturing in India to meet the acute shortage of shots worldwide.
India presently has two approved vaccines in use, one developed by Oxford University and AstraZeneca that is being produced by the Serum Institute of India and the other, a homegrown shot developed by the Indian Council of Medical Research and Hyderabad-based private company Bharat Biotech.
Meanwhile COVID-19 infections in India rose by a record number for a third straight day on Friday, increasing by more than 130,000, while daily deaths hit their highest in five months. Just five states account for 73% of the total number of coronavirus cases in the country. Maharashatra tops the list with over 50% of the total infections.
The vaccination drive in the country has now covered more than 9.3 crore people, with over 36 lakh doses being administered in the last 24 hours.
