Johnson & Johnson Says In Talks With Government Of India To Test Single Dose Vaccine | India News
BENGALURU: Johnson & Johnson is in talks with the Indian government to begin a clinical trial of its single-dose COVID-19 vaccine in the country, the company said on Friday.
The American drug and health giant’s vaccine is currently approved for use in the United States, the European Union, and other nations, including Thailand and South Africa.
The news comes as parts of India face a shortage of vaccine supplies just as the country of 1.3 billion battles a second wave of Covd-19 infections. However, the Indian government has said there is no shortage of injections.
One report said that J&J had sent a letter to India’s Central Medicines Standards Control Organization (CDSCO) saying that it would “very soon apply for permission to conduct bridging clinical trials in India.”
The CDSCO did not immediately respond to Reuters’ request for comment.
“We are in discussions with the (government) with the goal of initiating a bridging clinical trial of our Janssen Covid-19 vaccine candidate in India, subject to local regulatory approvals,” a local J&J representative said by email.
A bridge study assesses the safety and immunogenicity of a vaccine, and India has indicated that any vaccine manufacturer must conduct such a test for an injection to be considered for their immunization program.
Furthermore, J&J has an agreement with the Indian company Biological E Ltd to contract manufacture its vaccine.
India currently has two approved vaccines in use, one developed by the University of Oxford and AstraZeneca and the other, an injection from local gamer Bharat Biotech.
There are other candidate vaccines in trials in India, including Russia’s Sputnik-V and an injection developed by Cadila Healthcare Ltd.
Covid-19 infections in India rose by a record number for the third day in a row on Friday, increasing by more than 130,000, while daily deaths reached their highest level in five months.