PremiumNEW DELHI: Johnson & Johnson plans to soon start a bridging study in India for its single-dose covid-19 vaccine, a spokesperson for its Indian arm said in a statement.
“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 spokesperson said, adding that it is focused on bringing the vaccine to people around the world.
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A bridging study involves conducting human trials to determine the safety and immune response of the vaccine among local population and is necessary because vaccines often differ in safety and effectiveness among varying demographics.
The Indian regulator has stressed on the importance of such studies and had refused to give a waiver to Pfizer when it sought an import license for its messenger RNA vaccine in India.
In India, J&J is in a pact with Hyderabad-based Biological E to manufacture around 1 billion doses of the single-dose vaccine.
Mint, however, could not ascertain if J&J will apply for the trial in India through Biological E, or conduct the trial alone. Spokesperson for both J&J and Biological E declined to comment on the matter.
Johnson & Johnson’s study of the vaccine’s effectiveness in Indian population is key because only 3.5% of its over 40,000 participants in global trial, conducted in US, Brazil, South Africa and a few other countries, were Asians, and the company did not have an accurate information of efficacy in the sub-group.
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Premium Premium The vaccine could be a critical tool in India’s fight against covid-19, just like it is now in the US, because it is a single-shot vaccine with an efficacy of 66.3%.
Several states in India, most prominently Maharashtra, are currently facing a shortage of vaccine amid high demand while Bharat Biotech International Ltd and Serum Institute of India are struggling to expand their capacity.
In February, the US Food and Drug Administration had issued an emergency use authorisation for the vaccine, with J&J starting supplies from the end of March.
The company is working on supplying 100 million doses of the vaccine to the US by the first half of 2021.
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