PremiumJohnson and Johnson is planning to conduct a bridging study of its single-dose covid-19 vaccine in India soon, a spokesperson for its Indian arm 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 spokesperson said, adding it is focused on bringing the vaccine to people around the world.
A bridging study involves human trials among the local population to determine the safety and immune response because vaccines often differ in safety and effectiveness among varying demographics.
A successful bridging study could lead to permission for its local use, lifting India’s vaccine production capacity at a time several states have complained of an acute vaccine shortage.
The Indian regulator has also stressed the importance of such studies and refused to give a waiver to Pfizer when it sought an import licence for its messenger RNA vaccine in India.
J&J already has an agreement with Hyderabad-based Biological E to manufacture around 1 billion doses of its vaccine for export.
However, Mint could not ascertain whether J&J will be applying for the trial in India through Biological E or will be doing the trial on its own. Spokespeople for both J&J and Biological E declined to comment on the matter.
J&J’s bridging study in India also assumed importance because only 3.5% of its more than 40,000 participants in the global trial conducted in the US, Brazil, South Africa and a few other countries, were Asians, and the company did not have accurate information of efficacy in the sub-group. 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%.
Premium Premium 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 issued an emergency use authorization for the vaccine, with J&J starting supplies from the end of March.
The company is already working on supplying 100 million doses of the vaccine to the US by the first half of 2021.
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