Mumbai: US company Johnson & Johnson (J & J) has been looking for emergency use authorization (EUA) for dose-19-dose vaccine in India.
After being approved, it would be the fourth villa to get EUA after the Serum Institute Covishield, Bharat Biotech’s Covaxin and Dr.
Reddy’s Sputnik V.
Earlier this week, the company said it had completed its plan, immediately after pulling its application to conduct local research.
Without describing the plan for making vaccines, J & J said that the collaboration with Hyderabad-based biology will be an important part of its global supply chain network.
The company has been tied with biological e years ago.
“It is a major milestone that paves the way to bring our single dose vaccine to India, and the whole world, through the collaboration with biological e limited,” said a spokesman J & J.
Submission EUA is based on the efficacy and data of the Topline Safety of Clinical Test Ensemble Phase 3, which indicates that the single-shot vaccine is 85% effective in preventing severe diseases in all regions studied, and show protection of inpatients regarding Covid-19 and death, after 28 days of vaccination, the company statement said.
J & J has resigned its application to the country’s drug regulator because there are no local bridging trial requirements, after a foreign-19-foreign vaccine tweaks are produced quickly.
Although the revised policy to facilitate the entry of import vaccines was announced in April, there has been no progress in the launch of any foreign-made vaccine, so far.
Talks with foreign companies – Pfizer, Moderna and Johnson & Johnson – have been going on for months but no decision by the government has not provided compensation for producers from lawsuits.