Johnson & Johnson is all set to begin India trial of its Single-Shot Vaccine Soon
US pharma giant Johnson & Johnson, the only manufacturer with a single-dose Covid-19 vaccine, has communicated to the Indian regulator that it will soon begin traversing clinical trials in the country.
US pharma giant Johnson & Johnson, the only manufacturer with a single-dose Covid-19 vaccine, has communicated to the Indian regulator that it will soon begin traversing clinical trials in the country.
According to the top government sources, J&J will soon conduct the trials, which could asphalt the way for its vaccine to be marketed in India. As per the statement, “Johnson & Johnson has sent a letter to the CDSCO (Central Drugs Standard Control Organisation) that they will very shortly apply for permission to conduct clinical bridging trials in India.”
A bridging trial is a clinical trial where the regulator will ask the firm to enrol a small group (around 1,000 participants) to only establish the safety and immunogenicity of a vaccine. As per the top government sources, the bridging trial will be similar to the trial being conducted by Dr Reddy’s for Russian Vaccine Sputnik V and the one done by the Serum Institute of India for the AstraZeneca-Oxford vaccine.In India, J&J has tied up with Biological E to expand production capabilities of its vaccine candidate.
