Covaxin was given to a 30 year old Delhi based man, till now no side effect has been reported but the man is under close monitoring. Few More participants were given the vaccine on saturday.
Pune’s Serum Institute of India has asked for permissions from Drugs Controller General of India for conducting phase 2/3 human clinical trials of the potential vaccine covaxin.
The Pune Firm aims to produce Covaxin next year on mass scale. This vaccine will be priced below Rs 1,000.
According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and harms of ‘Covishield’ in healthy Adults.
Initial results of the first 2-phase trials of the vaccine conducted in 5 trial sites in the United Kingdoms showed it has an acceptable safety profile and homologous boosting increased antibody responses.
To introduce the vaccine, the Pune firm has signed an agreement, deal to manufacture the potential covid-19 vaccine developed by the Oxford University in collaboration with British-Swedish pharma company named AstraZeneca.
These vaccines aim for the 2nd and 3rd wolrd countries with low incomes streams like India.
The Pune Based Firm plans to start phase 2 & 3 trials in August in India.