New Delhi | Jagran News Desk: The government has readied five sites across the nation for the third and final phase of human trials of the Oxford-AstraZeneca vaccine for the deadly coronavirus which has afflicted nearly 1.8 crore people across the globe.  

The Oxford and AstraZeneca have partnered with Serum Institute of India, the world’s largest vaccine maker by volume to manufacture the coronavirus vaccine once it is ready. The results for the previous two trials have been published earlier this month.   

Secretary of Department of Biotechnology (DBT) Renu Swarup as quoted by news agency PTI said that “this is an essential step because it is necessary to have data within the country before the vaccine is administered to Indians”.

Swaroop said that the DBT is part of any COVID-19 vaccine effort in India, "whether it is funding, whether it is facilitating the regulatory clearances or whether it is giving them access to different networks which exist within the country".

 

"The DBT is now setting up Phase 3 clinical sites. We have already started working on them and five sites are now ready to be available for Phase 3 trials," Swarup said as quoted by PTI.

"DBT is closely working with every manufacturer and Phase 3 trial of Serum (institute) is important because if the vaccine has to be successful and it has to be given to the Indian population we need to have the data within the country”, she said.

 

"For that a Phase 3 trial has been proposed. Five sites are ready. Within some more weeks, they should be ready for manufacturers to take them up for clinical trial studies," the DBT secretary added.

On July 20, scientists announced that the coronavirus vaccine developed by Oxford University appears safe and induces a strong immune response within the body after the first phase of "promising" human trials against the deadly disease that has infected over 1.45 crore people across the world and claimed more than six lakh lives.

In Phase 1 of human trials, a vaccine is given to a small number of people to test safety. It is also given to check if it stimulates the immune system. In the second phase, it is administered to hundreds of people split into groups such as children and the elderly to see if the vaccine acts differently in them. In the third phase, the vaccine is administered to thousands of people.

The SII has also sought permission from the Drugs Controller General of India (DCGI) for conducting Phase 2 and 3 of human clinical trials of the potential vaccine. It had said earlier it will start manufacturing the vaccine even before the final nod so it is ready with sizable volumes once the vaccine gets all permissions.

 

 

 

(With PTI Inputs)

Posted By: Talib Khan