India’s top drug regulatory body DCGI (The Drugs Controller General of India) finally gave green signal to Serum Institute of India (SII) for conducting phase II and III clinical trials of Astra Zeneca vaccine developed by the Oxford University against coronavirus disease. The approval came after scrutiny was done based on the recommendations of the group of a medical expert on COVID-19.

Background  

The global pandemic has forced top medical experts and scientists to develop a safe and effective vaccine against the disease. Since then several experiments have taken place and some of them have even shown promising results in early trials. Currently, at least 26 vaccines are in a clinical evaluation with six of them in late-stage, phase 3 trials according to a report published by the World Health Organization (WHO). As of July 31, WHO’s draft of the landscape of COVID-19 vaccine shows that nearly 139 candidate vaccines are in preclinical evaluation. Millions of people worldwide are affected by the deadly virus. As the deadly virus continues to spread, researchers are working hard using different methods to find a permanent solution against COVID-19. Several large-scale studies are in pipeline to assess the safety and efficiency of some of the most advanced vaccine candidates, including the Moderna mRNA vaccine, Pfizer-BioNTech candidate, and Oxford’s Astra Zeneca COVID-19 vaccine etc. Amidst all this progress a report from Russia claims that preparation of mass vaccination against CVOID-19 is set to be completed by October. However, the country is yet to release any scientific data on its vaccine trials.

About the trial

Around 1,600 people will participate in the clinical trial proposed to be undertaken at 17 selected institutes across the country which are, AIIMS-Delhi, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam, JSS Academy of Higher Education and Research in Mysore, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, and Post Graduate Institute of Medical Education and Research in Chandigarh. Those volunteers who will take part in the clinical trial must be above 18 years old.  Each one of them will be administered two doses four weeks apart. On day one first dose will be administered then following 29 days the second dose of medicine will be administered.

Previous Results

The initial trial results of Covi-shield vaccine on candidate published in the medical journal “The Lancet” has been made public by the Oxford University and it has shown promising results.  The preliminary trial results published in the medical journal stated that the vaccine candidate was safe and induced immune reaction against SARS-CoV-2, which causes Covid-19 and protect healthy people from infection.

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