Drugs Controller General of India (DGCI) has given Pune’s Serum Institute of India (SII) the green light for conducting the Phase 2 and 3 human clinical trials of the Covid-19 vaccine. Oxford University has developed the vaccine along with the company AstraZeneca.

“Late (Sunday) night, the DCGI approved the recommendation submitted by the committee and final approval has been issued to SII. DCGI has granted permission for phase 2 and 3 clinical trials of vaccine candidate named, Covishield,” a senior government official told ThePrint.

1600 people above 18 years of age have participated for the vaccine trials. These will be conducted across 19-odd sites like AIIMS Delhi, BJ Medical College Pune, PGIMER Chandigarh, Andhra Medical College Vishakapatnam and more.

Department of Biotechnology (DBT) secretary Dr Renu Swarup had earlier told The Indian Express that these sites had been readied as part of India’s preparations for final stage trials for the Oxford vaccine candidate.

This vaccine is a strong candidate in the race to develop an effective vaccine against Covid-19. SII has a tie-up with Swedish-British pharmaceutical giant AstraZenca to manufacture the vaccine.

Phase 2 and 3 clinical trials of this vaccine are on in the United Kingdom. Phase 3 in Brazil and Phase 1 and 2 in South Africa.

Earlier SII Chief Executive Officer Adar Poonawala had said, “The trials have shown promising results and we are extremely happy about it. We will be applying for the licensure trials to the Indian regulator in a week’s time. As soon as they grant us permission, we will begin with the trials for the vaccine in India.”

Other contenders in the race include Pfizer with BioNTech, and Moderna with the US National Institute of Allergy and Infectious Diseases.  

About SII

Serum Institute of India Pvt. Ltd. is the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses). which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines.

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