DCGI nod to Serum Institute for conducting human trials of Oxford vaccine

New Delhi: Pune based Serum Institute of India (SII) has received approval from Drugs Controller General of India (DCGI) to conduct phase 2 and 3 human trials of the Oxford-AstraZeneca COVID-19 vaccine candidate in India.

The approval came from DCGI, Dr V G Somani, who declared after a thorough evaluation and recommendations from the Subject Expert Committee (SEC) on COVID-19, that Serum Institute was permitted to carry out the trials.

Currently, the Oxford-AstraZeneca vaccine candidate (called AZD1222) is in the midst of phase 2 and 3 clinical trials in the United Kingdom, phase 3 trials in Brazil, and phase 1 and 2 clinical trials in South Africa. In data released from the phase 1/2 study in 1,077 healthy volunteers, AZD1222 was found to trigger two unique, important immune responses against COVID-19.

The CDSCO expert panel which reportedly met last week, had asked SII to revise its protocol for phase 2 and 3 clinical trials, besides seeking some additional information. It had also suggested that Serum Institute pick clinical trial sites distributed widely across India.

As per media reports, Serum’s revised proposal includes the enrolment of 1,600 healthy volunteers over age 18 for trials to be conducted in 17 chosen sites – AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.

The phase 2 and 3 trials will be an observer-blind, randomized controlled study to determine the safety and immunogenicity of the Oxford vaccine, dubbed ‘Covishield’, on healthy Indian adults.

Serum Institute has partnered with AstraZeneca to manufacture the vaccine, declaring in a statement that it will manufacture a billion doses of the vaccine after clearance from regulatory authorities.

Serum Institute of India is also currently carrying out a randomized, double-blind study of a recombinant BCG vaccine (VPM1002 for severe cases of coronavirus infection. The vaccine is a further development of the 100-year-old Bacillus Calmette-Guérin (BCG) vaccine that is still widely used to treat tuberculosis. In the ongoing Phase 3 trials in 5,946 volunteers, Serum Institute is testing whether the vaccine reduces the severity of COVID-19 in high-risk patients. The company is also in partnership with US-based Codagenix, to develop a live attenuated COVID-19 vaccine candidate called CDX-005, which is in pre-clinical trials as of 31 July 2020.