VISAKHAPATNAM: Andhra Medical College-King George Hospital has been geared up to conduct the third phase of human trials of coronavirus vaccine Covishield, developed jointly by University of Oxford’s Jenner Institute and AstraZeneca. The Pune-based Serum Institute of India (SII) has partnered with British-Swedish pharmaceutical company AstraZeneca to manufacture the Covid-19 vaccine in India.
A team of SII conducted virtual inspection of facilities and equipment at Andhra Medical College, said Dr PV Sudhakar, AMC principal and co-investigator of vaccine trials. Following the approval of Drug Controller General of India (DCGI), the final stage of clinical trials of Covid-19 vaccine candidates began in Pune and Mumbai. Trials will begin at AMC-KGH soon.
Dr Sudhakar said a 20-member team, including principal investigator B Devi Madhavi, and six co-investigators, was formed for conducting the clinical trials. A training and awareness programme for the team was conducted.
The clinical trials will be conducted as per the ICMR protocol. A two-bed ward has been ready at the AMC for conducting the trials. About 100 volunteers in the age group of 18 to 60 years will be chosen for the trials. Volunteers need to test negative in both RT PCR and antigen tests and they should not have any comorbidities. The vaccine will be administered to three to four volunteers a day.
The process will begin once they get the vaccine and drug from SII. The investigators will not know which one contains the drug or vaccine, Dr Sudhakar said.
He said AMC-KGH was chosen for the clinical trials of Covishield based on its track record of conducting trials for the vaccine for dengue and measles in the past. Volunteers will be in observation at the hospital for two to three hours and later they will be allowed to go home. The need to visit the hospital if they develop any problem. Hospital PROs will monitor the health status of the volunteers on a regular basis by contacting them over phone.