By Ashish Srivastava
New Delhi, Oct 8 (IANS) The late phase trials of the Oxford-AstraZeneca vaccine, known as Covishield in India, are well underway at the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, the institute said on Thursday.
The officials at the premier institute told IANS that no adverse side-effects among the volunteers have been observed so far.
“Very few people developed fever or body ache post vaccine administration. It is expected and very normal after the vaccine dose is given. Nothing to get alarmed about,” an official informed.
The institute is listed as one of the 17 trial sites for conducting the second and third phases of human clinical trials of the Coveshield vaccine.
The officials added that 53 participants in the trials have already completed seven days of post vaccination period without developing any major side-effects. They also informed that the institute has screened 97 volunteers till date and 65 of them have already been administered the first dose of the vaccine.
The Covishield vaccine has been developed by the Oxford University and is being mass-produced by the Pune-based Serum Institute of India (SII).
PGIMR started the vaccine trials on September 25 when two females aged 57 and 26 years and a 33-year-old male were administered the vaccine candidate at the institute.
The trials at the PGIMER were started after the institute received safety approval from the Data Safety and Monitoring Board (DSMB) for the first 100 candidates selected to undergo the trials last month.
The institute will administer multiple doses of the vaccine candidate to check its safety and efficacy over more than 250 participants. A gap of 28 days would be maintained between the doses measuring 0.5 ml each.
The trials of Covishield were halted last month in the UK and India after an advert incident happened with a participant in London. The participant had reported a suspected severe adverse reaction when he was administered a booster dose of Covishield.
Following that, the Medicines Health Regulatory Authority of the UK had halted the trials there. The Central Drugs Standard Control Organisation (CDSCO) had also taken conginasance of the reported incident and had ordered the SII to halt the trials in India.
The trials were resumed in the UK on September 12 after a go-ahead from the UK’s drug regulatory authority. Trials resumed in India the same week.