PGI trial: 53 participants healthy after first dose of Covid vaccine

Naina Mishra

Tribune News Service

Chandigarh, October 8

The late-phase human clinical trials of the Oxford-AstraZeneca vaccine, which is also known as ‘Covishield’ in India, have been running smoothly at Post Graduate Institute of Medical Education and Research (PGIMER) and have not shown any adverse side-effects so far. 

An official statement released by the institute today reads, “The second phase of human clinical trials of Covishield, the potential vaccine developed by the Oxford University, is going well here at PGIMER. Till date, 97 volunteers have been screened. Of them, 65 volunteers have already been vaccinated since September 25 when PGIMER started administering the first dose of the vaccine to the volunteers. Among 65 volunteers given first dose, 53 have already completed seven days post vaccination without any major side effects.”

However, some participants did develop mild symptoms after the dose of the coronavirus vaccine candidate, which is a mild reaction and is nothing to get alarmed about.

According to clinical registry of India, occurrence of solicited local and/or systemic adverse events (AEs) was supposed to occur within seven days following each vaccination. Occurrence of unsolicited adverse events can happen 28 days after each vaccination.

These candidates have been administered Covishield as 2 dose schedule on days 1 and 29 as 0.5 ml dose intramuscularly.

This is a Phase 2/3, observer-blind, randomised, controlled study in healthy adults in India, for comparison of the safety of COVISHIELD with Oxford/AZ-ChAdOx1 nCoV-19 and Placebo, and immunogenicity with Oxford/AZ-ChAdOx1 nCoV-19 in prevention of SARS CoV-2 infection. 

The participants will be part of immunogenicity cohort and will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Oxford/AZ-ChAdOx1 nCoV-19, respectively. The remaining participants from safety cohort will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Placebo, respectively.