53 volunteers doing fine after first dose of Covid vaccine

Tribune News Service

Chandigarh, October 8

The late-phase human clinical trials of the Oxford-AstraZeneca vaccine, Covishield, are running smoothly at the PGI and those administered the dose have not shown any side effects so far.

Also read: Covaxin trials on track, 2nd dose given to volunteers at Rohtak PGIMS

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

What the PGI says

The second phase of human clinical trials of Covishield, a potential vaccine developed by Oxford University, is going well at the PGI. Till date, 97 volunteers have been screened. Of them, 65 have already been vaccinated since September 25 when the PGI started administering the first dose of the vaccine to the volunteers. Among the 65 volunteers given the first dose, 53 have already completed seven days post-vaccination without any major side effects. — PGI

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

According to the Clinical Trials Registry of India, the occurrence of solicited local and/or systemic adverse events (AEs) is supposed to occur within seven days following each vaccination. The occurrence of unsolicited adverse events can happen 28 days after each vaccination.

These candidates have been administered Covishield under a two-dose schedule (on day 1 and 29) — 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 the prevention of the 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.