Covishield trial volunteers to be offered vaccine again

Naina Mishra

Tribune News Service

Chandigarh, January 6

Those who have participated in the Covishield vaccine trials at the PGI will gain be offered a shot of the vaccine by the Serum Institute of India (SII) if their antibody levels are not satisfactory.

After deliberations, the subject expert committee recommended for the grant of permission for restricted use in an emergency situation subject to certain regulatory conditions in India.

A PGI doctor involved in the vaccine trials explains: "The vaccine has been approved for emergency usage in the country based on the data generated from the trials, which was found comparable with the data from the overseas clinical studies. The ongoing clinical trials at the PGI will also continue."

"After the conclusion of the trials, the Serum Institute of India will undertake a procedure to ascertain the candidates who have received a placebo so that they are not left out of the vaccination drive. Besides, those who had already received Covishield shots will be offered vaccination again if their antibody levels are not found to be satisfactory," said the PGI doctor.

The trials at the PGI are observer-blind, in which neither the doctors and nor the volunteers know who has received a placebo. A placebo, which is often a fake drug, is used in clinical trials for the psychological benefit of the volunteer.

The vaccine can be stored at 2 to 8 degree centigrade (household refrigerator temperature) and has to be taken in two doses with intramuscular injections at a gap of 28 days. No side-effects were observed in volunteers during the Covishield trials at the PGI. Dr Jagat Ram, Director, PGI, said the trial for both doses was conducted successfully on 149 volunteers.

The SII is conducting a Phase 2/3 bridge trials in India on 1,600 people. Global trials of the vaccine have been conducted by AstraZeneca, which developed the vaccine with Oxford University.

from The Tribune https://ift.tt/2Lwmqu3