BHOPAL: Volunteers who were given two shots of Covaxin during the trials are still under six months’ observation, which will last till end-May. However, the Union health ministry has given permission for emergency use of both Covishield and Covaxin. But, as far as the trials are concerned, Covaxin trials are still on, so, there is a need for signing the consent form at the time of the vaccination.
People’s College of Medical Sciences & Research Centre (PCMS) is conducting trials and both the doses of Covaxin were completed by January 10. In the first round, there were 1,700 volunteers who were given the shots and, in the second round, around 1,500 volunteers were given the shots. Those who tested Covid-positive and defaulters who missed the second dose of Covaxin and its trials are in a ‘double-blind, placebo-controlled’ clinical trial.
In the trials, no one — not even the research team — knows who gets the treatment, the placebo, or another intervention. When the participants, family members and staff all are “blind” to the treatment while the study is underway, the study is called a “double-blind, placebo-controlled” clinical trial.
‘Close vigil on volunteers’
"Both the doses prescribed during the trials have been completed by January 10 in PCMS and now follow-up or observation continues. We’re keeping a close vigil on volunteers according to protocol. Now, a six-month period for observation is in protocol. The first dose was given on November 27. So, the six-month observation period will be counted from that date and it’ll last till end-May," said Dr Anil Dixit, PCMS dean.
