CLINICAL TRIAL MODE

CLINICAL TRIAL MODE

Subject : Science & tech

Context : An expert panel Wednesday recommended the removal of the “clinical trial mode” label attached to the emergency authorisation of Bharat Biotech’s Covid-19 vaccine Covaxin.

Concept :

• Authorisations granted to the Covid-19 vaccines in India so far do not allow for commercial sale — both Covaxin and Covishield have only been approved for use in India’s immunisationprogramme at this time.
• While both vaccines had earlier been granted a restricted use authorisation “in an emergency situation”, the approval to Covaxin was granted “as an abundant precaution”, but on the condition that it be administered in “clinical trial mode”.
• The “clinical trial mode” label meant that the Hyderabad vaccine maker had to seek informed consent prior to administering Covaxin to the healthcare and frontline workers, senior citizens and those with co-morbidities eligible for the government’s ongoing vaccination drive.
• It also meant the company had to submit updates on the safety, immunogenicity and efficacy of the vaccine from its phase 1, 2 and 3 clinical trials more regularly than SII, which has had to submit such data every 15 days so far.
• After this approval, the vaccine would be administered to everyone and they would be monitored closely as if they were in a clinical trial.