After DCGI nod to Serum institute, trial sites wait for go-ahead to resume enrolment of volunteers

On September 11, the DCGI had directed the institute to suspend any new recruitment till further orders as the pharma firm AstraZeneca had paused clinical trials in other countries because of an unexplained illness in a participant in the study. Subsequently, AstraZeneca and University of Oxford had said clinical trials for the vaccine candidate had resumed in the UK.

The Serum institute had also sought permission from the DGCI to restart the re-enrollment procedure for Covid-19 vaccine following the Data Safety Monitoring Board’s recommendations. The DCGI, in its letter to SII, has given the go-ahead but called for a revised informed consent form and additional safety monitoring plan for the participants.

While extra care has to be taken during screening, close monitoring has been necessitated for similar events during the study follow-up, read the letter from the DCGI.

From among the 17 trial sites, four are in Pune, of which three had been involved in administering the Covishield vaccine dose as the initial part of the phase II clinical study. A total of 100 participants across KEM Hospital and Research Centre at Vadu, Bharati Hospital, Sassoon General Hospital and JSS Medical College and Hospital have been administered the dose.

At the clinical trial sites, experts involved in the study said that they hope to get a clearance from SII in the next two to three days. “Some changes have been mandated by the DCGI, like a revised informed consent form, and these details have to be approved by each clinical trial site’s ethical committee. We hope to start enrolling volunteers by next week,” said an expert.