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SII seeks govt nod to ‘unblind’ trial data

The Serum Institute of India (SII), which secured emergency use authorisation for the Covishield Covid-19 vaccine earlier this month, has now applied for permission from the Drugs Controller General of India (DCGI) to “unblind” the data of its ongoing phase 3 trial, ThePrint has learnt.

Sources in the SII told ThePrint that the company is awaiting approval from the DCGI to unblind phase 3 data so that volunteers may know whether they were part of the vaccine arm or placebo arm of the trial. Sources said the SII had applied for the permission last week.

Under normal circumstances, the information about whether a volunteer is given a placebo or the vaccine in a phase 3 trial is kept with the sponsor — the Serum Institute, in this case — and revealed only at the end of the trial, with approvals from the drug regulator.

However, since the vaccine was approved for emergency use authorisation on 3 January, vaccine volunteers, some of whom are healthcare workers, are keen to know whether they got the vaccine or not.

“We were getting many requests from volunteers since the vaccination process started, so we wrote to the DCGI as well as the various ethics committees to ask if we can inform the volunteers about whether they got the vaccine or placebo,” said a source.

“If they give the approvals, we will go ahead and tell the volunteers which arm of the trial they were part of,” the source added.

Anxious volunteers
As part of its phase 3 trial, SII had roped in 1,600 volunteers from 14 trial sites. The trial began in August 2020, and is slated to continue till at least March this year.

When Covishield was given restricted emergency use authorisation, several volunteers expected to be told about whether they had received the shot or just a placebo.

“I remember when I agreed to be part of the trial, I was told we would be given the vaccine on priority if it is given approval. It’s disappointing that the volunteers haven’t been told anything after the vaccine was approved,” said 63-year-old Hemant Vasant Katakkar, a volunteer from Pune.

“We need to know if we should take the vaccine when our turn comes.”

Anuradha Trehan, another volunteer from Pune, said, “We were told that, at the end of the trial, those who got the placebo would be given the vaccine. They didn’t mention anything about what would happen if approval is given before.”

“My husband and I both participated in the trial, and we would like to know where we stand right now, because we took such a big risk,” the 45-year-old added.

A second source from the Serum Institute said the trial would continue even after the data is unblinded, provided the DCGI grants approval.

“The trial will continue, and the participants will still be observed. The vaccine is not on the market yet, so till such time that it is, the trial will continue,” the source said.

Confusion over healthcare workers
Principal investigators (PI) of the various trial sites are unsure of what the emergency use authorisation means for healthcare workers who participated in the trial, and are now eligible for the Covid-19 vaccine under the government’s immunisation programme.

The first Serum source told ThePrint that the status of healthcare workers who volunteered for the trial would be revealed to them if they asked. However, some principal investigators told ThePrint they received no such direction.

“I have advised all the healthcare workers who were volunteers at our site to avoid taking the vaccine till there is more clarity. So far, Serum has not told us anything,” said a PI from a hospital in Maharashtra.

“I had asked Serum Institute about what to do if a healthcare volunteer asked about their status, and they said that that data would be released. But so far, I have not received such a request,” said a PI of a hospital in a northern state. – The Print

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