Completed clinical trials data for Covid-19 vaccines to be unblinded
Completed clinical trials data for Covid-19 vaccines will be unblinded and those who have received the jab will be given a certificate through the government’s CoWIN platform, an official said.
“An order has been issued... ICMR (Indian Council of Medical Research) has been asked to share a list of those who participated in the vaccine trial. The certificate will be generated only for those who got the actual vaccine and not the placebo,” said Lav Agarwal, joint secretary, Union health ministry, at a press briefing on Tuesday. Such certificates will only be issued for trials that have been completed so that the integrity of ongoing trials is maintained, he said.
So far, Bharat Biotech’s Covaxin has completed its phase III large clinical trials that found it to be 78% effective in preventing symptomatic infection. The study of children is going on.
Serum Institute of India’s Covishield has completed its immunogenicity bridging trial to show that it produces a similar immune response as seen elsewhere.
Only the interim data for the indigenous vaccine by Zydus Cadila has been analysed so far. The trial participants for ZyCoV-D will have to wait for such certificates.
The protein subunit vaccine by BiologicalE is also in phase III clinical trials.
In phase III clinical trials, a proportion of a large number of participants is administered a placebo (an agent without therapeutic value) to evaluate how many infections the actual vaccine prevented. The studies are usually double-blinded, meaning neither the participants nor those administering the vaccine and studying its impact know whether a person has received a vaccine or placebo.
The data is unblinded only once a certain pre-decided number of infections happen among the participants.
So far, the participants in vaccine trials in India have received a certificate from the trial sites. However, these are not accepted as proof of vaccination.
“The persons who had participated in clinical trials had received paper-based certificates initially. A QR code-based certificate will be generated on CoWIN for them. They will be able to download it using their mobile numbers. The certificates will be generated only for the vaccines that have already received an Emergency Use Authorisation,” said Agarwal.
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