PUNE: They were the first to receive the Covid-19 vaccines in the country. But hundreds who were part of clinical trials continue to have only rudimentary proof of their fully vaccinated status — in some cases, mentioned on a single sheet of paper with the letterhead of their trial site.
Volunteers said they’ve been unable to get CoWIN certificates despite having received two doses during the tests. The CoWIN certificates — tamper and forgery-proof — are verifiable digital documents. With reports of fake vaccination camps emerging from parts of the country, volunteers also said certificates from trial sites may not pass muster with authorities.
Dr Padmanabh Keskar, a Pune volunteer who has been asking authorities for a CoWIN certificate for the last three months, said, “My wife and I were part of the Covishield phase 3 trials. We were given two doses during the trial in October-November 2020. After the trials, the hospital site gave us a certificate of vaccination with their letterhead. But this certificate carries no value for international travel. Even insurance firms are now asking for CoWIN certificates, which have a secure QR code to protect it from falsification.”
There are indications the government is working on a solution for the volunteers.
A senior health ministry official said, “CoWIN certificates can only be provided to those who are vaccinated through CoWIN. But this matter is being looked into.”
There is, however, a key problem. Dr Samiran Panda, chief of the ICMR’s epidemiology and communicable diseases division, said, “In randomized double blind placebo-controlled clinical trials that test efficacy of a vaccine, one group of participants belong to the intervention arm and are given a vaccine. The other group are the placebo arm. During the trial period, participants and researchers remain blinded to this allocation. In other words, they remain unaware of who gets what. Once the trial is completed and data analysis finished, the unblinding process is undertaken for volunteers to know which arm they were a part of.”
Dr Panda said they have taken up the certification issue for both groups. Those who were in the placebo arm should be vaccinated on priority because of their involvement in the trials, he said.
Dr Ashish Bavdekar, principal investigator of Covishield trials at KEM Hospital, said, “We have been getting requests for CoWIN certificates from trial participants. While we have given each of them a document of proof, verifying their two-dose vaccination, we have also been assured by SII the issue has been taken up with ICMR, which has communicated the matter to the health ministry."
A source from a top city hospital, which was a Covishield trial site, said many from the placebo group were given two options after the unblinding process: either take the vaccine later through the government’s immunization programme or get the shots provided by the vaccine manufacturer for the placebo study participants.
“Almost all of them took the vaccine through the latter route,” the source said.
He added those in the placebo arm, who were later given letter-headed documents as proof of vaccination, are now requesting CoWIN-generated certificates.
