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Sunday, September 26, 2021

Year later, many participants of vaccine trials await certification

A year later, he has to furnish RT-PCR test results every time he has to board a flight, because, unlike other vaccinated people, he still doesn’t have a government software-generated certificate.

Written by Anuradha Mascarenhas | Pune |
Updated: August 22, 2021 7:16:43 am
A file photo of a Covaxin trial in Ahmedabad. Participants are unable to generate a certificate from the CoWin app, which is being accepted as proof of vaccination. (Express Photo: Nirmal Harindran/File)

A K Khanna, 65, a former top official at a pharmaceutical firm and presently chairman of a healthcare company, was among the first five participants in the clinical trials of Covishield vaccine conducted by the Serum Institute of India and the Indian Council of Medical Research (ICMR) a year ago. Along with his wife and daughter, Khanna received his vaccine doses in August last year.

A year later, he has to furnish RT-PCR test results every time he has to board a flight, because, unlike other vaccinated people, he still doesn’t have a government software-generated certificate. The one that the trial site had provided has often been dubbed “fake”.

“How long do I wait for the government to certify that my family and I have got both doses? At Jammu airport recently, the authorities rejected the certificate issued by the trial site (in his case Bharati Hospital in Pune), as it was not original,” Khanna said. “I knew this problem would arise. So I had got an RT-PCR test (done) a day earlier. But this is so unfair. At a time when not many were willing to get injected with a vaccine, we had volunteered and even convinced several others to get the shot.

“For the last three months I have been constantly asking authorities but (I am) told that the matter is being looked into.”

Khanna is not alone. There are 1,600 volunteers who participated in the Covishield trials, and 25,800 who were part of Covaxin trials conducted by Bharat Biotech. Of the 25,800 participants in the Covaxin trials, a Bharat Biotech official said, 50% were vaccine recipients, and the other half were placebo recipients. “The placebo recipients were contacted after trial completion and were administered vaccines,” the official said.

All these people received a certificate from the trial sites, stating that they had received vaccines during trials. But none of them could generate a certificate from the CoWin app, which is being accepted as proof of vaccination.

Pune-based industrialist Hemant Katakkar, 64, is in a similar predicament. Katakkar had, in fact, motivated 20 other volunteers to participate in the phase-2/3 trials of Covishield.

“The trial was a double-blinded one and hence some got the vaccine and others got placebo,” he said. “When the trial was unblinded, we were told that along with my daughter and driver, I had also not received the vaccine shot. We got the placebo. However, at that point we were immediately administered the vaccine shot.”

This was in March this year. “Since we were part of the trial, we were not included in the CoWin software that was issuing provisional and final certificates,” Katakkar said.

“I even wrote to the Prime Minister’s Office. It responded saying the issue had been resolved. We are still waiting for our certificates,” he said.

Katakkar said one of his friends was unable to get a business visa for Dubai since the certificate issued by the trial site was not accepted.

A freelance writer in Pune, who also participated in the trials, said she was stopped at a shopping mall recently since she could not present CoWin app-generated certificate. “I had participated in the trials at Jehangir Hospital. We have been assured that official certification for us is being organised. However, we haven’t got any time-line for this,” she said.

The trials for Covishield were conducted at 15 sites in different cities and were completed by October last year. The Covaxin trials were completed a couple of weeks later.

Dr Sanjay Lalwani, medical director at Bharati Hospital, one of the trial sites, said the issue of providing official certificates to the participants had recently been discussed with ICMR. “We have been informed that the Centre is looking into the issue and will issue certificates soon,” he said.

Dr Ashish Bavdekar, principal investigator of the Covishield trial at KEM Hospital Research Centre’s Vadu Rural Health Programme site, said he has also been informed that official certificates were being provided to all participants. “Trial sites were asked to submit details of the first and second dose administered to participants and the data was submitted to ICMR. The Centre wants the details in a specific format and the hope is now that certificates will be issued shortly,” Dr Bavdekar said.

Bharat Biotech officials said they are working with the Union Health Ministry on this.

Samiran Panda, chief of epidemiology and communicable diseases division of ICMR, said the matter is being processed. “We are trying to see how the CoWin software can allot this certificate and the entire process has been expedited,” Dr Panda said.

“I have raised this issue as a rights-based one, and ICMR has proactively interacted with the vaccine manufacturing companies and Health Ministry so that the trial participants get their certificates through the CoWin software. We are aware of this issue and it concerns trial participants of both Covishield and Covaxin,” he said.

Union Health Secretary Rajesh Bhushan said changes are being made in the CoWin app so that certificates can be issued.

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