AK Khanna, 65, a former top executive of a pharmaceutical firm and currently the chairman of a healthcare company, was among the first five participants in a clinical trial of the Kovidshield vaccine conducted by the Serum Institute of India and the Indian Council of Medical Research (ICMR). ) one year ago. Khanna along with his wife and daughter had received the vaccine dose in August last year.
A year later, they have to submit RT-PCR test results every time they fly because, unlike other vaccinated people, they still don’t have a government software-generated certificate. What the test site provided has often been labeled “fake”.
“How long should I wait for the government to certify that both my family and I have received the dose? Recently at the Jammu airport, the authorities rejected the certificate issued by the test site (Bharti Hospital in Pune in their case) as it was not original,” Khanna said. “I knew this problem would arise. So I had (done) the RT-PCR test a day ago. But it is so unfair. At a time when many people were not ready to inject the vaccine, we volunteered. Se and many others were also persuaded to get vaccinated.
“For the last three months I have been continuously asking the authorities but (I have been told) that the matter is being looked into.”
Khanna is not alone. 1,600 volunteers participated in the Covishield trials, and 25,800 who were part of covaxin Testing done by Bharat Biotech. A Bharat Biotech official said that of the 25,800 participants involved in the Covaxin trials, 50% were vaccine recipients, and the other half were placebo recipients. “After the completion of the trial, the placebo recipients were contacted and vaccinated,” the official said.
All these people got a certificate from the testing sites saying that they had received the vaccines during the trial. But none of them could generate the certificate from CoWin app, which is being accepted as proof of vaccination.
Pune-based industrialist Hemant Katakkar, 64, is also in a similar situation. “The trial was a double-blind and so some got the vaccine and others got a placebo,” he said. “When the testing was indiscriminate, we were told that along with my daughter and the driver, I too had not received the vaccine shot. We got the placebo. However, at that time we were immediately given 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 the provisional and final certificates,” Katakkar said.
Trials for Covishield were conducted at 15 sites in different cities and were completed by October last year. The Covaxin trial was completed a few weeks later.
Dr Sanjay Lalwani, Medical Director of Bharti Hospital, one of the trial sites, said the issue of providing official certificates to the participants was discussed with the ICMR recently. “We have been informed that the Center is looking into the issue and will issue the certificate soon,” he said.
Dr Ashish Bawdekar, principal investigator of the Covishield trial at the Vadu Rural Health event site of KEM Hospital Research Centre, said he has also been informed that official certificates are being provided to all participants. “The trial sites were asked to submit the details of the first and second doses administered to the participants and the data was submitted to ICMR. The Center wants the details in a specific format and now it is expected that the certificates will be issued soon,” Dr Bavdekar said.
Bharat Biotech officials said that they are working with the Union Health Ministry on this.
Samiran Panda, head of ICMR’s department of epidemiology and communicable diseases, said that the matter is being processed. “We are trying to see how the CoWin software can assign this certificate and the whole process has been expedited,” said Dr. Panda.
“I have taken up this issue as a rights-based one, and ICMR is actively in dialogue with vaccine manufacturing companies and the Ministry of Health to enable trial participants to get their certificates through the CoWin software. We are aware of the issue and it pertains to trial participants of both Covishield and Covaxin,” he said.
Union Health Secretary Rajesh Bhushan said that changes are being made in the CoWin app so that certificates can be issued.
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