One year later, many trial participants still to receive certification


When Serum Institute of India and the Indian Council of Medical Research (ICMR) conducted clinical trials for Covishield a year ago, A.K. Khanna was among the first five participants to sign up. Khanna, currently the chairman of a healthcare company and a former top official at a pharmaceutical company, his wife, and daughter received their doses in August 2020.

A year later, Khanna still has to show a negative RT-PCR report every time he boards a flight. Unlike vaccinated people, he doesn’t have a software-generated government vaccination certificate. The certificate that he was provided by the trial site has often been called “fake”.

Khanna told The Indian Express that the Jammu airport authorities recently rejected the certificate he was issued by Pune’s Bharati Hospital, the trial site, as it was not the original. He asked how long he had to wait to be certified by the government for getting both the doses.

He said he anticipated the problem and had got an RT-PCR test done. Khanna said when not many people were willing to go for the trial at the time, they not only volunteered but also convinced others to get a shot.

Khanna said that he had been asking authorities for a resolution for the past three months, and was being told that they were looking into the matter.

Khanna is not facing the problem alone, however. The Covishield trial included 1,600 volunteers, while 25,800 people took part in Bharat Biotech’s trials for Covaxin. A Bharat Biotech official said 50 per cent of the 25,800 participants received the vaccine, while the remainder received placebo. The official added that the company contacted the placebo recipients following the trial and were given the vaccine.

While they received certificates from trial sites that said they had received the vaccines during the trials, they could not generate a certificate from CoWin.

Hemant Katakkar, a Pune-based industrialist, is facing a similar problem. Katakkar had also motivated 20 volunteers to take part in Covishield’s phase-2/3 trials in March.

Katakkar said the double-blinded trial meant some participants got the vaccine, while some others got placebo. At the end of the trial, he was told that he, his daughter, and driver had not received the vaccine. However, at that point, they were immediately administered the vaccine.

He said they were not included in CoWin since they were part of the trial. Katakkar also wrote to the Prime Minister’s Office, which responded by saying that the issue had been resolved. However, Katakkar and his family members are still waiting for the certificates.

Katakkar said his friend was refused a business visa for Dubai since the trial site certificate was rejected.

A Pune-based freelance writer who also took part in the trials was recently stopped at a shopping mall since she could not show the CoWin -generated certificate. She had taken part in the trials held at Jehangir Hospital. She said they were assured that official certification was being organised for them. However, they have not been provided any timeline.

The Covishield trials were held at 15 sites and completed by last October. The Covaxin trials ended a couple of weeks after.

Bharati Hospital Medical Director Dr. Sanjay Lalwani said the issue had recently been discussed with ICMR. He said they were told the Centre was looking into the issue and would issue the certificates shirtly.

Dr. Ashish Bavdekar, the principal investigator of the trials for Covishield at KEM Hospital Research Centre, said he had also been told that official certificates would be provided to participants. He said trial sites were told to submit details of the two doses and the data was sent to ICMR. The Centre had asked for the details in a specific manner, adding that he hoped the certificates would be issued shortly.

ICMR’s head of epidemiology and communicable diseases Samiran Panda said they were looking at how CoWin could allot the certificate and that the process had been expedited.

Panda said he had raised the issues as a rights-based one, with ICMR interacting with the vaccine manufacturers and the health ministry so that the participants can get their certificates through CoWin. He added that they were of the issue.

Union Health Secretary Rajesh Bhushan told The Indian Express that the CoWin app was being changed so that it could issue the certificates.

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