Thousands Of Vaccine Trial Volunteers Suffer As Govt Delays Issuing Certificates

Indore-based Vijay Sharma’s father has to go to Itanagar, the capital city of Arunachal Pradesh, for some urgent work but since the state government has made it mandatory for any outsider to carry a vaccination certificate for entering into the state, he is completely clueless about what to do.

Sharma and his parents had participated in the clinical trial of Covaxin in Maharaja Agrasen Superspecilaity Hospital in Jaipur in November last year. Each one of them had got two doses after a gap of a month.

Six months later, the hospital disclosed to Sharma that his parents had got the vaccine whereas he was administered a placebo.

“My father has already been vaccinated but since he didn’t go through CoWin application, he didn’t have any proof of it. The hospital has given him an acknowledgement letter on its letterhead but that’s not a valid document,” Sharma said.

He added, “The hospital had promised me that those who had got a placebo would get the vaccine free of cost on priority for their contribution but I never got that. I had to apply through the CoWin app in Indore in some other vaccination centre.”

Besides Sharma and his family, thousands of people in the country who took part in the clinical trials of Covaxin and Covishield haven’t received any vaccine certificate. 

Outlook spoke to more than a dozen volunteers who shared their frustrations saying that they are feeling cheated now as neither the government nor the pharmaceutical companies have lived up to their promises.

“Forget about any reward or applause, the government hasn’t even issued a proper certificate about my vaccination status almost a year after taking the jab. This is the reward for putting my life at risk in this country,” Shivanand S Gokhale, who volunteered in Phase II trial of Covishield in Pune’s Bharti Vidyapeeth Deemed University Medical College and Hospital in August last year, said.

He added, “Today, I regret why I didn't take the jab like others through the CoWin app. I am surprised with the government’s apathy and red-tapism.”

A Delhi-based 22-year-old student, who had to go to Estonia, a country in northern Europe, changed his plan because his hospital vaccination letter was not considered valid for a visa. 

“My travel agent informed me that the country asks unvaccinated people to serve a quarantine period. I couldn’t afford to do that so I had to change my plan,” he said requesting anonymity.

He added, “I didn’t want to run from pillar to post to find out a solution because I know nothing will happen in the end.”

Another Pune-based volunteer Santosh K More, whose daughter has also participated in a vaccine trial for children recently, says that those who got vaccines in the clinical trial should have been automatically given the certificate by the health authorities.

“I know so many volunteers who are facing a plethora of problems. They are working in private companies, educational institutions and commercial establishments and their employers are insisting on vaccine certificates,” More said.

He added, “Being a consultant, I have to go to several companies and many places, I cannot go because they don’t honour hospital letters.”  

Many other volunteers say that the letter by any hospital would definitely not be counted as authentic proof, especially abroad, in view of the fake vaccination racket busted recently.

Principle investigators in various hospitals where the clinical trial took place say that they have no role in awarding any certificate.

“The Indian Council of Medical Research (ICMR) directed us to submit all the volunteers’ data with it so we did that. Now it is with the ICMR to issue vaccine certificates,” Dr Mohammad Shameem, Principal investigator for Covaxin in the Aligarh Muslim University (AMU) said. AMU was one of the 26 hospitals in the country where Phase II/III clinical trials for Covaxin took place.    

“We had requested the ICMR to give us authority to register volunteers on CoWin app but it refused,” Another Principal Investigator said requesting anonymity.

ICMR scientist Dr Nivedita Gupta admitted that it is ICMR’s job to get vaccine certificates issued to these volunteers from the Ministry of Health and Family Welfare.

When asked how long will it take to do the needful she said, “I can’t comment on the timeline. ICMR is following it up with the Health Ministry.”