NEW DELHI/ CHANDIGARH: A Haryana minister's tweet and a statement by the Union health ministry identifying him as the recipient of a Covid-19 vaccine on Saturday kicked up a major controversy as experts pointed out that they constitute either irresponsible statements or a breach in research integrity.
Anil Vij, the health minister of Haryana, announced that he had tested positive for the disease, nearly two weeks after making public that he had been administered the first dose of Covaxin as part of the experimental vaccine's phase 3 trial.
Covaxin is an indigenously developed potential Covid-19 vaccine developed by Bharat Biotech and the ICMR, and is currently being tested on nearly 26,000 volunteers in the final stage of the trial.
"I have been tested Corona positive. I am admitted in Civil Hospital Ambala Cantt. All those who have come in close contact with me are advised to get themselves tested for corona," Vij wrote on Twitter.
Earlier, on November 19, a day before the highly publicised event in which he was administered the jab, he had tweeted, "I will be administered a trial dose of Coronavirus vaccine Covaxin, a Bharat Biotech product, tomorrow at 11 am at Civil Hospital, Ambala Cantt under the expert supervision of a team of Doctors from PGI Rohtak and Health Department. I have volunteered to take the trial dose."
The Saturday announcement triggered a flurry of criticism on the ham-handedness of the sponsors of the trial as many saw it as a breach of trial terms, which says it is a double-blinded, randomised trial, suggesting that neither the participants nor investigators knew whether they are receiving the actual vaccine or dummy shots.
Some also questioned the efficacy of the vaccine, saying that the minister contracted Covid-19 even after getting its dose administered.
The Union ministry of health and family welfare said that "the anti-bodies against the infection build up in a human being only after a specific number of days pass after the second dose of the vaccine is taken since this is a two-dose vaccine."
The clarification made things worse as it was read to imply that even the ministry knew that Vij had indeed received the vaccine and also made it public.
In a statement issued, Bharat Biotech without specifically mentioning Vij's name, on the other hand, said that Covaxin clinical trials are based on a two-dose schedule, given 28 days apart.
"The vaccine efficacy will be determined 14 days post the second dose. Covaxin has been designed to be efficacious when subjects receive both doses and post the 14-day period after the second dose," it said.
The company added that the phase 3 trials are double-blinded and randomized, where 50% of subjects will receive vaccines and 50% of subjects will receive placebo.
Savita Varma, principal investigator of the trial at the PGI, Rohtak under whose aegis Vij has participated in the trial, refused to comment on the issue.
Another senior researcher, associated with the project, however, insisted that the minister did not know whether he had got the vaccine or placebo but probably put out a misleading public statement due to lack of awareness.
Santanu Tripathi, expert clinical pharmacologist and clinical trialist from Kolkata, meanwhile, said, "It is not surprising that a trial participant having received the vaccine shot contracts corona infection or is hospitalised due to the severe Covid-19."
"If a participant is diagnosed with Covid-19 during the trial period, this is no doubt a serious adverse event. Establishing relatedness of the event to the study vaccine or procedures needs to be ascertained but it is unlikely to be induced by the trial medication - either vaccine or placebo."
"In an exceptional situation, in the interest of the participant’s well-being and health, the investigator may urge to decode the blinding and know the real identity of the trial medication," Tripathi also explained adding that in this case no such necessity is apparent.
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