Haryana home minister Anil Vij. Photo: PTI/File.
New Delhi: A minister’s public admission that he has COVID-19 has raised tricky questions about vaccine trials in India.
Earlier on December 5, Anil Vij, the home minister of Haryana state, tweeted that he has tested positive for COVID-19 and that anyone who’s been around him in the recent past should get tested as well.
Only two weeks ago, Hyderabad-based pharmaceutical company Bharat Biotech had administered an injection to Vij as part of ongoing trials for its COVID-19 vaccine, called Covaxin.
But because the trials were blinded, no one ought to have known at the time if Vij had actually received a dose of Covaxin or the placebo.
(‘Placebo’ refers to the placebo effect, which – broadly – is the phenomenon whereby an individual’s body can stimulate healing if it believes it is receiving treatment even when it isn’t. By giving one group of trial participants a placebo, like a saline solution, researchers can study the extent to which the placebo effect can contribute towards a desirable outcome, and adjust for it in the final data.)
However, now that Vij has tested positive, a flurry of reports have emerged claiming Vij has tested positive even though he received the vaccine. These claims have in turn turned the spotlight on Bharat Biotech, specifically whether company researchers broke clinical trial protocols to check if Vij had received the vaccine candidate or the placebo.
In addition, there also appears to be some confusion over why Vij had tested positive if he had received a dose of the vaccine.
Bharat Biotech has issued a statement defending itself on this count. According to ANI, the company said, “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.”
Vij echoed Bharat Biotech’s statement, and added to PTI that a vaccine recipient is not protect between the time of receiving the first dose and the point at which the vaccine provokes an antibody response.
I have been tested Corona positive. I am admitted in Civil Hospital Ambala Cantt. All those who have come in close contact to me are advised to get themselves tested for corona.
— ANIL VIJ MINISTER HARYANA (@anilvijminister) December 5, 2020
However, Bharat Biotech is yet to comment on whether it had unblinded the trial records to ascertain if Vij had received one dose of Covaxin or the placebo.
Asked about his condition, Vij said he has sore throat, fever and body ache. “But overall I am okay,” he – a senior leader of the ruling Bharatiya Janata Party (BJP) and a legislator from Ambala Cantonment assembly constituency – said.
Vij said he had gone to Panipat a few days ago where he spent a few hours with a BJP leader, who has also tested positive for COVID-19.
“Later, I got myself tested, but the first test returned negative. After some symptoms showed up, the second test was done, which was positive today,” he said.
A three-member delegation of the Jannayak Janta Party (JJP), the BJP’s coalition partner in Haryana, had met Vij on Friday and sought withdrawal of cases registered in the state against farmers participating in the ‘Delhi Chalo’ march against the Centre’s farm laws.
The delegation was led by JJP’s state unit chief Nishan Singh; senior party leader Digvijay Singh Chautala was also part of it. Yoga guru Ramdev had also met Vij on Tuesday in his office, where some journalists were also present.
Earlier, chief minister M.L. Khattar, deputy chief minister Dushyant Chautala, state assembly speaker Gian Chand Gupta and a couple of ministers in the BJP-JJP government had tested positive for COVID-19.
Vij had offered to be the first volunteer in Covaxin’s phase 3 trials. Bharat Biotech has been developing Covaxin with the Indian Council of Medical Research. Vij received his first dose on November 20 at the Ambala Cantonment civil hospital.
Bharat Biotech said on November 22 that Covaxin is expected to be 60% efficacious, and certainly more than 50%, although – as The Wire Science reported then – these claims need to be taken with a pinch of salt.
(With PTI inputs)