Union Health Ministry says Covid-positive Anil Vij took only one dose of Covid vaccine

Aditi Tandon

Tribune News Service

New Delhi, December 5

The government on Saturday clarified that COVID positive status of Haryana Health Minister Anil Vij was not a comment on the efficacy of COVAXIN, indigenous COVID vaccine being developed by Bharat Biotech and ICMR, as the vaccine trial is a two dose regimen and Vij has only been administered one shot yet.

Also read: Days after getting vaccine, Haryana Health Minister Anil Vij tests Covid positive

COVAXIN is just one of the two indigenous COVID vaccines in final stage phase 3 human trials in India, the other being the candidate of Zydus Cadila.

COVAXIN trial results assessed by the Indian drug regulator so far have shown it to be efficacious enough to proceed from phase 2 (trials on limited number of people) to phase 3 which involve multi centric trials on large populations.

Regarding this news:

“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 minister in question has taken only one dose of the vaccine,” a Health Ministry official said.

Bharat Biotech also elaborated the design of the study and said COVAXIN has been designed to be efficacious. 

“COVAXIN clinical trials are based on a 2 dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the 2nd dose.

 COVAXIN has been designed to be efficacious when subjects receive both doses and post the 14 day period after the 2nd dose,” the company said.

The phase 3 trials are double blinded and randomized, where 50 per cent of subjects will receive vaccine and 50 per cent of subjects will receive placebo.

A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results.

COVAXIN is an fully indigenously developed COVID-19 vaccine, with the largest Phase 3 clinical trial conducted in India, in 26,000 subjects across 25 sites.

The goal is evaluate the efficacy of COVAXIN across India.

The phase 3 trials of COVAXIN is the only efficacy trial being conducted in India for COVID-19 vaccines, to determine its suitability to the diverse Indian population.

Infection status doesn’t determine vaccine efficacy: ICMR chief

Meanwhile, the ICMR said infection status of an individual does not determine the efficacy of COVID vaccine.

ICMR is collaborating with Bharat Biotech on COVAXIN, India’s indigenous COVID 19 vaccine.

Speaking to The Tribune on the issue today, ICMR chief Balram Bhargava said, “Participation of political leaders in vaccine trial helps in allaying the fear from people’s mind related to such participation.

“Anybody — either in the vaccine arm or in the placebo arm — can acquire infection.”

Bhargava said final analysis would reveal if the vaccination arm had significantly lower infection rate among participants compared to that in placebo arm, resulting in estimation of efficacy of the vaccine, which is not 100 per cent in any vaccine.

“Infection status of an individual does not determine vaccine efficacy at population level,” he said.

COVAXIN in a double blind trial in which half of the participants receive the vaccine and another half receive the placebo, with neither the receiver nor the experimenter knows who is receiving what.

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