Haryana Health Minister Anil Vij, who was administered a trial dose of Bharat Biotech’s Covid-19 vaccine ‘Covaxin’, on November 20 at a hospital in Ambala, was tested positive for Coronavirus recently.
Vij testing positive even after receiving Covaxin has raised many questions on the effectiveness of the vaccine.
Bharat Biotech is testing the vaccine in a late-stage trial on 25,800 volunteers across the country and with the time frame being reduced for vaccine development, potential risks involved are much higher and the results of human trials are very important for its efficacy.
Here Is An Explainer On The Possible Reason Behind Anil Vij Testing Covid Positive
A press release issued by Bharat Biotech stated: “COVAXIN™ clinical trials are based on two doses 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.”
COVAXINᵀᴹ trials are based on a 2-dose schedule, given 28 days apart. The vaccine efficacy will be determined 2 weeks after the 2nd dose. pic.twitter.com/ZKmGuKbBMf
— Bharat Biotech (@BharatBiotech) December 5, 2020
Covaxin’s phase three trials are double-blinded and randomized, where 50 percent of subjects will receive the vaccine and 50 percent of subjects will receive a placebo, and the investigators, the participants, and the company are not aware of who is assigned to which group.
What is a placebo?
Placebo is a substance that has no therapeutic effect, used as a control in testing new drugs. It could be a pill, a shot, or some other type of “fake” treatment.
How are placebos used?
In vaccine trials, participants are randomized to receive either the vaccine under investigation or a placebo (i.e. an inert substance, such as a saline injection).
Randomization and the use of placebo interventions are designed to control for confounding effects, such that significant differences in disease incidence or adverse effects between the vaccine and control groups can likely be attributed to the vaccine.
According to medical experts, placebos have been essential to clinical trials for decades. It’s vital that neither the volunteers nor the staff running the trial know who is randomly assigned to get the vaccine or the placebo.
This “blinding,” as it’s called, eliminates the chance that people will behave differently depending on which treatment they get, potentially skewing the trial’s results.
Did Anil Vij get a vaccine or a placebo?
As Phase-III trials are double-blinded and randomized so the investigators, the participants, and the company are not aware of who is assigned to which group. Bharat Biotech, the sponsor of the Covaxin trial hasn’t clarified whether the jab given to Vij as part of the trial was the vaccine or not. There is a 50 percent chance that he received the vaccine and a 50 percent chance of getting a placebo.
Why vaccine makers give a placebo instead of a real shot?
Vaccine Experts claim placebos are used to equate the wellbeing of those who have been vaccinated with those who have not been.
What if Vij got the vaccine shot and not a placebo?
With the time frame being reduced for vaccine development, potential risks involved are much higher and the results of human trials are very important for its efficacy.
#WATCH Haryana Health Minister Anil Vij being administered a trial dose of #Covaxin, at a hospital in Ambala.
He had offered to be the first volunteer for the third phase trial of Covaxin, which started in the state today. pic.twitter.com/xKuXWLeFAB
— ANI (@ANI) November 20, 2020
Doctor SP Byotra, Chairman Department of Medicine, Sir Ganga Ram Hospital said: “There is a notion in the public that once a person gets vaccinated he becomes immune to any infection. The truth is that an antigen produces antibodies in a person within a stipulated time. If a person gets the infection even after getting the vaccine then it should not be considered as a failure of the vaccine.”
“However, several vaccines required to be given in two doses as the first is actually a half dose which starts stimulating the production of antibodies. The first dose must be followed by the second one which produces a high level of antibodies in the body,” Byotra added.
Dr. Prasun Chatterjee, Associate Professor, Department of Geriatric Medicine, All India Institute of Medical Sciences said: “Covaxin is a killed virus which once infused in a human body some of the property like surface glycoprotein stimulates antibodies. What is dangerous for Covid is the glycoprotein. One-shot gives partial protection but the booster is better. It stimulates the immune system twice.”
Stressing on Covid-19 appropriate behavior even after being immunized Chatterjee said that one has to follow all health protocols even when the person is immunized.