Haryana Home and Health Minister Anil Vij on Saturday tested positive for coronavirus. Taking to Twitter, Anil Vij confirmed he has tested positive for COVID-19 and has been admitted to Civil Hospital Ambala Cantt.
“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 wrote on Twitter.
This comes days after Anil Vij was administered a dose of Covaxin at a hospital in Ambala, as part of its third phase trial. On November 20, Vij had offered to be the first volunteer for the third phase trial of Covaxin, which started in the state.
Bharat Biotech which is developing Covaxin in collaboration with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Pune, had on November 16 (Monday) announced the commencement of Phase 3 trials of Covaxin, involving 26,000 volunteers across 25 centres in India.
The reports of Haryana Minister Anil Vij testing positive for the coronavirus even after volunteering for the third phase trials of the Covaxin vaccine trails has now caused panic among citizens in the country. The hysteria and sensationalism in some parts of the media have pushed some people to believe that the coronavirus vaccine developed by Bharat Biotech was a failure and the Haryana Minister contracted the virus only after he was injected with a vaccine during the test phase.
However, with limited information in the public regarding the Covaxin trails, it is entirely misleading to claim that the Haryana Minister tested positive for the coronavirus after he was injected with the vaccine. Despite, Haryana Minister Anil Vij testing positive for the coronavirus just days after him being subjected to vaccine trails is not a sign of worry or panic.
Covaxin trial is double blinded
Bharat Biotech carried out India’s first phase 3 efficacy study for a Covid-19 vaccine ‘Covaxin’ and it is the largest phase-3 efficacy trial ever conducted in India.
During the trials, these volunteers, including Anil Vij, will receive two intramuscular injections on a gap of 28 days. These participants were randomly assigned to receive Covaxin or ‘placebo’, a dummy drug that does not have any effect. The trial is double-blinded, therefore the investigators, the participants and the company are not aware who is assigned to which group. The participants are identified by numbers, not names, in the study records, and only a select few people have access to the record that links the numbers to the names. Therefore, when the study results are analysed, the researchers can’t link them to individual participants.
A placebo is a simple saline solution commonly used during vaccine trials. Randomised, placebo-controlled trials are considered to be safe and the ‘gold standard’ for evaluating the safety and efficacy of a new medicine or vaccine. In these trials, participants are randomized to receive either the vaccine under investigation or a placebo such as a saline injection.
The randomisation and the use of placebo interventions are designed to control for unexpected effects or disease incidence between the vaccine and control groups that can likely be attributed to the vaccine. In fact, the researchers use placebos during trials to help them understand what effect a new vaccine or some other treatment might have on a particular condition.
In some cases, a person under trial, who has been injected with the placebo can show responses. For instance, the subject can show improvement or the person may also see some side effects from the treatment. These responses are known as the “placebo effect.”
Here is why there is no need to panic
As Haryana Minister Anil Vij received the vaccine dose as part of the phase 3 trial, actually it is not known whether he received the actual vaccine or the placebo. As it is a double-blind study, neither the participants nor the doctors know who is receiving what. Therefore, Vij may have not been inoculated with the actual vaccine during the Phase 3 trials of Bharat Biotech’s Covaxin at all. There is 50% chance that Anil Vij may have been injected with a placebo. Thus, he may have been showing positive symptoms for the coronavirus without being injected with the actual vaccine.
Moreover, it is also important to note that like most Coronavirus vaccines under development, the Covaxin also requires two doses. The Bharat Biotech’s vaccine he received on November 20 has a two-dose schedule at a 28-day interval. He only received the first dose. The vaccine will work properly only after both doses are received by the participants. Therefore, even if he had received the actual vaccine, getting infected after receiving half the dose does not necessarily mean that the vaccine is not working.
Another important point regarding vaccines is that they don’t start working immediately after administered. In the case of Coronavirus vaccines, it takes a few weeks for the body to produce the T-lymphocytes and B-lymphocytes after vaccination. Therefore, even after getting both the doses, if a person comes in contact with the virus before the vaccine has protected the body, such a person will infected with the Chinese virus.
Phase 3 trials involving 28 thousand people have just begun and we must wait at least for interim analysis in those who received both the doses to conclude anything on the efficacy of the vaccine.
However, there is no need to panic about the efficacy of the Covaxin vaccine currently as it is yet to be known whether Anil Vij was subjected to an actual trial vaccine or a placebo, and he has received only one of the required two doses. Bharat Biotech is expected to make a statement soon in the light of recent developments.
