Aditi tandon
Tribune News Service
New Delhi, December 5
The government clarified on Saturday that Haryana Health Minister Anil Vij’s positive COVID status was not a comment on the efficacy of COVAXIN, the indigenous COVID vaccine being developed by Bharat Biotech and ICMR, as the vaccine trial It is a two dose regimen and Vij has only been given one injection yet.
Read also: Days after receiving the vaccine, Haryana Health Minister Anil Vij tests positive for Covid
COVAXIN is just one of two indigenous COVID vaccines in the final phase of phase 3 human trials in India, the other being the candidate for Zydus Cadila.
The COVAXIN trial results evaluated by the Indian drug regulator so far have shown that it is effective enough to move from phase 2 (trials in a limited number of people) to phase 3, which includes multicenter trials in large populations.
Regarding this news:
“Antibodies against infection build up in a human only after a specific number of days 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, ”said an official from the Ministry of Health.
Bharat Biotech also developed the study design and said that COVAXIN has been designed to be effective.
“The COVAXIN clinical trials are based on a 2-dose schedule, 28 days apart. The efficacy of the vaccine will be determined 14 days after the second dose.
COVAXIN has been designed to be effective when subjects receive both doses and after the 14-day period after the second dose, ”the company said.
Phase 3 trials are double-blind and randomized, where 50 percent of the subjects will receive the vaccine and 50 percent of the 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 used to avoid bias in the research results.
COVAXIN is a fully indigenous COVID-19 vaccine, with the largest phase 3 clinical trial conducted in India, on 26,000 subjects at 25 sites.
The aim is to evaluate the efficacy of COVAXIN throughout India.
COVAXIN Phase 3 Trials is the only efficacy trial being conducted in India for COVID-19 vaccines, to determine their suitability for the diverse Indian population.
The infection status does not determine the efficacy of the vaccine: head of the ICMR
Meanwhile, the ICMR said that an individual’s infection status does not determine the efficacy of the COVID vaccine.
ICMR is collaborating with Bharat Biotech on COVAXIN, the indigenous COVID 19 vaccine from India.
Speaking to The Tribune on the matter today, ICMR chief Balram Bhargava said: “The participation of political leaders in the vaccine trial helps to dispel fear from people’s minds related to such participation.
“Anyone, whether it’s the vaccine arm or the placebo arm, can get the infection.”
Bhargava said the final analysis would reveal whether the vaccination arm had a significantly lower infection rate among participants compared to the placebo arm, resulting in an estimate of the efficacy of the vaccine, which is not 100%. in no vaccine.
“The infection status of an individual does not determine the efficacy of the vaccine at the population level,” he said.
COVAXIN in a double-blind trial in which half of the participants received the vaccine and the other half received the placebo, with neither the recipient nor the experimenter knowing who was receiving what.
