Covaxin, India’s first indigienous vaccine for the highly infectious coronavirus, has been designed to be effective if a person takes two doses, Hyderabad-based pharmaceutical firm Bharat Biotech clarified in a statement today, stressing that the “efficacy can be determined 14 days after the second dose”. The clarification came soon after Haryana Health Minister Anil Vij, who was a volunteer in the third phase of vaccine trials in his state, said he has tested positive for COVID-19. “Safety is our primary criteria in vaccine development,” the pharma firm assured.
“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,” the Hyderabad firm said in an official statement. One of the three Covid vaccine candidates being tested in India, Covaxin – in its third phase of trials- will be administered to “26,000 subjects across 25 sites”, the statement reads.
“The phase 3 trials are double blinded and randomised, where 50 per cent of subjects will receive vaccine and 50 per cent of subjects will receive placebo,” the firm underlines.
Earlier today, Anil Vij tweeted: “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.” He had earlier been administered a single trial dose of the vaccine.
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
In a statement, the Health Ministry said: “The antibodies 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. This is a two-dose vaccine. The minister in question has taken only one dose of the vaccine.”
Bharat Biotech is also conducting Covaxin clinical trials in the United States and the United Kingdom, it said today, adding that it has conducted more than 80 clinical trials, across 18 countries in the last 20 years.
“Bharat Biotech has supplied more than 4 billion doses, to more than 80 countries, with an excellent track report of safety, 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,” the firm underlines.
Last week, Prime Minister Narendra Modi visited the Hyderabad firm to personally review the development of Covaxin.
Yesterday, he said that experts are hopeful that India will get a vaccine in the next few weeks.
The country has logged over 96 lakh infections so far, the second-highest in the world after the United States.