New Delhi/Hyderabad: Covaxin is a two-dose anti-coronavirus vaccine and Haryana Health minister Anil Vij, who had volunteered for its phase-three trial, was given only the first dose, the Union Health Ministry and the city-based Bharat Biotech clarified on Saturday hours after the Minister announced that he has tested positive for Covid-19.
Vij had offered to be the first volunteer in the phase three trials for Covaxin, an indigenous potential vaccine against Covid-19 being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). On Saturday, the Union 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.”
The Haryana Health Minister too said antibodies start to develop after administration of the second dose, which is given 28 days after the first shot, and there is no protection during this period. The 67-year-old minister was given the first shot on November 20. Stressing that experts would know better about how the COVID-19 vaccine works, Vij told PTI over phone: “I was told that antibodies start to develop after the second dose, which is administered after 28 days of getting the first shot. And full antibodies are developed 14 days after the second dose is given. So, the complete cycle takes 42 days. In between there is no protection.” Asked about his condition, Vij said he has sore throat, fever and body ache. “But overall I am okay,” he said.
In a statement, Bharat Bitech said: “Covaxin is a fully indigenously developed Covid vaccine, with the largest phase three clinical trial conducted in India in 26,000 subjects across 25 sites. The goal is to evaluate the efficacy of Covaxin across India.
The company said that the phase three trials are double blinded and randomised, where 50 per cent subjects receive vaccine and the balance placebo. “The phase three trials of Covaxin is the only efficacy trial being conducted in India for Covid vaccines to determine its suitability to the diverse Indian population,” the company added.
Bharat Biotech stated it is an innovator, vaccine developer and manufacturer and safety of vaccines is its primary objective, followed by efficacy.
According to the company, it has conducted more than 80 clinical trials in its two-decade history across 18 countries on almost 6 lakh subjects.
“The same reporting procedure is followed for all clinical trials. All clinical trials are conducted in compliance with good clinical practices,” the statement highlighted.
It added that the vero cell manufacturing platform used for Covaxin has delivered more than 300 million doses till date with a good safety track record.