Two weeks after taking the first dose as part of the trials for Bharat Biotech’s Covaxin vaccine, Haryana Health Minister Anil Vij, 67, announced on Saturday that he was hospitalised after testing positive for the coronavirus.
Vij was the first volunteer for the Covaxin Phase III human trials in Haryana, as part of which around 600 people in the state and over 25,000 across the country are enrolled — half of them receiving a placebo as part of the “double blind” study. The Union Health Ministry as well as officials conducting the trials in the state said Vij’s infection could not be attributed to the vaccine, as even if he was among the volunteers who got the vaccine, it was only the first of two doses, and sufficient antibodies only develop after the second.
A diabetic, Vij recently underwent a surgery after fracturing his thigh bone. Health Department officials who visited him told The Sunday Express his parameters were fine. Vij told PTI from hospital, “I was told that antibodies start to develop after the second dose, which is administered after 28 days of the first shot. And full antibodies develop 14 days after the second dose. So, the complete cycle takes 42 days. In between there is no protection.”
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The Union Ministry of Health & Family Welfare said, “The antibodies against the infection build up in a human being only after a specific number of days pass after the second dose.”
Two-dose vaccine candidate
Covaxin is meant to be taken over two doses, and on November 20, Anil Vij received the first shot (with a 50% chance of it having been a placebo). Both the government and Bharat Biotech said antibodies were meant to develop only two weeks after the second dose, with the whole process spread over 42 days.
Bharat Biotech also said that the vaccine efficacy could be determined only after the second dose, and reiterated that volunteers had a 50 per cent chance of having got the placebo. “Covaxin has been designed to be protective two weeks after volunteers receive the second dose,” the company said, adding, “All volunteers have been advised to follow the guidelines for prevention of Covid-19 set by the Ministry of Health.”
Savita Verma, the principal investigator of the team formed to conduct the vaccine trials in Haryana, said, “Mr Anil Vij was given the first dose on November 20. He was supposed to be given the second dose on December 18. Fourteen days after the second dose, adequate amounts of antibodies are formed in the subject’s body. It is pertinent to mention that Mr Vij has not got Covid due to this vaccine/placebo. In the entire country, 25,800 persons are to be administered this trial vaccine in the third phase… Nobody knows if a volunteer has got a placebo or a vaccine… The first and second phases have been extremely successful… No major side effects have come to light so far.” Verma went on to caution, “I would like to appeal to all the volunteers that till 42 days after the first dose, there is always a danger of infection.”
Vij had got the shot on November 20 from a Rohtak PGIMS team, and his health and vitals were being monitored since. He had been attending office at the Haryana Civil Secretariat, as well as meeting people at his residence. He told PTI he was fine except for a sore throat, body ache and fever.
After getting the shot, Vij had said, “The first two phases of the trials were for restricted categories. But, this third phase is open for even high-risk category people. I did not fear for even a minute… Doctors will monitor my health for one year.” He had also hoped that his step would encourage others to come forward to volunteer.
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