According to the protocol, Bharat Biotech has not disclosed whether Haryana’s Health Minister Anil Vij received the dose of the vaccine or the placebo.
Hyderabad-based Bharat Biotech, which is developing the indigenous COVID-19 Covaxin vaccine, issued a statement on Saturday after Haryana Health Minister Anil Vij, who had participated in the phase 3 clinical trials, tested positive. by coronavirus. After questions were raised about the efficacy of the candidate vaccine, Bharath Biotech said that for the vaccine to work, it must be taken in two doses, and the efficacy of the vaccine can only be known two weeks after the second dose, which is administered 28 days after the first dose.
Bharat Biotech also stated that it is conducting a double-blind study, which means that both participants and administrators know whether the individual is receiving the actual vaccine or a placebo. A placebo is an injection that looks identical to the treatment given in a clinical trial, but is not.
Anil Vij, the Haryana Minister of Health, participated in the vaccine trial on November 20, as part of the Phase 3 clinical trials. He was administered one dose, but according to protocol, Bharat Biotech has not specified whether the Minister received the dose of the vaccine or the placebo.
Bharath Biotech has stated that Covaxin volunteers only have a 50% chance of receiving the vaccine or a placebo in phase 3 trials. The company added that Covaxin is designed to protect two weeks after the volunteers receive the second dose. . The pharmaceutical company has added that according to the norm, they have advised all their volunteers to continue following the COVID-19 prevention guidelines established by the Ministry of Health and Family Welfare of the Union.
The company issued the statement after Anil Vij tested positive for the coronavirus on December 5, days after taking part in the trial, sparking a storm of tweets in which many questioned the efficacy of the vaccine. However, as this is a double-blind study, the minister has no way of knowing whether he has injected a vaccine or a placebo.
Emphasizing that experts would know better how the COVID-19 vaccine works, Vij told PTI by phone: “They told me that antibodies start to develop after the second dose, which is given 28 days after receiving the first injection. Antibodies develop 14 days after the second dose is given. Therefore, the entire cycle lasts 42 days. In the meantime, there is no protection. “
After media reports that Vij tested positive, the Health Ministry issued a statement to the media: “Antibodies against infection accumulate in a human being only after a specified number of days after the drug is taken. Second dose of the vaccine. It is a two dose vaccine. The minister in question has taken only one dose of the vaccine. “
Bharath Biotech had started phase 3 clinical trials on November 16, and at the time the company’s president and managing director, Krishna Ella, had said that the company was trying to make the vaccine in single-dose nasal spray form. . The executive director had raised concerns about the possibility of distributing a two-drop injectable vaccine that requires cold storage to 1.3 billion people. The company noted that more than 2.6 billion doses will have to be developed if the vaccine is in its 2-dose form.
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