Haryana Health Minister Anil Vij who participated in the phase III trials of Bharat Biotech coronavirus
Covaxin vaccine, has tested positive for COVID-19. “They tested positive for Corona. I am admitted to the Ambala Cantt Civil Hospital. All those who have been in close contact with me are advised to take the crown test, ”Vij tweeted on Sunday.
The development raised concerns about the performance of the trials and the efficacy of the vaccine. However, the union’s health ministry and Bharat Biotech were quick to point out that the efficacy of the vaccine would be determined after the volunteers received the full dose.
In the context of the Haryana minister’s tweet, the union health ministry issued a short comment on the ministry’s official WhatsApp group. “Antibodies against infection accumulate in a human being only after a specific number of days pass after the second dose of the vaccine is taken. Since this is a two dose (sic) vaccine. The minister in question has taken only one dose of the vaccine, “he said.
However, the response from the union health ministry to Vij’s tweet raised more questions. The phase III trial of Covaxin is designed as a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of the BBV152 or Covaxin vaccine. The phase III trial will be conducted at 25 centers and is likely to enroll 25,800 people.
In a randomized, double-blind trial, neither the volunteer nor the person giving the injection knows whether it is the real vaccine or the placebo. In the case of Covaxin, it is being compared to phosphate buffered saline with Alum (no antigen). Placebo will be administered in two doses as an intramuscular injection 28 days apart according to the Clinical Trials Registry India (CTRI).
The comment from the Ministry of Health that “the minister in question has taken only one dose of the vaccine” raises serious ethical issues surrounding the conduct of the crucial vaccine trial, which is being carried out in collaboration with the Council. Indian Medical Research.
The comment from the Ministry of Health indicates that the trial design has not been met. The trials are designed as randomized and double blind to ensure impartiality and to rule out any bias in both volunteers and dosers.
News18 reached out to Bharat Biotech seeking a response to the ministry’s comment revealing that the minister received an injection of the vaccine. The company chose not to offer any comment. However, it issued a blanket statement saying that Covaxin clinical trials are based on a two-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 statement said.
He added: “Phase III trials are double-blind and randomized, where 50% of the subjects will receive the vaccine and 50% of the subjects will receive placebo.”
The minister’s tweet made people nervous on social media, as many perceived it as an indication that the vaccine was ineffective. A volunteer can test positive midway through the test, as the viral load of infection is reflected by a positive test many days after infection.
Vij participated in the trial in an attempt to encourage citizens to participate as volunteers in the different ongoing clinical trials to test vaccines against COVID-19, the disease caused by the novel coronavirus infection. In a highly publicized affair, Vij had participated in the Phase III trials on November 20.
.
