Hyderabad: The administration of 55 lakh doses of Covaxin, the Bharat Biotech vaccine ordered by the Centre as part of the Covid-19 vaccination drive, could well mean that a massive government-mandated trial is underway for the vaccine that is yet to officially complete its Phase III trials.
When its “emergency use” was approved by the government, it was done under “clinical trial mode”. What this meant became evident on Saturday when those receiving the vaccine in several states according to media reports, were asked to sign a consent form agreeing to be part of such a clinical trial.
In the consent form, Bharat Biotech says the vaccine is being offered in a clinical trial mode and that in Phase I and II of the trials the vaccine demonstrated ability to produce antibodies to Covid-19. “However, the clinical efficacy is yet to be established and it is still being studied in phase 3 clinical trial,” the form read.
Telangana state Director of Health Services…
