CHENNAI: From now on the recipients of Covaxin need not sign a consent form before taking the shot against Covid-19 as the Drug Controller General of India has removed the "in clinical trial mode" tag for the vaccine.
This comes after interim results from the Phase 3 trials showed that Covaxin, produced by Bharat Biotech, has an efficacy of 81 per cent efficacy on taking the second dose of the vaccine.
In a letter to all State Health Secretaries on Thursday, the Union Health Ministry said, “The vaccine recipients are not required to read the fact sheet, sign the consent forms and submit the Adverse Event Form to Covid Vaccination Centre before the second dose and after seven days of the second dose, as was required earlier. All these conditionalities are no longer to be complied with."
Covaxin was earlier conditionally approved by the DCGI. “This permission is for restricted use in emergency situation in public interest use as an abundant precaution, in clinical trial mode," the drug controller had said. As a result, people taking the vaccine were required to read a fact sheet, sign a consent form etc before being administered the vaccine.
After the interim results of the Phase 3 trial were released the DCGI, based on Subject Expert Committee (SEC) recommendations, amended the approval to state, “This permission is for restricted use in emergency situation in public interest,” after removing the “in clinical trial mode” tag.