Consent, AEFI follow-up to discontinue as Covaxin taken off clinical trial mode

New Delhi, March 11 : After the Drugs Controller General of India (DCGI) amended the licensure of Bharat Biotech’s Covaxin from clinical trial mode emergency use authorisation based on the recommendation of its Subject Expert Committee, the Centre has ceased the mandatory conditionalities of taking consent and follow-up of AEFI (adverse event following immunisation) post the first and second dose administration of the vaccine among its beneficiaries.
The National Health Mission (NHM) has apprised all the states and Union Territories (UTs) about the development in the status of Covaxin and the termination of prior conditions in accordance to its authorisation.
The Covaxin, which was earlier licensed for “restricted use in emergency situation in public interest use as an abundant precaution, in clinical trial mode”, has now been amended for “restricted use in emergency situation in public interest”, said the letter addressed to NHM state directors, principal and health secretaries of states and the immunisation officers.
“I would like to inform you that based on the recommendations of the Subject Expert Committee (SEC), the condition ‘This permission is for restricted use in emergency situation in public interest use as an abundant precaution, in clinical trial mode’ as mentioned in the said permission of DCGI is amended to read as ‘This permission is for restricted use in emergency situation in public interest’,” the letter issued by Manohar Agnani, Additional Secretary, NHM, read.
“Hence, the vaccine recipients are now not required to read the fact sheet, sign the consent forms and submit AEFI reports to the Covid vaccination centres 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 within,” it said.
One day back, the Subject Expert Committee had approved Covaxin for emergency use authorisation.