Following a nod from Drug Controller General of India (DCGI) Bharat Biotech’s Covaxin has been taken off from its clinical trial mode status. With this, the Union government 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 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.
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.
"I would like to inform you that based on the recommendations of the Subject Expert Committee (SEC), the condition stating that the’ permission is for restricted use in emergency situation in public interest use as an abundant precaution, in clinical trial mode' is amended to read as ‘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.
Earlier, the vaccine's emergency use was permitted only in the clinical trial mode. This condition has now been waived off by the Drug Controller General of India (DCGI).
The decision was taken after the expert panel studied the interim results of the Phase 3 trials of the vaccine which demonstrated 81% efficacy.
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