On the lines of the World Health Organization (WHO) and the US Food and Drug Administration (US FDA), the Drugs Controller General of India (DCGI) has issued a new set of guidelines for Covid-19 vaccine candidates, focussing on safety, immunogenicity and efficacy parameters.
According to the guideline, a Covid-19 vaccine candidate should have at least 50 per cent of efficacy in the Phase-3 clinical trial for it to be widely deployed. Additionally, the pharma companies developing the vaccines must provide adequate data informing the potential risk of vaccine-associated Enhanced Respiratory Disease (ERD).
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DCGI has also asked the pharma companies to keep pregnant women and women of childbearing potential in mind as they are developing the vaccines. Safety assessments throughout clinical development and all pregnancies in study participants for which the date of conception is prior to vaccination or within 30 days after vaccination should be followed for pregnancy outcomes, including pregnancy loss, stillbirth, and congenital anomalies, it said.
Fifty per cent efficacy is a global standard as WHO, in its guidelines, mentioned 50 per cent efficacy fro a vaccine to be accepted and pharma giants like Astrazeneca, too, in its trial blueprint asserted that the company is working towards a vaccine with 50 per cent efficacy. “For respiratory viruses, we never get 100 per cent efficacy. We are aiming for 100 per cent efficacy but may get 50-100 per cent,” Dr Balram Bhargava, ICMR, Director-General said.
The DCGI has also asked pharma companies to present a final analysis plan before closing the trail database. “This should include any planned interim analyses, which should be adequately addressed in terms of purpose, timing, and any statistical adjustments required,” the guideline said.
“If a trial fails to meet the predefined criteria for superiority and/or non-inferiority with respect to any of the antigenic components, the possible reasons for the result and the clinical implications of it should be carefully considered before proceeding with clinical development or licensure,” DCGI said.
(With ANI inputs)
