New Delhi (NVI): The Drugs Controller General of India (DCGI) has issued new guidelines focussing on safety, immunogenicity and efficacy parameters for pharma companies who are manufacturing COVID-19 vaccines.
According to the new guidelines, 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.
Furthermore, the pharma companies developing the vaccines must provide adequate data informing the potential risk of vaccine-associated Enhanced Respiratory Disease (ERD), the guideline said.
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.
Under the guidelines the DCGI has urged the pharma companies to present a final analysis plan before closing the trial database. “This should include any planned interim analyses, which should be adequately addressed in terms of purpose, timing, and any statistical adjustments required,” it stated.
“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.
Moreover, there are three things for a vaccine to develop—the safety, immunogenicity, and the efficacy, World Health Organization (WHO) guideline says that if we can get more than 50 per cent efficacy than it is an accepted vaccine.
“For respiratory viruses, we by no means get 100 per cent efficacy. We’re aiming for 100 per cent efficacy however might get 50-100 per cent,” said Balram Bhargava, Director-General, ICMR, while responding to a query on the efficacy of COVID-19 vaccine.