The Indian Drug regulator has said that it is planning to permit COVID-19 vaccines which can boost immunity to at least 50 per-cent of the participants in phase 3 clinical trials.
The CDSCO mentioned in its draft regulatory guidelines for vaccine development, keeping in mind the COVID-19 vaccine issued on Monday, “To ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%.”
The benchmarks drafted by the Indian Drug Regulator are sane as set by the WHO in April and US FDA June.
“Ideally 70% efficacy and above, but certainly 50% would be the point estimate that we would classify as an effective vaccine. It is also important how these endpoints are studied in clinical trials, because as you know around the point estimate you have confidence interval. So it is also important that the confidence intervals are not too wide,” WHO chief scientist Soumya Swaminathan said on Monday at a virtual press conference, adding that the low boundary of efficacy adjusted for confidence interval is 30%.
The same benchmark of 30 per-cent has also been said by the CDSCO. The probability of error in the efficacy rate is looked by the Confidence intervals. Confidence intervals also depend on the clinical trial’s size.
The regulator has cited various potential primary and secondary endpoints for the vaccine to target, which are goals for measuring success of the study.
“SARS-CoV-2 infection (whether or not symptomatic) should be evaluated as a secondary or exploratory endpoint, if not evaluated as a primary endpoint,” the regulator said.
The drafted regulator also cites that people who have been infected with SARS-CoV-2 earlier, allowed to take part in trials if they do not have acute Covid-19 or other acute infectious illnesses.
Several Indian vaccine manufacturers had demanded that India should have its own benchmarks for vaccines approval. This draft regulation came in the light of those calls made. Presently, 3 vaccines are undergoing human trials and another half a dozen vaccines are in pre-clinical trials.