NEW DELHI: Taking as a reference the benchmarks set by the World Health Organization and the US Food and Drug Administration, India’s drug regulator has said that it plans to approve the covid-19 vaccines that can provide immunity to at least 50% of the participants in phase 3 clinical trials.
“To ensure that a widely implemented COVID-19 vaccine is effective, the primary efficacy endpoint estimate for a placebo-controlled efficacy trial must be at least 50%,” said the Central Organization for Standard Control of Medicines ( CDSCO) in their draft regulatory guidelines. for vaccine development, with special consideration for the covid-19 vaccine issued on Monday.
The preliminary CDSCO benchmarks are the same as those set by the WHO and the US FDA in April and June, respectively.
“Ideally an efficacy of 70% or more, but certainly 50% would be the point estimate that we would classify as an effective vaccine. How these endpoints are studied in clinical trials is also important because, as you know, around the point estimate you have a confidence interval. So it is also important that the confidence intervals are not too wide, “WHO chief scientist Soumya Swaminathan told a virtual news conference on Monday, adding that the interval-adjusted low limit of efficacy confidence is 30%.
The CDSCO has also cited the same 30% benchmark as the lower limit of efficacy after taking into account the confidence interval. Confidence intervals analyze the probability of error in the efficacy rate. It also depends on the size of the clinical trial.
The regulator has cited several potential primary and secondary end points for the vaccine to target, which are targets for measuring the success of the study.
“SARS-CoV-2 infection (whether symptomatic or not) should be evaluated as a secondary or exploratory endpoint, if not evaluated as a primary endpoint,” the regulator said.
The Indian regulator has also clarified that people who have been infected with the new coronavirus, SARS-CoV-2, must first be able to participate in the trials as long as they do not have acute Covid-19 or other acute infectious diseases.
“It is also important to examine vaccine safety and COVID-19 results in people with prior SARS-CoV-2 infection, which may have been asymptomatic, because pre-vaccination screening for a prior infection may not be feasible. in practice when the COVID-19 vaccine is approved and placed on the market, “the regulator said in the draft.
The draft regulations come after several calls from vaccine manufacturers that India needs to have its own benchmarks to approve vaccines, something that has not been clarified until now.
Currently, there are three vaccines in human trials, with a further half a dozen vaccines in preclinical trials. The most advanced of these vaccines in human trials are the Serum Institute of India vaccines, which were jointly developed by AstraZeneca plc and the University of Oxford and are currently in phase 2 and 3 trials in India. The other two vaccines in human trials are Zydus Cadila and Bharat Biotech International.
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