India may approve Covid-19 vaccine that will show 50% efficiency
The Indian drug regulator has said it plans to approve COVID-19 vaccines that can provide immunity to at least 50% of the participants in phase 3 clinical trials.
With rules and regulations set by the World Health Organization and the US(United States) Food and Drug Administration. The Indian drug regulator has taken this decision.
On Monday at a virtual press conference WHO chief scientist Soumya Swaminathan stated that “Mainly 70% efficancy and above, but certainly 50% would be the percentage 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 and the low boundary of efficacy adjusted for confidence interval is 30%
“To ensure that COVID-19 vaccine is effective, the primary efficancy percentage for a placebo-controlled efficacy trial should be at least 50%,” The CDSCO (Central Drugs Standard Control Organization)said in its draft regulatory guidelines for vaccine development, with special consideration for covid-19 vaccine issued on Monday
According to regulator various potential primary and secondary endpoints for the vaccine to target, which are goals for measuring success of the study.
And The CDSCO has also regulated the same benchmark of 30% as the lower boundary of efficacy after accounting for confidence interval. Confidence intervals look at the probability of error in efficacy rate. It is also dependent on the size of the clinical trial.
“SARS-CoV-2 infection ( symptomatic or asymptomatic) should be evaluated as a secondary or exploratory endpoint, if not evaluated as a primary endpoint,” the regulator said.
And Indian regulator has also cleared that people who have been infected with Covid-19 earlier should be allowed to participate in trials as long as they did not have acute Covid-19 or other acute infectious illnesses.
The regulator also said in the draft that Vaccine safety and COVID-19 outcomes in individuals with prior SARS-CoV-2 infection, which might have been asymptomatic, is also important to examine because pre-vaccination screening for prior infection may not be feasible in practice when the COVID-19 vaccine is approved and introduced in the market.
There are three vaccines undergoing human trials, with another vaccines in pre-clinical trials.
The furthest of these vaccines in human trials are Serum Institute of India’s vaccines, which was jointly developed by AstraZeneca plc and University of Oxford and is currently undergoing phase 2 and 3 trials in India.
The other two vaccines in human trials are Zydus Cadila’s and Bharat Biotech International’s.
Soon “SputnikV” vaccine Phase 3 trial will also start in India.
After appealing by vaccine manufacturers to CDSCO that India needs to have its own benchmarks for approving vaccines, something that had not been made clear so far these draft regulations was introduced for Indian Manufacturers.
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