Coronavirus vaccine: How efficient a Covid-19 vaccine has to be to get approval in India

Coronavirus Vaccine update: An experimental Covid-19 vaccine candidate needs to show at least 50 per cent efficacy during the human trials to get approval in India. India’s national regulatory body for pharmaceuticals and medical devices, Central Drugs Standard Control Organisation (CDSCO), will only approve Coronavirus vaccine candidates which will meet the crucial parameters of 50 per cent efficacy during the clinical trials, experts were quoted as saying by Indian Express.

This means that the CDSCO wants to ensure that the Coronavirus vaccine has the capacity to improve the condition in 50 per cent of people, who are vaccinated with COVID-19 vaccine against the same number of the population who did not get vaccinated.

The CDSCO has released a new set of guidelines for Coronavirus vaccines on Monday. The guidelines underlined that the statistical range of efficacy of a potential Coronavirus candidate in the clinical trials or human trials must not be lower than 30 per cent. The CDSCO’s guidelines came months after the World Health Organization (WHO) and the US Food and Drug Administration (FDA) had unveiled their own set of norms for Covid-19 vaccine approvals.

The CDSCO guidelines read “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 percent, and the statistical success criterion should be that the lower bound of the appropriately alpha-adjusted confidence interval around the primary efficacy endpoint point estimate is (greater than) 30 percent.”

“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,” the CDSCO guidelines stated. “Therefore, subjects with history or laboratory evidence of prior COVID-19 infection should not be excluded from the COVID-19 vaccine trial,” it added.

The CDSCO guidelines suggested that the size of the human trial of any Coronavirus vaccine candidate must be sufficient so that if the reviewers get exactly 50 percent efficacy then they should be confident that it won’t be less than 30 per cent, vaccine scientist and Christian Medical College, Vellore professor Dr Gagandeep Kang was quoted as saying by IE. Kang has claimed that the CDSCO guidelines are “an amalgamation” of norms set by the WHO and US FDA.

VK Paul, Member (Health), Niti Aayog, has said that the ‘first’ aim of a Coronavirus vaccine in India to reduce the mortality rate in the vulnerable population. Paul chairs the National Expert Group on Vaccine Administration for Covid-19.