CDSCO plans to approve Covid-19 vaccines showing 50 percent efficacy in clinical trial

"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," the draft stated.

The draft regulations came after several calls by vaccine manufacturers that India needs to have its own benchmarks for approving vaccines, something that had not been made clear so far.

It is aimed at offering more clarity to vaccine firms that have been in the dark about India's requirements where Covid-19 vaccines are concerned.

The regulator has listed out various potential "primary" endpoints — the primary goal or outcome of the vaccine — for the vaccine to target. "SARS-CoV-2 infection (whether or not symptomatic) should be evaluated as a secondary or exploratory endpoint, if not evaluated as a primary endpoint," stated the draft.

The Indian regulator has also clarified that people who have been infected with the novel coronavirus, SARS-CoV-2, earlier should be allowed to participate in trials as long as they did not have acute Covid-19 or other acute infectious illnesses.

"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 regulator said in the draft.

"Once the vaccine is approved for marketing, the direct evidence of vaccine efficacy in protection from SARS-CoV-2 infection must be accessed through appropriate study in Post Marketing Scenario," the guidelines said, adding that clinical development programs for COVID-19 vaccines might be expedited for more rapid progression.

For vaccines that are being developed outside India, the authorization will be provided on the basis of clinical trial data once they pass the evaluation for the overall safety and effectiveness of the vaccine.

"In case, a vaccine has been developed and has undergone clinical trial development outside India and marketing authorization application for the same has been submitted to CDSCO, the clinical data generated will be considered for evaluation of overall safety and effectiveness of the vaccine," stated the draft.

"However, an additional clinical trial may be required in the local population to confirm the safety and effectiveness of the Indian population. The extent of local clinical trial requirements will be decided on a case by case basis considering the urgency, unmet need of the vaccine in the country," it added.

CDSCO has sought comments on the draft framework till October 12.

India's vaccine guidelines are in line with recommendations made by the US Food and Drug Administration (FDA) and World Health Organisation (WHO).

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