Companies seeking regulatory approval for their Covid-19 vaccines would have to show the required response in at least 50 per cent of those vaccinated during human testing, India’s top drug regulator has said.
“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 per cent, 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 per cent,” said the Central Drugs Standard Control Organisation (CDSCO) in a set of draft regulatory guidelines for Covid-19 vaccines.
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 regulator has also clarified that persons who have been infected with the SARS-CoV-2 virus in the past should be included in vaccine testing, as long as they do 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,” stated the 40-page draft.
“Therefore, subjects with history or laboratory evidence of prior COVID-19 infection should not be excluded from COVID-19 vaccine trial,” it added.
The draft suggests that it may be easier for globally tested candidates like the AstraZeneca-University of Oxford and Russia’s Sputnik V vaccine to receive approvals here on the basis of testing data generated in other countries. An additional local trial “may” be required.
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“In case, a vaccine has been developed and has undergone clinical trial development outside India and marketing authorization application for the same have 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, additional clinical trial may be required in the local population to confirm the safety and effectiveness in 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.
The guidelines come several months after the World Health Organisation (WHO) and the US Food and Drug Administration (US FDA) released their own guidelines for Covid-19 vaccine approvals and draw from both documents, according to experts that have been closely tracking and involved in Covid-19 vaccine developments.
The guidelines are aimed at offering more clarity to vaccine firms that have been in the dark about India’s requirements where Covid-19 vaccines are concerned.
In early August, three vaccine firms raised the ambiguity in guidelines for Covid-19 vaccines, including their level of efficacy, during a panel discussion in Hyderabad.
“This is really important, because then you measure every vaccine with the same yardstick and then you ensure safety, so I think we immediately need those guidelines to be put in place. Because manufacturers have a goal–is it immunogenicity, is it a four-fold increase or do you expect efficacy?…what is that need is not being made clear,” said Mahima Datla, Managing Director, Biological E at that time.
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