Updated: September 22, 2020 9:16:07 pm
Ambulances are delivered to the Karnataka government by a private entertainment outlet to help fight the Covid-19 pandemic, in Bangalore on Tuesday, September 15, 2020. (PTI Photo: Shailendra Bhojak)
Companies seeking regulatory approval for their Covid-19 vaccines would have to show the required response in at least 50 percent of those vaccinated during human trials, India’s top drug regulator said.
“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%, and the statistical success criterion must be that the lower limit of the appropriate alpha – The adjusted confidence interval around the estimate of the main efficacy end point is (greater than) 30 percent, ”said the Central Drug Standard Control Organization (CDSCO) in a set of preliminary regulatory guidelines for Covid-19 vaccines.
The regulator has listed several potential “primary” endpoints – the primary target 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,” the draft states.
The regulator has also clarified that people who have been infected with the SARS-CoV-2 virus in the past should be included in vaccine tests, as long as they do not have acute Covid-19 or other acute infectious diseases.
“It is also important to examine the vaccine safety and COVID-19 results in people with previous SARS-CoV-2 infection, who may have been asymptomatic, because pre-vaccination screening for previous infections may not be feasible in the practice when the COVID-19 vaccine is approved and placed on the market, ”states the 40-page draft.
“Therefore, subjects with a history or laboratory evidence of a previous COVID-19 infection should not be excluded from the COVID-19 vaccine trial,” he added.
The draft suggests that it may be easier for globally tested candidates like the AstraZeneca-University of Oxford vaccine and Russia’s Sputnik V vaccine to receive approvals here based on test data generated in other countries. Additional local “can” test is required.
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“In case a vaccine has been developed and a clinical trial has been developed outside of India and a marketing authorization application for it has been submitted to CDSCO, the clinical data generated will be considered for safety assessment and overall efficacy of the vaccine, “the project stated.
“However, additional clinical trials in the local population may be required to confirm safety and efficacy in the Indian population. The scope of local clinical trial requirements will be decided on a case-by-case basis, taking into account the urgency and unmet need for the vaccine in the country, ”he added.
The guidelines come several months after the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA) published their own guidelines for Covid-19 vaccine approvals and are based on both documents, according to experts who have been closely following and involved in the development of the Covid-19 vaccine.
The guidelines are intended to offer more clarity to vaccine companies that have not been aware of India’s requirements when it comes to Covid-19 vaccines.
In early August, three vaccine companies raised the ambiguity in the guidelines for Covid-19 vaccines, including their level of efficacy, during a panel discussion in Hyderabad.
“This is really important, because then all vaccines are measured with the same criteria and then safety is guaranteed, so I think we need those guidelines to be implemented right away. Because manufacturers have one goal: is it immunogenicity, is it quadrupled, or is efficacy expected? … what is that need that is not clear, ”said Mahima Datla, managing director of Biological E at the time.
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