According to the draft guidelines for the development of COVID-19 vaccines, a vaccine developed in India should prove that at least 50 percent of those administered with the vaccine are protected from the virus to get an approval.
For vaccines that are being developed outside India, the authorisation will be provided on the basis of clinical trial data once they pass evaluation for the overall safety and effectiveness of the vaccine.
“However, an 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,” the draft guidelines, released by Central Drugs Standard Control Organisation on September 21, read.
India’s vaccine guidelines are in line with recommendations made by the US Food and Drug Administration (FDA) and World Health Organisation (WHO).
The 40-page document titled ‘Draft Regulatory Guidelines For Development of Vaccines With Special Consideration For COVID-19 Vaccine’ has several safety protocols that companies have to follow while developing and manufacturing the Considering the urgent need of a safe and effective vaccine to contain the spread of coronavirus pandemic, Drugs Controller General of India has allowed clinical development programs of COVID-19 vaccine to proceed using adaptive and seamless approach.
While a seamless design combines two separate trials (individual Phase 2 and Phase 3 trials) into one trial, an adaptive seamless design makes use of information (data) from patients enrolled before and after adaptation (pulls together data collected in both the Phase 2 and Phase 3 trials) in the final analysis.
“However, regardless of whether clinical development of COVID-19 vaccine proceeds with separate studies or via a seamless approach, adequate data, including data to inform the potential risk of vaccine-associated Enhanced Respiratory Disease, will be needed,” as per the draft framework.
Noting that the understanding of SARS-CoV-2 immunology is currently evolving, the CDSCO said that the predictive value of the immune response for short-term and/or longer-term protection from SARS-CoV-2 infection and/or disease may be investigated.
“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.
CDSCO has sought comments on the draft framework till October 12.