First study results
In an adaptive, multicenter, randomized, double-blind, placebo-controlled phase I / II dose escalation study in over 1,000 healthy adult volunteers (CTRI / 2020/07/026352), ZyCov-D had already been shown to be safe and triggered a strong immunogenic response. The emergency approval is now based on interim results of a randomized, multicenter, double-blind, placebo-controlled phase III study (CTRI / 2021/01/030416), which is being carried out in India with around 28,000 participants at over 50 centers. The data come from the second corona wave, when the new mutated strains, especially the Delta variant, were already predominant there. 1,000 subjects belonged to the youthful population between the ages of twelve and 18 years. In the interim analysis, a primary effectiveness of 67 percent in preventing symptomatic RT-PCR positive cases was achieved. Of 81 symptomatic infections, 21 occurred in the vaccine and 60 in the placebo group. The vaccine should be able to prevent moderate COVID-19 diseases 100 percent. In addition, there were no severe cases or deaths from COVID-19 after the second dose of vaccine was administered. ZyCov-D’s safety profile was also good in adolescents between the ages of twelve and 18. The company plans to test the vaccine on five to twelve year olds soon. At the end of April, Zydus Cadila started production of ZyCoV-D with an annual capacity of 240 million cans. Up to 50 million vaccine doses are to be made available by the beginning of 2022. Approval in other countries is not yet in sight.