A Central Drugs Standard Control Organisation (CDSCO) panel has rejected Zydus’ request for a phase III clinical trial (CT) waiver for their proposed COVID-19 vaccine. The decision was based on the panel’s findings that the available data on the vaccine’s efficacy and safety were insufficient.
The CDSCO panel reviewed the company’s application, which included data from phase I and II trials, as well as animal studies. However, the panel felt that the data did not provide adequate evidence of the vaccine’s efficacy and safety in humans. Specifically, the panel noted that the phase II trial had a small sample size and was not adequately powered to determine the vaccine’s efficacy.
The panel also raised concerns about the vaccine’s safety profile, citing a lack of long-term follow-up data and inadequate reporting of adverse events. Additionally, the panel noted that the company had not provided sufficient data on the vaccine’s immunogenicity, which is the ability of the vaccine to induce an immune response.
The CDSCO panel’s decision is a setback for Zydus, which had hoped to accelerate the development of its COVID-19 vaccine. The company will now need to conduct a phase III clinical trial, which will require a larger sample size and more comprehensive data on the vaccine’s efficacy and safety.
The rejection of Zydus’ waiver request highlights the importance of rigorous clinical trials in ensuring the safety and efficacy of COVID-19 vaccines. The Indian government has been pushing for the rapid development of indigenous COVID-19 vaccines, but the CDSCO panel’s decision demonstrates that regulatory agencies will prioritize the safety and efficacy of these vaccines over haste.
The CDSCO panel’s decision also underscores the challenges faced by Indian pharmaceutical companies in developing COVID-19 vaccines. While several Indian companies have announced plans to develop COVID-19 vaccines, few have progressed to advanced stages of clinical trials. The rejection of Zydus’ waiver request serves as a reminder that the development of COVID-19 vaccines is a complex and time-consuming process that requires careful evaluation of efficacy and safety data.