No EUA For COVID-19 Vaccines Prior To Trials Completion, Says India
Russia To Conduct Phase III Trials In India
The Indian regulator says it is not considering emergency use authorization for COVID-19 vaccines before completion of clinical trials, a stand validated by AstraZeneca halting trials of its vaccine candidate due to an adverse event in UK. Meanwhile, India has signed up for Phase III trials of Russia’s vaccine candidate
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India has rolled out draft guidelines for development of vaccines with special focus on COVID-19 vaccines, drawing from those of other regulatory bodies and the WHO. Experts suggest the primary efficacy endpoint of minimum 50% is acceptable given that vaccines against respiratory diseases are difficult to develop though not necessarily enough to snuff out a pandemic.
The move reduces the pressure on the companies to rush development, but also relieves burden on the FDA to approve a candidate too soon.
CEOs from the most advanced vaccines developers pledge to maintain standards – for the sake of safety, efficacy and public trust in vaccines.