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 given conditional accelerated approval to AstraZeneca partner Serum Institute, and separately to Bharat Biotech, for their COVID-19 vaccines. With the latter’s candidate still in Phase III trials, the unprecedented decision has caused controversy given the national regulator had earlier said an EUA would not be granted unless trials are completed.
India gave a conditional accelerated approval to AstraZeneca partner Serum Institute and separately, to Bharat Biotech for their COVID-19 vaccines. With the latter’s vaccine still in Phase III trials, the unprecedented decision caused a flutter as the regulator had earlier said an EUA would not be granted unless trials are completed.
With seven COVID-19 treatment/prophylactic candidates lined up, India's Zydus Cadila is unleashing all it can to combat the disease. Meanwhile, the firm has also offered an update on the state of its injectables and transdermals business in the US, which is contingent on resolving deficiencies at its Moraiya plant.