AstraZeneca says US data load for US Covid-19 vaccine approval very big – Times of India

AstraZeneca says US data load for US Covid-19 vaccine approval very big – Times of India


LONDON: AstraZeneca is working as fast as possible to compile data on its Covid-19 vaccine to apply for US approval but the dataset is very big, executives said on Friday as the drugmaker faces delays to its submission.
“There’s a lot more data than just a Phase III study and so we’re working as fast as we can to pull it all together and submit,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca.
Chief executive Pascal Soriot said in a briefing following the release of first-quarter results there was nothing wrong with the data, but the dataset was very big.
On Friday, the company said it planned to apply for US approval in the coming weeks. That is a delay from late March when the company also said it would submit the data in the coming weeks.
Soriot said the company still expected to hit output of 200 million doses of the vaccine this month.



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