AstraZeneca to Seek Approval for its Covid-19 Vaccine from US FDA


On 29th July 2021, AstraZeneca, a vaccine producing company said, it has now been planning to seek the approval of the US FDA for AstraZeneca’s covid-19 vaccine by end of 2021, and the company ‘AstraZeneca’ has also announced that, it had already delivered more than 1-billion doses of its vaccine to number of other countries across the world.

The company said, the application had been delayed because the company has decided for asking the United States Food and Drug Administration (FDA) for the complete approval from the regulatory, other than the emergency use authorization, which was originally anticipated.

As being an important part of the Biologics License Application, the Food and Drug Administration (FDA) of US has also requested for the submitting data from all the clinical trials of the vaccine across the world, along with the data on the use of the corona virus vaccine in real world.

Pascal Soriot, CEO of AstraZeneca said, they are having an enormous amount of the data, along with the clinical data of the vaccine and also all the data coming from the work, which the company have done across the world, and the Biologics License Application has been a much larger and important submission than the emergency use approval.

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The company has been able to promote its relatively cheap and easy-to-handle corona virus vaccine as a vaccine for the world, and the company has already received the authorization from over 170 corona virus vaccination.