AstraZeneca to Apply for Covid-19 Vaccine Approval in US Later in 2021

British-Swedish biopharma giant AstraZeneca, which manufactures the COVID-19 vaccine developed by scientists at the University of Oxford, on Thursday indicated that they would seek approval from the US medicines regulator for its jabs in the second half of this year. The AZD1222 vaccine, also being produced under licence by the Serum Institute of India (SII) as Covishield and approved for human use by the UK and European medicines regulators, is pending a US Food and Drug Administration (USFDA) application.

As part of second-quarter financial results released on Thursday, which showed that the company and its sub-licensees including SII delivered more than 700 million doses of the vaccine to over 170 countries in the first half of this year, the approvals timetable indicates a USFDA approval application for COVID-19 Vaccine AstraZeneca SARS-CoV-2 (US) later in the year.

The timeline for the USFDA application has been in the works since the end-March when AstraZeneca released the data…

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