AstraZeneca to apply for COVID-19 vaccine approval in U.S. later in 2021
The Hindu
The timeline for the USFDA application has been in the works since the end-March when AstraZeneca released the data from its clinical trials of the COVID-19 vaccine in the U.S.
British-Swedish biopharma giant AstraZeneca, which manufactures the COVID-19 vaccine developed by scientists at the University of Oxford, on July 29 indicated that they would seek approval from the U.S. 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 U.K. and European medicines regulators, is pending a U.S. Food and Drug Administration (USFDA) application. As part of second-quarter financial results released on July 29, 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 (U.S.)” later in the year.More Related News