AstraZeneca to apply for COVID-19 vaccine approval in U.S. later in 2021

Vials with a sticker reading “COVID-19/Coronavirus vaccine/Injection only” are seen in front of a AstraZeneca logo in this illustration photo.   | Photo Credit: Reuters

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.

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. AstraZeneca has pledged to deliver the vaccine on a non-profit basis as long as the pandemic lasts. Its supplies include 80 million doses that went to the COVAX initiative for low and middle-income countries.

Overall, astrazeneca reported first-half revenue of $15.5 billion, up 23%, with around $1.17 billion accruing from the delivery of the Covid vaccines.

“Excluding the contribution from the pandemic COVID-19 vaccine, revenue increased by 14% [9% at CER] in the half to $14,371 million and by 17% [12% at CER] in the quarter to $7,326 million,” the results show.

“AstraZeneca has delivered another period of strong growth thanks to robust performances across all regions and disease areas, particularly Oncology, New CVRM and Fasenra in Respiratory. As a result, we have delivered further earnings progression, supported ongoing launches, and continued our investment in R&D,” said Pascal Soriot, Chief Executive Officer of AstraZeneca.

“We continue to advance our portfolio of life-changing medicines with further significant progress across disease areas,” he said.

The CEO highlighted that in the field of BioPharmaceuticals, the U.S. approved Farxiga for chronic kidney disease and granted tezepelumab “Priority Review” to treat patients with asthma.

Following the recent acquisition of rare disease therapy company Alexion, the company said it was updating its full-year 2021 guidance and long-term goals to accelerate scientific discovery.

“Alexion will enable us to enhance our pipeline, extending the company’s presence in rare diseases and immunology with its complement biology,” added Mr. Soriot.

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Printable version | Sep 17, 2021 4:25:31 PM |

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