AstraZeneca to apply for COVID-19 vaccine approval in US later in 2021

By: |
July 29, 2021 4:48 PM

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.

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 US.

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 from its clinical trials of the COVID-19 vaccine in the US. 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 USD 15.5 billion, up 23 per cent, with around USD 1.17 billion accruing from the delivery of the COVID vaccines.

“Excluding the contribution from the pandemic COVID-19 vaccine, revenue increased by 14 per cent (9 per cent at CER) in the half to USD 14,371 million and by 17 per cent (12 per cent at CER) in the quarter to USD 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 US 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 Soriot.

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