COVID-19 / AstraZeneca will apply for US approval of the Covid vaccine later this year.

Zoom News : Jul 29, 2021, 08:35 PM

British-Swedish biopharmaceutical giant AstraZeneca, which makes the COVID19 vaccine developed by Oxford University scientists, said Thursday that it would apply for US Medicines Agency approval for its injections in the second half of this year. Vaccine  AZD1222 also manufactured under license from the Serum Institute of India (SII) as Covishield and approved for human use by the UK and European drug regulators, has filed an application with the US Food and Drug Administration (USFDA). 

As part of the second quarter financial results released Thursday, which showed that the company and its sub-licensees, including SII, delivered more than 700 million doses of the vaccine to more than 170 countries in the first half of this year, the approval plan indicates an application for approval from the FDA. for COVID19 AstraZeneca SARSCoV2 vaccine (US) later in the year.  The USFDA application timeline has been in the works since the end of March when AstraZeneca released data from its clinical trials of COVID19 vaccines in the US. AstraZeneca is committed to delivering the vaccine on a nonprofit basis while the pandemic continues. His shipments include 80 million cans that went to the COVAX initiative for low and middle-income countries. 

Overall, AstraZeneca posted sales of $ 15.5 billion for the first half, up 23%, of which approximately $ 1.17 billion came from deliveries of COVID vaccines.  "Excluding the contribution of the COVID19 pandemic vaccine, revenue increased 14% (9% in CER) in half to $ 14,371 million and 17% (12% in CER) in the quarter to $ 7,326 million," the results show.  AstraZeneca has achieved another period of strong growth thanks to strong performance across all disease regions and areas, particularly Oncology, New CVRM and Fasenra in Respiratory. As a result, we have achieved further revenue growth that underpins ongoing launches and we continue to invest in RandD, said Pascal Soriot, CEO of AstraZeneca.  We are continuing to develop our portfolio of life-changing drugs with significant additional advances in disease, he said.

The CEO noted that in the biopharmaceutical sector, the US has approved Farxiga for chronic kidney disease and granted Tezepelumab Priority Review for the treatment of asthma patients.  Following the recent acquisition of the rare disease therapy company Alexion, the company announced that it is updating its guidance for 2021 and its long-term goals to accelerate scientific discovery.  Alexion will allow us to improve our portfolio and expand the company's presence in the rare disease and immunology fields with its complementary biology, added Soriot.