British-Swedish biopharma firm AstraZeneca, on Thursday, said that they would seek approval from the US medicines regulator for its jabs in the later half of 2021. AstraZeneca is a manufacturer of COVID-19 vaccine developed by scientists at the University of Oxford.
The vaccines AZD1222 is being actively produced and used in India under license by the Serum Institute of India (SII). Being referred to as Covishield, it is approved by the UK and European medicines regulators for human use. However, it 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 USFDA application has been in the works since AstraZeneca unveiled the data from its COVID vaccine clinical trials in the US. The biopharma giant has committed to providing vaccines on a non-profit basis till the end of the Pandemic. It has committed to delivering the jabs on a non-profit basis till the end of the Pandemic. Its supplies include 80 million doses that went to the COVAX initiative for low and middle-income countries.
"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 company is looking to update its 2021 guidance and expand its goals to boost scientific discovery and therefore, it recently acquired a rare disease therapy company Alexion.
“Alexion will enable us to enhance our pipeline, extending the company’s presence in rare diseases and immunology with its complement biology,” added Pascal Soriot.