AstraZeneca seeks U.S. approval for COVID vaccine
AstraZeneca said on Thursday that it intends to seek US authorization for its COVID-19 vaccine in the second half of this year, providing a new timetable for the long-delayed application.
The Anglo-Swiss pharmaceutical company announced this timetable when it released its second-quarter financial results, showing that the company and its sublicensees provided more than 700 million doses of vaccine to more than 170 countries in the first half of this year. This includes 80 million doses of vaccine used in the COVAX program for low- and middle-income countries.
The vaccine was developed by researchers at Oxford University, who licensed the technology to AstraZeneca to take advantage of the company’s global manufacturing and distribution capabilities. In turn, AstraZeneca authorized other companies to produce these lenses around the world.
As time goes by, news about US applications is being closely watched.
When AstraZeneca announced its US vaccine trial data on March 22, company officials stated that they expected to receive approval from the US Food and Drug Administration in the first half of April. In April of this year, the company stated that it expects to submit a U.S. application within “the next few weeks.”
Canada, The United Kingdom, the European Union and the World Health Organization have authorized the use of AstraZeneca vaccines.
AstraZeneca reported that the company’s direct delivery revenue of 319 million doses of vaccines was $1.17 billion. AstraZeneca promised to provide vaccines on a non-profit basis as long as the pandemic continues.
Despite the EU’s complaints about its vaccine supply, the 27-nation group received more vaccine doses directly from AstraZeneca in the first half of this year than any other single entity. The company shipped 97 million doses to the European Union, while Brazil received 65 million doses and the UK received 52 million doses.
AstraZeneca said. Gavi, the alliance that provides vaccines to low-income countries, received 49 million doses of vaccine, and another 57 million doses were used in other countries.
Sublicense holders, including the Serum Institute of India, have provided millions of doses of products, pushing global deliveries to more than 700 million doses.