LONDON: Astrazeneca said on Thursday that he intended to seek US approval for the Covid-19 vaccine in the second half of this year, then delayed the application that had long been awaited.
The Anglo-Sweden drug maker announced a new schedule as the company said and the partners had provided more than 1 billion doses of vaccines to more than 170 countries where it had been authorized to use.
AstraZeneca said he had decided to request US food and drug administration for full regulatory approval of the vaccine, instead of authorization of quick emergency use which was originally anticipated.
As part of this biological license application, the FDA has requested extensive data from clinical trials throughout the world, as well as data on the use of real world vaccines.
“We have a large number of data, clinical data and all data originating from the work we do throughout the world,” said CEO Pascal Soriot in a conference call with reporters.
“BLA is a much greater submission than the approval of emergency use.” News in US archiving is being watched tightly because the schedule has slipped in recent months.
When Astrazeneca released data from US courts from vaccines on March 22, company officials said they were expected to find FDA authorization in the first half of April.
Among the worries of Astrazeneca must overcome reports that vaccines can be associated with rare blood clots, which have caused several countries to limit their use to younger people.
Astrazeneca vaccines have been used widely throughout the world after approval by regulators in the European Union, the World Health Organization, Britain and other countries.
While the US is currently “supplied properly” with vaccines, Astrazeneca believes that his shot can “play a role in the future,” Soriot said.
“It’s a good vaccine, and we just want to make sure it’s ready to use if necessary,” he said.
AstraZeneca said on Thursday that he delivered 319 million doses of vaccines in the first half of this year, $ 1.17 billion in income.
Astrazeneca has promised to send a vaccine in a non-profit during the pandemic.
Although there are complaints from the EU about the supply of vaccines, block 27 countries receive more direct doses of astrazeneca than other single entities in six months to June to June to June to June.
The company sent 97 million doses to the EU, while Brazil received 65 million and U.K.
52 million, said AstraZeneca.
Gavi, an alliance that secured a vaccine for low-income countries, received 49 million doses, and 57 million other doses went to another country.
Sub-holders of licenses, including the Institute of India, supply millions of doses.
This vaccine was developed by the University of Oxford researchers, who licensed the technology to Astrazeneca in an effort to utilize the company’s global production and distribution capacity.
AstraZeneca, in turn, authorizes other companies to produce shots around the world.