At the same time, the company’s executive director Pascal Soriot stressed that AstraZeneca does not need FDA approval to increase the level of confidence in its drug in the world.
The British-Swedish pharmaceutical company AstraZeneca will continue to seek certification of its vaccine by the US Food and Drug Administration (FDA). This was stated on Thursday at a press briefing by the company’s executive director Pascal Soriot, quoted by Reuters.
“The simple answer is that this vaccine is important,” Soriot said, answering a question about why the company is still striving to bring its drug to the US market, where the population is already provided with the necessary number of vaccines. “We believe that it can still play an important role in the future, so we want to apply for the necessary license and get it.”
Soriot stressed that AstraZeneca does not need FDA approval to increase the level of confidence in its drug in the world, saying that AstraZeneca only wants the vaccine “to be ready for use if it is needed” in the United States. At the moment, the University of Oxford, where the vaccine was developed, which AstraZeneca produces, is working on creating modifications of the drug designed to combat new strains of coronavirus.
On Thursday, the company’s representatives also confirmed that they intend to initiate a more complex process of obtaining a full-fledged license from the FDA without applying to the agency for a necessary certificate for emergency use of the vaccine. The fact that such a possibility is being considered was reported back in April. Still, AstraZeneca has not yet provided the FDA with all the necessary documentation, including observation data for participants in protracted clinical trials of the drug in the United States. As a result, the United States has transferred several million doses of the AstraZeneca vaccine to countries already approved for use.
Earlier, AstraZeneca published a financial report, saying that in the first six months of this year, the company and its partners who produce the drug under license sold 700 million doses of the vaccine in more than 170 countries, including 80 million doses that AstraZeneca provided to developing countries through the World Health Organization, which implements the international COVAX program. The company’s revenues from the sale of the drug for this period amounted to $1.17 billion. According to Soriot, AstraZeneca has significantly increased its production capacity and currently has the ability to supply customers with about 200 million doses of the vaccine per month.