Vaccine certification
British-Swedish pharmaceutical company AstraZeneca will continue to push for certification of its vaccine by the US Food and Drug Administration (FDA). The company's chief executive, Pascal Soriot, told a press briefing on Thursday, according to Reuters.
"The simple answer is that this vaccine is important," Soriot said, when asked why the company was still keen to bring its drug to the US market, where the population is already supplied with the necessary amount of vaccines.
Soriot stressed that AstraZeneca does not need FDA approval to boost the credibility of its drug worldwide, saying that AstraZeneca only wants the vaccine to be ready for use should it be needed in the US. The University of Oxford, where the vaccine produced by AstraZeneca was developed, is currently working on modifications to the drug to target new strains of the coronavirus.
On Thursday, company officials also confirmed that they intend to initiate the more complicated process of obtaining a full licence from the FDA, without having to apply to the agency for the certification that is required for emergency use of the vaccine. That such a possibility was being considered was reported back in April, but AstraZeneca has yet to provide the FDA with all the necessary documentation, including observational data on participants in protracted US clinical trials of the drug. As a result, the United States has transferred several million doses of AstraZeneca's vaccine to countries where it has already been approved for use.
Earlier this year AstraZeneca published a financial report saying the company and its licensing partners sold 700 million doses of the vaccine in more than 170 countries in the first six months of the year, including 80 million doses that AstraZeneca distributed to developing countries under COVAX, the global health organisation's international programme.
The company's revenues from the sale of the drug amounted to $1.17bn during this period. AstraZeneca has significantly increased its production capacity and is now able to deliver around 200m doses of the vaccine per month to customers, Soriot said.
