Pharmaceutical agency AstraZeneca says it has not had any discussions with any U.S. authorities officers about an emergency use authorization for its coronavirus vaccine, Politico reviews.
The firm’s assertion comes a day after the Financial Times reported the White House would contemplate grant an emergency use of the AstraZeneca vaccine if a late-stage scientific trial at present happening within the U.Okay. and different nations has optimistic outcomes.
“It would be premature to speculate on that possibility,” the pharmaceutical firm mentioned in a press release.
The vaccine was developed by the University of Oxford. Currently, 11,000 individuals within the U.Okay., South Africa, and Brazil are enrolled in a scientific trial scheduled to finish later this yr.
AstraZeneca is planning the same trial within the U.S. it hopes will enroll 30,000 individuals, Politico reviews.
In May, the corporate signed a $1.2 billion deal to offer the U.S. with 300 million preliminary doses of the shot.
News of a attainable fast-tracked virus vaccine comes as President Donald Trump has accused the FDA of not performing shortly sufficient on approving attainable remedies. At the identical time, FDA Commissioner Stephen Hahn is working to guarantee Americans it is not going to sacrifice security or efficacy for pace, Politico reviews.
“Data is driving the development of all COVID-19 countermeasures,” HHS spokesperson Michael Caputo mentioned in a press release Monday. “Careless talk about career FDA experts somehow approving an unsafe and ineffective vaccine just for politics only undermines confidence in the public health system.”