Washington, Aug 23 (EFE).- The US Food and Drug Administration (FDA) on Monday licensed Pfizer-BioNtech’s two-dose Covid-19 vaccine, making it the first jab to be fully approved in the country.
Janet Woodcock, the acting FDA commissioner, called the step a “milestone” in the fight against the pandemic.
“The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” Woodcock said in a statement.
In mid-December, the vaccine was authorized for emergency use for people aged 16 and older and was extended to include children and adolescents aged 12 to 15 in May.
The full approval applies only to its use in people aged 16 and up, as Pfizer has to provide more data on those aged 12 to 15.
Emergency authorization can be used by the FDA during health emergencies to provide medical products that can be effective in preventing, diagnosing or treating a disease.
The full approval, meanwhile, lasts indefinitely unless the vaccine causes some kind of unexpected side effects.
To receive this license, the company must provide extensive data on the manufacturing process and be subject to FDA inspections.
The US authorities hope that the vaccination rate in the country will increase with Pfizer’s full approval.
More than 170 million residents in the US are fully vaccinated against Covid-19, over 92 million of whom have been inoculated with Pfizer.