The US Food and Drug Administration (FDA) on Wednesday authorized Pfizer’s Covid pill for high-risk people aged 12 and over, a major milestone in the pandemic that will allow millions to access the treatment.
“Today’s authorization introduces the first treatment for Covid-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said FDA scientist Patrizia Cavazzoni.
In an unusual move, the FDA did not convene its customary panel of independent experts to review in depth data surrounding Pfizer’s pill ahead of authorization.
The US has already paid for 10 million courses.
The highly-mutated variant is better able to bypass immunity conferred by prior infection, and health authorities are urging the public to get boosted with mRNA vaccines in order to restore a higher degree of protection.
Authorization is still awaited for another Covid pill, developed by Merck, which is also taken over five days and has been shown to reduce the same outcomes by 30 percent among high-risk people.
The two treatments work in different ways inside the body, and Pfizer’s pill is not thought to carry the same level of concerns.