Paxlovid, shown here being produced in Germany, is set to be a milestone in the pandemic
WASHINGTON - 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.
Pfizer's treatment, called Paxlovid, is a combination of two pills taken over five days that was shown in a clinical trial of 2,200 people to be safe and reduced the risk of hospitalizations and deaths among at-risk people by 88 percent.
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.
Pfizer's treatment has previously been authorized in the European Union.
The US has already paid for 10-million courses.
The authorization comes as cases are surging across the United States, driven by Omicron, the most infectious variant seen to date.
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.
Unlike vaccines, the Covid pill does not target the ever-evolving spike protein of the coronavirus, which it uses to invade cells. It should in theory be more variant proof, and Pfizer has said preliminary studies have backed up that hypothesis.
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.
Independent experts voted in favor of that treatment by a narrow margin, but expressed concerns surrounding its safety, such as potential harm to fetuses and possible damage to DNA.
The two treatments work in different ways inside the body, and Pfizer's pill is not thought to carry the same level of concerns.
Merck's treatment has been greenlit by Britain and Denmark.