The U.S. health regulator authorizes the Pfizer pill against COVID-19

“Today’s authorization introduces the first treatment for COVID-19 in the form of an oral pill – a major step forward in the fight against this global pandemic,” said FDA scientist Patrizia Cavazzoni.

Pfizer treatment, called Paxlovid, is a combination of two pills taken over five days that was demonstrated in a clinical trial of 2200 people that it was safe and reduced the risk of hospitalization and death in at-risk people by 88 percent. .

In an unusual move, the FDA did not convene its regular panel of independent experts to scrutinize data about the Pfizer pill prior to authorization.

Pfizer treatment has previously been authorized in the European Union.

The authorization comes as cases are growing across the United States dominated by Omicron, the most infectious variant of the first coronavirus to date.

The multi-mutation variant is better able to bypass the immunity granted by the previous infection, and health authorities are urging the public to receive booster vaccines in order to restore a higher degree of protection.

Unlike vaccines, the pill does not target the ever-evolving coronavirus protein, which it uses to invade cells. In theory, it should be immune to variants, and Pfizer has said that previous studies have supported this hypothesis.

Authorization is still pending for another COVID-19 pill, developed by Merck, which is also taken over five days and has been shown to reduce the same outcomes (hospitalization and death) by 30 percent in high-risk people.

Independent experts voted in favor of this treatment by a narrow margin, but expressed concerns about its safety, such as possible damage to the fetus and possible damage to DNA.

Both treatments work in different ways within the body and the Pfizer pill is not thought to have the same level of concern.

Merck’s treatment has received the green light from Britain and Denmark.

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