WASHINGTON: The US Food and Drug Administration (FDA) on Wednesday authorized Pfizer’s Covid pill for high-risk people aged 12 and over, calling it an important milestone in the pandemic that will allow millions to access the treatment.
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 when taken within five days of symptom onset.
“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 a statement.
“This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat Covid-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” added Pfizer CEO Albert Bourla in a statement.
The FDA stressed it should complement rather than replace vaccines, which remain the frontline tool against the coronavirus.But pills that are available at pharmacies should be much easier to access than synthetic antibody treatments, which require infusions administered by drip at hospitals or specialized centers.
In an unusual move, the FDA did not convene its customary panel of independent experts to review the in-depth data surrounding Pfizer’s pill ahead of authorization.
The European Union´s drug regulator last week allowed member states to use Pfizer’s Covid treatment ahead of formal approval, as an emergency measure to curb an Omicron-fueled wave. The US has agreed to pay $5.3 billion for 10 million courses, with delivery starting this year and concluding next, according to Pfizer.
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 prior immunity, and health authorities are urging the public to get boosted with mRNA vaccines in order to restore a higher degree of protection.