US regulators authorize pill to treat Covid-19

Washington, Dec 22 (EFE).- Regulators in the United States gave approval Wednesday to a prescription oral anti-viral medication meant to prevent people with Covid-19 patients from requiring hospitalization as the country experiences a nearly 30 percent increase in cases due to the Omicron variant.

Pfizer’s Paxlovid is the first coronavirus treatment in pill form to receive emergency use authorization from the US Food and Drug Administration (FDA).

The only other anti-viral approved so far for use with Covid-19 is Remdesivir, which is administered intravenously, but Merck is seeking FDA authorization for its molnupiravir pill.

Paxlovid should be prescribed for adults and children 12 and up (with a weight of at least 40kg/88lbs) with mild-to-moderate coronavirus “who are at high risk for progression to severe COVID-19, including hospitalization or death,” the FDA said.

Treatment with Paxlovid “should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset,” according to an FDA statement.

Pfizer said that in clinical trials, Paxlovid reduced hospitalization and death in high-risk patients by 89 percent.

The latest data show that one of the components in the medication is a “potent inhibitor” when used against the Omicron variant, the company said.

“Pfizer stands ready to begin delivery in the U.S. immediately to help get Paxlovid into the hands of appropriate patients as quickly as possible,” the pharmaceutical giant’s CEO and chairman, Albert Bourla, said.

While the company hopes to produce 120 million packets containing 30 pills each (the full treatment course) in the course of 2022, the immediate target is making enough Paxlovid for 30 million people by the middle of next year.

The US government has already acquired 60,000 of the 180,000 packets Pfizer is on track to deliver by the end of 2021. And President Joe Biden’s administration has signed contracts for 10 million courses of Paxlovid and 3.1 million of Merck’s molnupiravir.

The average number of new Covid-19 cases per day across the US has climbed almost 30 percent in the last two weeks, but here in Washington, the increase has been on the order of 440 percent, and New York has seen the pace of new infections double.

Omicron accounted for 73.2 percent of new cases in the US during the period Dec. 12-18, the Centers for Disease Control and Prevention said Monday.

The US leads the world in Covid-19 deaths, with 809,000, and confirmed cases, which stand at 51.4 million. EFE


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