Pfizer At-Home COVID-19 Pill Gets FDA Green Light As Virus Surges

ACROSS AMERICA — The U.S. Food and Drug Administration on Wednesday authorized the use of Pfizer's new at-home pill to fight COVID-19, a milestone that came amid rising coronavirus infections, especially from the highly contagious omicron variant, and increased hospitalizations and death.

The drug, Paxlovid, has been shown in trials to hold the worst symptoms at bay when used by people with active COVID-19 infections. Health officials said the pill is a less expensive way to treat COVID-19 illnesses than previously approved treatments that required an IV or shot, but initial supplies will be extremely limited.

Eligibility for the pill will be limited to anyone over the age of 12 with compromised immune systems until the drug is broadly available, the FDA said.

In trials, the drug was shown to reduce by 90 percent hospitalizations and deaths among COVID-19 patients. With mild side effects, it's expected to be the preferred treatment, though the FDA is also poised to approve another at-home treatment, an antiviral pill from Merck.

Authorization comes as U.S. health officials worry about a tsunami of COVID-19 infections that could overwhelm hospitals in the days after Americans gather for Christmas and New Year's. The omicron variant accounted 73 percent of COVID-19 infections last week.

Omicron-variant COVID-19 illnesses appear to be less severe among vaccinated and boosted patients, but health officials say there's still much to learn about the variant, first detected in South Africa less than a month ago. There, illnesses appeared to be mild, but health officials warn that could be because those who got sick were mainly young people.

The nation's first known omicron-related death was reported Monday in the Houston area, where the variant was first detected on Dec. 7, and the COVID-19 threat assessment in Harris County was raised to "Level 2: Orange" on Monday.

The Associated Press contributed reporting.