The Food and Drug Administration announced Wednesday it has authorized Pfizer’s antiviral pills to treat COVID-19 for emergency use, allowing limited use of the drug in Americans as young as 12 who are at “high risk for progression to severe COVID-19.”

Early data suggests Pfizer’s pills, called Paxlovid, are effective against Omicron cases. The FDA said in a statement: “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”

The new treatment option comes as doctors are facing a nationwide shortage of monoclonal antibodies to treat high-risk cases of the disease, with most formulas ineffective against the fast-spreading Omicron variant. Paxlovid treatment needs to begin within a few days of first developing symptoms. A course of treatment is made up of three tablets that are taken twice a day, in the morning and evening, over the course of five days, for a total of 30 pills. Two of the tablets are nirmatrelvir, an antiviral Pfizer designed to target SARS-CoV-2, and one is ritonavir, a drug that has also been used to treat HIV.

Like with some other COVID-19 treatments that have been authorized by the FDA, the regulator will limit Pfizer’s drug to only people at “higher risk of being hospitalized for COVID-19.” That includes seniors and people with underlying conditions like heart disease or diabetes.  The FDA said Wednesday that “Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.”

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