SAN DIEGO (KGTV) – The first antiviral pill to treat COVID-19 will begin arriving at U.S. pharmacies in days, a welcome reinforcement for doctors who have few options that hold up against the lightning-fast omicron variant.
The Food and Drug Administration granted Pfizer emergency authorization Wednesday for its oral antiviral Paxlovid. In a clinical trial, the drug reduced hospitalizations and deaths in high-risk people by 88 percent.
Pfizer said it would ship enough pill courses for 65,000 Americans within one week.
Until the arrival of omicron, the most effective COVID-19 treatments were monoclonal antibodies, which target the outer shell of the coronavirus. Omicron has rendered all but one of the available antibody drugs ineffective because of mutations in its spike protein.
Instead of targeting the outer shell, Paxlovid interferes with a key enzyme the virus needs to replicate. That makes the drug less susceptible to surface-level mutations, said Dr. Robert Schooley, an infectious disease expert at UC San Diego.
“I see the Pfizer pill as a major advance,” Dr. Schooley said.
With omicron now causing the majority of infections, doctors have stopped using monoclonal antibody treatments from Regeneron and Eli Lilly.
Demand for the last remaining effective antibody, from GSK, has soared, and the drug is now in short supply.
“The federal government is controlling the distribution of that, and we only have a fridge or so left — about a week and a half of supply,” said Dr. Christian Ramers of Family Health Centers of San Diego.
FHCSD operates monoclonal antibody clinics in Hillcrest and Chula Vista on alternating days, Monday through Friday.
“We’re having to now triage to the sickest and most high-risk people that are getting treatment now,” he said. “If you’re vaccinated and you’re young, without risk factors, you probably won’t get a monoclonal.”
Doctors will reserve Pfizer’s pill for people at high risk. The FDA’s emergency authorization limits the pills to individuals 12 and older with high-risk conditions like cancer, diabetes, lung disease, or obesity.
One course of Paxlovid is 30 pills. It’s given over five days: three capsules, twice per day.
Patients must start taking the pills within five days of their symptoms. To get the capsules, they will need a positive coronavirus test and a prescription from a doctor.
The prescription is designed to ensure the individual isn’t taking other drugs that might interact with Paxlovid. People with severe kidney disease or liver impairment need further counseling on whether to take the drug, the FDA said.