The FDA has just granted emergency authorization for Pfizer’s COVID pill this morning:
Here’s more from NBC News:
The Food and Drug Administration on Wednesday authorized the first Covid-19 antiviral pill in the United States to protect against severe disease.
The oral drug, called Paxlovid, from Pfizer will be prescribed for use in adults and children ages 12 and up with mild to moderate Covid who are at risk for severe disease or hospitalization, the FDA said in a statement.
The authorization marks “a major step forward” in the pandemic, Dr. Patrizia Cavazzoni, director of the agency’s Center for Drug Evaluation and Research, 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,” she said.
While the pill from Pfizer is not a replacement for vaccinations, they add an easily administered treatment to help keep people at high risk of severe illness out of the hospital.
The new treatment could help ease the burden on hospitals as the omicron variant surges across the U.S. Initially, the supply of the drug is likely to be extremely limited, experts say.
Pfizer CEO Albert Bourla said in a statement Wednesday that the company is ready to begin delivery of the drug to the U.S. “immediately.”
“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,” he said.
Pfizer has said a final analysis of its clinical trials found its drug to be 89 percent effective at preventing high-risk people from being hospitalized or dying from Covid, which was consistent with the results of the interim analysis the company released early last month. By comparison, clinical trials found Merck’s treatment reduced the risk of hospitalization and death among high-risk Covid patients by 30 percent.
A full course of Pfizer’s treatment is 30 pills — taken as three pills twice daily for five days. The treatment includes a low dose of ritonavir, a commonly used HIV drug, along with an antiviral developed by Pfizer called nirmatrelvir.
The treatment needs to be taken early to be effective — within five days of first symptoms, according to the FDA.
With the Omicron variant spreading rapidly, you can believe Pfizer will be poised to once again make tons of money on this drug. Despite the drug, I’m sure fascist governments everywhere will still be mandating vaccinations. But I hope this is the beginning of the end of all that. Seriously. It’s gotten way too far out of control.