The Food and Drug Administration on Wednesday authorized the first Covid-19 antiviral pill in the U.S. to protect against severe disease.
The oral drug from Pfizer, called Paxlovid, 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, it adds 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."
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The oral drug from Pfizer, called Paxlovid, 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, it adds 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."
source