The Food and Drug Administration on Wednesday approved a pill from drugmaker Pfizer that staved off hospitalization and death from COVID-19 in clinical trials, adding a major weapon to the U.S. arsenal against the virus.
Regulators said the pill, known as Paxlovid, should not replace vaccines as a way to prevent the disease but will be a vital tool in treating those who do get sick.
While other effective treatments exist, the pill is easy to administer and its authorization comes as the nation battles a potentially devastating winter surge.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “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 drug reduced the risk of hospitalization or death by 89% compared to a placebo group in a clinical study involving over 2,200 participants.
The drug is authorized for adults, particularly those who are at high risk of a bad outcome from COVID-19, and children who are at least 12 years old and weigh at least 88 pounds.
The challenge will be distributing enough pills to help everyone who needs the drug. It is given by prescription only and should be initiated as soon as possible after a diagnosis of COVID-19, within five days of symptom onset.
President Biden ordered 10 million courses of the drug in anticipation of approval, and efforts to broaden testing to detect who is positive will be critical in deploying the drug.
Paxlovid consists of nirmatrelvir, which helps to stop the virus from replicating, and ritonavir, which helps to keep the nirmatrelvir in the body for a longer period at higher concentrations.
It is given as three tablets — two tablets of nirmatrelvir and one tablet of ritonavir — taken together orally twice daily for five days, or a total of 30 tablets.
For more information, visit The Washington Times COVID-19 resource page.