Pfizer‘s antiviral Covid-19 pill Paxlovid has been authorized by the FDA for emergency use. The drugmaker says the pill, which could be available to patients as early as this weekend, is meant to treat mild to moderate Covid-19 diagnosis in patients who are at increased risk of hospitalizations or death.
The FDA said it authorized the drug for emergency use for the treatment in adults and pediatric patients of 12 years of age and older weighing at least 88 pounds, who are at high risk for progression to severe COVID-19. That includes older people and those with conditions like obesity and heart disease.
President Joe Biden welcomed the approval of the pill, saying that the US will have 250,000 treatment courses in January. “With today’s action, we add the first-ever oral treatment to our nation’s medicine cabinet and take a significant step forward in our path out of the pandemic,” Biden said in a statement.
The FDA emphasized in a statement that Paxlovid is not for pre- or post-exposure prevention of Covid-19 and “is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”
“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,” Dr. Patrizia Cavazzoni, director of the FDA’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.”
Pfizer’s pill is the first oral antiviral drug authorized by the FDA that is specifically designed to fight Covid. Earlier in November, the drugmaker revealed topline results from its trial showed an 89% reduction in the risk of hospitalization or death from Covid-19 among people given the drug within the first three days of symptom onset.
Last month the White House announced that the United States government had agreed to pay $5.29 billion for 10 million courses of Paxlovid.