SILVER SPRINGS, MD, December 22, 2021 – Today, the Food and Drug Administration authorized Pfizer’s Paxlovid for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risks of hospitalization. Children eligible for the drug must weigh at least 88 pounds.
Paxlovid, is an alternative treatment for early COVID-19 infections to head off the worst effects of the virus. All of the previously authorized drugs against the disease require an IV or an injection.
Pfizer will ship tens of thousands of treatment courses in the U.S. before the end of this year, and hundreds of thousands at the start of 2022, a spokeswoman said. The U.S. government has agreed to pay $5.29 billion to purchase 10 million treatment courses that Pfizer will deliver by the end of next year.
Each treatment course consists of three pills taken twice a day for five days. Two of the pills are Paxlovid and the third, ritonavir, is an antiviral to help boost levels of Paxlovid in the body. Paxlovid has only proven effective if given within five days of symptoms appearing.
The FDA based its decision on company results from a 2,250-patient trial that showed the pill cut hospitalizations and deaths by 89% when given to people with mild-to-moderate COVID-19 within three days of symptoms. Less than 1% of patients taking Paxlovid were hospitalized, and none died at the end of the 30-day study period, compared with 6.5% of patients hospitalized who took the placebo, which included nine deaths.
Pfizer has said laboratory tests indicate that Paxlovid could work against the Omicron variant, in part because the drug works differently than other therapies targeting the spike protein on the virus.