Pfizer, a pharmaceutical company, has acquired full approval for its COVID-19 tablet Paxlovid, which has been the standard therapy for coronavirus.
Since the Food and Drug Administration approved emergency use of Paxlovid in late 2021, more than 11 million prescriptions have been filled. The emergency status was based on preliminary findings and was meant to be temporary pending additional research.
The FDA granted the approval for adults affected with coronavirus who face high risks of severe disease leading to hospitalization or death. This includes older adults and those with medical conditions like diabetes, asthma and obesity.
This keeps Pfizer’s drug in the market indefinitely and marketed similarly to other drugs. The pill is remains available for children ages 12 to 17 under a separate emergency authorization.
The FDA said in a statement that the US government has stockpiled millions of doses of Paxlovid and that patients would continue to receive it free of charge. Last month, more than 14,000 new COVID-19 cases were recorded per week, while the majority of cases in the United States are no longer reported to health authorities.
Paxlovid is the fourth COVID-19 medicine to achieve full FDA approval, and the first tablet. Previously approved medicines include IV or injectable medications, which are commonly administered in clinics or hospitals.
Pfizer initially tested Paxlovid on the most vulnerable COVID-19 patients: unvaccinated individuals with other health issues and no history of coronavirus infection. The FDA reported that when given promptly after symptoms appeared, the medication reduced the chance of hospitalization or death by 86%.
In more recent studies of people who have had COVID-19, Paxlovid still significantly decreased the chance of hospitalization or death by more than 85%.
As Paxlovid’s use spread in 2021, medical professionals and patients alike noted instances of COVID-19 symptoms reappearing many days following the drug’s administration.
