FDA authorizes Pfizer, Merck COVID-19 antiviral pills

The Food and Drug Administration (FDA) has authorized a pair of COVID-19 antiviral pills that could change the dynamic of the ongoing pandemic.

According to two news releases, the agency issued emergency use authorization (EUA) for both the Pfizer Paxlovid antiviral pills and the Merck molnupiravir for treatment of patients who test positive for COVID-19 and who are at high risk for progression to severe forms of the disease as soon as possible after diagnosis and within five days of the onset of symptoms. Paxlovid is authorized in adult patients and in pediatric patients 12 years of age or older and weighing more than 88 pounds, while molnupiravir is only authorized for patients over the age of 18 as use in younger patients can affect bone and cartilage growth.

Paxlovid was authorized Dec. 22 with Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, touting the pill’s approval in the release.

“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 Cavazzoni at the time. “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 Merck pill was authorized the following day.

“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally. Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” Cavazzoni says in the Merck release. “As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness.”