Pharmaceutical manufacturer Pfizer will submit data to the Food and Drug Administration later this month after announcing Friday its oral COVID-19 treatment “significantly reduced hospitalization and death” in trials.
The PAXLOVID treatment reduced the symptoms and duration of COVID-19 through the combination of a pill called PF-07321332 that blocks the release of an enzyme the coronavirus needs to replicate with a low dose of ritonavir, an antiviral medication used to help treat HIV. The company will submit data to the FDA “as soon as possible,” an action the CEO said the company will take before Thanksgiving.
EARLY COVID-19 TREATMENTS SHOULD NOT BE IGNORED
“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” Pfizer CEO Albert Bourla said in a statement Friday. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”
The trials administered the treatment to 1,219 nonhospitalized adults with COVID-19 at high risk of progressing to severe illness three to five days after the onset of symptoms. Only 0.8%, or 3 out of 389 patients, of those who received the treatment were hospitalized after 28 days. The group that received a placebo or no treatment had a 7% rate of hospitalization or death, or 27 out of 385 patients, after the same time frame. All adults enrolled in the study by Sept. 29.
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Pfizer is the second pharmaceutical company to develop an oral treatment for COVID-19 after Merck requested emergency use authorization for its antiviral tablet last month.
The company's COVID-19 vaccine, the most widely administered in the United States, became the first to receive full FDA authorization in August. Last month, the federal agency cleared Pfizer's vaccine for use in children ages 5-11.