Pfizer says its new COVID-19 pill cuts risk of hospitalization and death among high-risk patients by 89%, will file for FDA authorization by Thanksgiving


Pfizer hyped its experimental antiviral pill that treats COVID-19 on Friday. The drugmaker announced that the pill – Paxlovid – reduced hospitalizations and deaths in high-risk patients by 89% in clinical trials.

Pfizer's drug – known as PF-07321332 – is a SARS-CoV-2 protease inhibitor antiviral therapy that is ingested. PF-07321332 blocks an enzyme that the virus needs to replicate. Pfizer's ingestable COVID-19 treatment is coadministered with a low dose of ritonavir – an older antiviral medication commonly used in treatments for HIV. Ritonavir “helps slow the metabolism, or breakdown, of PF-07321332 in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus,” Pfizer said.

Pfizer's trial featured 1,219 unvaccinated high-risk adults who were infected with COVID-19. Within either three days of symptom onset, the study's participants were given a Paxlovid pill or a placebo every 12 hours for five days.

The trial found that 0.8% of the 607 people who were given Paxlovid were hospitalized compared with 7% of the 612 patients who were given a dummy pill. None of the people who were given the COVID-19 pill died, and there were 10 deaths among the participants who received the placebo.

Pfizer said the trial was stopped early because the effect was so impressive, and would soon attempt to get the COVID-19 pill approved by the FDA.

“At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), Pfizer will cease further enrollment into the study due to the overwhelming efficacy demonstrated in these results and plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible,” Pfizer said.

Pfizer CEO Albert Bourla told CNBC that the drugmaker plans to submit authorization filing to the Food and Drug Administration before Thanksgiving.

In a statement, Bourla said, “Today's news is a real game-changer in the global efforts to halt the devastation of this pandemic.”

“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,” Bourla said.

Annaliesa Anderson – chief scientific officer for Pfizer's hospitals business unit – said, “We are really over the moon that we did see such high efficacy in this study. It has tremendous implications for patients globally.”

Bloomberg reported, “In a third large trial, Pfizer is exploring if the drug could be used as a prophylactic medicine for people who live with someone who has come down with COVID-19, meaning a person would take the drug to avoid contracting the virus.”

“A Pfizer spokesperson said the company currently expects to produce more than 180,000 packs of the drug by the end of this year, and anticipates making at least 50 million packs by the end of 2022, with 21 million produced in the first half of the year,” the outlet added.

Pfizer has not indicated how much the COVID-19 pill would cost.

Pfizer's announcement of a COVID-19 pill arrives one day after the U.K. approved an oral treatment for coronavirus by Merck and Ridgeback Biotherapeutics. Merck's COVID-19 pill – branded as Lagevrio – uses the drug molnupiravir to introduce errors into the genetic code of the virus to prevent it from multiplying. Patients who received molnupiravir within five days of COVID-19 symptoms had about a 50% decrease in the rate of hospitalization and death.

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