辉瑞公司表示，其COVID口服药Paxlovid似乎对Omicron变体有效

On December 14, 2021, Pfizer said that its experimental COVID-19 oral drug appears to be effective against the Omicron variant.

In an analysis of 2,246 adult subjects, consistent with results from an interim analysis published in November, COVID-19 oral antiviral candidate Paxlovid significantly reduced the risk of hospitalization or death from any cause (89%) compared with placebo in non-hospitalized, high-risk adult patients with COVID-19 (treated within 3 days of symptom onset).

These data have been shared with the U.S. Food and Drug Administration (FDA) as part of the ongoing rolling submission for Emergency Use Authorization (EUA).

Pfizer said: "Recent in vitro data confirm that nirmatrelvir is a potent inhibitor of Omicron 3CL protease, and combined with existing in vitro antiviral and protease inhibition data on other variants of concern, including delta, indicate that PAXLOVID maintains strong antiviral activity against current variants of concern as well as other coronaviruses."

The updated data comes as COVID-19 cases, deaths and hospitalizations rise again, with the U.S. death toll from the pandemic surpassing 800,000. Even as health officials prepare for the impact of the emerging omicron variant, new cases driven by the delta variant continue to rise due to cooler weather and increased indoor gatherings.

The FDA is expected to decide soon whether to approve Pfizer's oral COVID-19 drug or Merck's oral drug, both of which were submitted to the agency weeks ago. If approved, the drugs would be the first COVID-19 treatments Americans can buy at pharmacies and take at home.

Pfizer's data will help reassure the FDA about its drug's benefit, after Merck reported lower-than-expected benefit in final testing. In late November, Merck said its treatment reduced hospitalization and death rates by 30% in high-risk adult COVID-19 patients.

Both companies are initially studying their treatments in unvaccinated adults who are at higher risk from COVID-19 due to older age or health problems such as asthma or obesity.

Pfizer also studied the effectiveness of its drug in low-risk adult groups (some of whom have been vaccinated against COVID-19), but reported mixed data on this group on the 14th.

Based on interim results, Pfizer said its drug failed to meet its primary study goal, as patients reported a failure to sustain relief during treatment or within four days after treatment. But the drug achieved its second goal, reducing hospitalizations by about 70% in this patient group, which includes healthy adults who have not received the COVID-19 vaccine and adults who have received the COVID-19 vaccine and have one or more health problems. Less than 1% of patients taking the drug were hospitalized, compared with 2.4% of patients taking the generic version.

An independent committee of medical experts reviewed the data and recommended that Pfizer continue the study to obtain complete results before working further with the FDA.

References:

https://www.foxnews.com/health/omicron-pfizer-covid-pill-appears-effective-variant