Pfizer has said that its antiviral pills to treat COVID-19 cut the risk of hospitalization or death in vulnerable adults by almost 90 percent, replicating results from an interim analysis announced last month. Data also suggests that the pill stands a good chance against the highly mutated Omicron variant, which is currently spreading like wildfire in many parts of the world.
In an announcement on Tuesday, December 14, Pfizer revealed the full results of its 2,246-person study investigating their anti-COVID treatment PAXLOVID.
They concluded that the pill reduced the risk of hospitalization and death in high-risk adults by 89 percent if given within three days of the onset of symptoms. It also reduced the risk of hospitalization or death for any cause by 88 percent compared to placebo in high-risk patients treated within five days of symptom onset. Importantly, the treatment produced very few adverse effects, most of which were relatively mild.
PAXLOVID is an oral pill that works by blocking the activity of an enzyme that SARS-CoV-2, the virus that causes COVID-19, needs to replicate. The latest results clearly highlight this effect, showing that the pill treatment results in an “approximate 10-fold decrease in viral load at day five, relative to placebo.” The idea is to give the drug to high-risk patients infected with COVID-19 as an oral antiviral therapy to reduce the risk of them requiring hospitalization or dying.
Pfizer has shared this fresh data with the US Food and Drug Administration (FDA) as part of its submission for Emergency Use Authorization. If the FDA gives the final thumbs-up, which could happen within the next few days, then patients in the US could start receiving it by the end of the year.
“This news provides further corroboration that our oral antiviral candidate, if authorized or approved, could have a meaningful impact on the lives of many, as the data further support the efficacy of PAXLOVID in reducing hospitalization and death and show a substantial decrease in viral load. This underscores the treatment candidate’s potential to save the lives of patients around the world,” Albert Bourla, Chairman and Chief Executive Officer of Pfizer, said in a statement.
“Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic.”