Pfizer has announced it will stop enrollment in a clinical trial for Paxlovid – its COVID-19 antiviral pill – for standard-risk COVID-19 patients after the latest results suggested the drug did not reduce symptoms or hospitalizations and deaths to a statistically significant degree.
Paxlovid, which consists of two different antiviral drugs – nirmatrelvir and ritonavir – is currently approved or authorized for conditional or emergency use in more than 65 countries, including the United States, to treat COVID-19 patients at high risk of severe illness, including hospitalization or death.
Pfizer said on June 14 that it will “cease enrollment into the EPIC-SR trial due to low rate of hospitalization or death in the standard-risk population.”
However, the company said it will still include the new data in its upcoming application to the U.S. Food and Drug Administration (FDA) to seek full approval for Paxlovid to be prescribed for high-risk COVID-19 patients.
Standard-risk patients refers to COVID-19 patients who don’t have risk factors for severe disease. They can be vaccinated or unvaccinated.
The United States has spent more than $10 billion to order from Pfizer 20 million courses of Paxlovid.
Additionally, The White House has been seeking for more funds from Congress to support purchasing more of the antiviral pill as well as other treatments and vaccine booster doses.
The Centers for Disease Control and Prevention (CDC), warned in late May that some people may experience a rebound in COVID-19 symptoms after taking Paxlovid – meaning they may experience symptoms again after having had their symptoms resolved, or test positive for COVID-19 after having tested negative.