Pfizer on Tuesday said late-stage study results from its COVID-19 pill show it is effective at reducing the risk of hospitalization and death for high-risk adults. The pill is pending FDA approval, which could happen within days.

The treatment is called Paxlovid. It could be available in the U.S. before the end of 2021.

The research shows that Paxlovid is 89% effective against preventing hospitalizations and deaths in high-risk patients if given to patients within three days of onset symptoms. For standard-risk adults, Paxlovid reduced their chances of severe disease by 70%.

The pill is also effective against the Omicron variant, which has spread in Europe and Africa and currently accounts for 3% of infections in the U.S. If the pill is given within five days, the risk is reduced by 88%.

“Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus,” Pfizer chief executive Albert Bourla said in a statement, "and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic.”

The trial consisted of 1,200 people. No recipient who received the Pfizer treatment died, while 12 recipients died who received the placebo. The data released on Tuesday included an additional 1,000 participants.

Pfizer Chief Scientific Officer Mikael Dolsten said Paxlovid will reduce transmission dramatically and save a “staggering number” of lives.

The company plans to have 180,000 treatment courses shipped this year and another 80 million in 2022. Pfizer also plans to ship a generic version of the drug to 95 low and middle-income countries through a licensing agreement with Medicines Patent Pool.

The emergence of the life-saving pill comes as the U.S. approaches 800,000 deaths from the pandemic and as the cold and flu season nears.