Pfizer said on Tuesday that the Covid-19 vaccine is highly effective in protecting against severe disease from coronaviruses.
The company said that Paxlovid is effective against the Omicron variant that is spreading rapidly across the world.
Pfizer stated that Paxlovid showed almost 90% efficacy in preventing hospitalization and death in high-risk patients in clinical trials.
The company applied to the FDA for permission to make the pill to fight coronaviruses.
The twice-daily pill was approved in the UK for use in elderly and at-risk patients, but its approval in the US is on hold due to safety concerns.
Pfizer hopes that Tuesday's announcement will bolster its case with the FDA, allowing for an early US approval and the pill to be available to Americans by early next year.
Albert Bourla, the company's chief executive, said that the data further supports the efficacy of the oral antiviral candidate, which could have a meaningful impact on the lives of many.
The treatment could be a critical tool to help quell the epidemic.
Pfizer analyzed 2,246 unvaccinated, high-risk test subjects. There were no deaths in the trial of Paxlovid compared to placebo recipients.
Pfizer pills are taken every 12 hours. They reduced the risk of hospitalization or death within a few days.
Pfizer's chief scientific officer told the news agency that it was a stunning outcome.
There are a lot of lives saved and hospitalizations prevented. He said that if you deploy this quickly, we are likely to reduce transmission dramatically.
The initial hope was for the pill to be at least 60 percent effective, but more than 200 scientists have been working on it since early 2020. It works by blocking a key enzyme that is found in the rapidly spreading Omicron mutation of Covid-19.
Bourla said last month that it was difficult for the virus to create a strain that could live without the protease. It is not impossible. It is very difficult.
Pfizer will have 180,000 courses of treatment ready if the FDA approves the drug, and the company will make 80 million courses available worldwide in 2022, according to the company's CEO.
A study in South Africa suggests that the Pfizer vaccine has a weaker efficacy against Omicron in patients who have received two doses than it does against the Delta variant.
Discovery Health, the country's largest medical insurance administrator, calculated a 70% protection from hospitalization compared to the unvaccinated and 33% protection against infection.
The group said that the protection from hospitalization and infections for Delta had dropped. More than 211,000 positive Covid-19 test results from mid-November to December were studied and attributed to Omicron.
The report was contributed to by the news agency.