At a time when COVID is surging again in the U.S. and more than 800,000 Americans have died from the virus over the last 22 months, there is some hopeful news from Pfizer on a COVID pill.
The company confirmed that the drug is highly effective at reducing hospitalizations and deaths when taken during the first three days of symptoms in high-risk patients.
Pfizer released findings on two studies Tuesday on their pill Paxlovid. The results now go to the FDA, which will soon take up if and when Americans could use it.
In a study of more than 2,200 people, Paxlovid was 89% effective in lowering hospitalizations and deaths. Researchers said 700 high-risk patients took the pill within three days of initial symptoms and only five people went to the hospital for COVID. Within five days of symptoms, eight out of 1,039 people were hospitalized. No one died.
Unvaccinated or vaccinated, this five-pill regimen taken once a day could make a huge difference.
"That's really good news. So, it's holding up under larger numbers of people. They're going to be submitting that to the FDA and hopefully we'll get some action on that soon," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
Pfizer says it can have 180,000 courses of Paxlovid at the ready once authorized and 80 million worldwide in 2022. This COVID pill is the second up for emergency authorization from the FDA.
Late last month an FDA advisory committee narrowly voted to recommend Merck's COVID drug. Merck's pill reduces hospitalizations and deaths by 30% in high-risk adults. But Merck and FDA findings showed it could lead to pregnancy complications and birth defects.
The Pfizer development comes as COVID-19 cases, deaths and hospitalizations are increasing, again. The surge is caused by the Delta variant, colder weather and more indoor gatherings. Health officials are also watching the emerging Omicron strain in 30-plus states and counting.
"It is going to spread like wildfire across the United States and we've got to be ready for it," said Dr. Ashish Jha, dean of the Brown University School of Public Health.
Pfizer shared results from a second study showing the pill is still potent against the Omicron variant. That's important because early lab results show current monoclonal antibody treatments lose most of their effectiveness when exposed to Omicron.
Pfizer has a rolling submission with the FDA on this drug, meaning that as it gets results and data in, it gets reviewed by the FDA. The same advisory panel that recommended Merck's pill will look at this one. That date isn't set yet, but it's expected soon.