FILE IMAGE: Paxlovid, a pill caused by the Pfizer disease virus (COVID-19), manufactured in Ascoli, Italy, in this undated handout photo obtained by Reuters on November 16, 2021 Pfizer / Handout via REUTERS
December 14, 2021
By Michael Erman and Deena Beasley
NEW YORK (Reuters) – Pfizer Inc on Tuesday said its final analysis of its antiviral COVID-19 pill still found it nearly 90% effective in preventing hospitalization and death among patients. high risk, and recent laboratory data suggest that the drug remains effective against transmission of the Omicron variant of the coronavirus.
Last month, the U.S. drugmaker said the oral drug was about 89 percent effective at preventing hospitalization or death when compared with a placebo, based on interim results in about 1,200 people. The data disclosed Tuesday includes an additional 1,000 people.
No one in the trial treated with Pfizer died, compared with 12 deaths in those who received the placebo.
Pfizer is given with the older antiviral ritonavir every 12 hours for five days, starting soon after the onset of symptoms. If authorized, the treatment will be sold as Paxlovid.
“It’s an amazing result,” Pfizer Chief Scientific Officer Mikael Dolsten said in an interview.
“We are talking about an incredible number of lives saved and hospitalizations prevented. And of course, if you roll this out quickly after infection, we have the potential to reduce transmission significantly,” said Dolsten.
Pfizer also released initial data from a second clinical trial showing that the treatment reduced hospital admissions by about 70% in a smaller trial in standard-risk adults, including some vaccinated people at higher risk. The results were not statistically significant, but Pfizer said they show “positive data trends to reduce risk.” The trial did not show that the drug reduced symptoms of COVID-19 in the same population.
Results in standard-risk individuals are from interim analyzes in 60% and 80% of the trial’s enrollment is now fully enrolled in 1,100 people. Pfizer will continue to try it out and release more data when it’s done.
Dolsten said he hopes to soon get approval from the U.S. Food and Drug Administration and other regulators for use by people at high risk. He doesn’t believe an FDA advisory board meeting will be needed.
“We are engaged in very advanced regulatory dialogues with both Europe and the UK, and we have dialogues with most of the major regulators globally,” said Dolsten.
Pfizer filed data with the US FDA last month, requesting an emergency use authorization for the drug.
Zarina Saidova, an analyst at Moscow-based Finam Holdings, said the FDA’s decision could be made within weeks, if not days, said Zarina Saidova, an analyst at Finam Holdings. based in Moscow, as new data confirms what the company had previously disclosed and submitted to the regulator.
Saidova expects Paxlovid to generate $15 billion to $20 billion in revenue next year, a significant boost for the company amid a likely slump in vaccine sales.
There is currently no authorized oral antiviral treatment for COVID-9 in the United States.
Rival Merck & Co has requested an emergency use authorization for its antiviral drug molnupiravir. But that drug only reduced hospital admissions and deaths in high-risk patients by about 30%.
Some scientists have also raised safety concerns about Merck’s potential for birth defects, as well as concerns that it could cause the virus to mutate.
Pfizer’s drug works differently. It is part of a class of drugs called protease inhibitors that are currently used to treat HIV, hepatitis C, and other viruses.
Pfizer stock fell 0.8 percent to $54.75 in pre-chill trading, while Merck stock was flat at $72.69.
Dolsten said recent laboratory testing showed that the protease activity of the Omicron variant was “basically as good as any SARS-COV-2 variant of interest”.
The company says it may have 180,000 treatments ready to ship this year and plans to produce at least 80 million more by 2022.
Dolsten said Pfizer is looking to expand that production even further because new variants, like the newly discovered Omicron, could push demand for the antiviral essentially higher. Current vaccines appear to be less effective at preventing Omicron infections.
Pfizer, which makes one of the leading COVID-19 vaccines with German partner BioNTech, has agreed to allow generic drugmakers to supply versions of the drug to 95 low-income countries. and averaging through a licensing agreement with the international public health group Medicines Patent Pool (MPP). However, Dolsten said next year he expects the drug to be primarily made by Pfizer.
The US government has secured 10 million packs of Pfizer for $5.29 billion.
(Reporting by Michael Erman in New Jersey and Deena Beasley in Los Angeles, Additional reporting by Mrinalika Roy; Editing by Bill Berkrot, Anil D’Silva and Nick Zieminski)
https://www.oann.com/pfizer-says-covid-19-pill-near-90-effective-in-final-analysis/?utm_source=rss&utm_medium=rss&utm_campaign=pfizer-says-covid-19-pill-near-90-effective-in-final-analysis Pfizer says COVID-19 pill was nearly 90% effective in final analysis