By Michael Erman and Deena Beasley
NEW YORK – Pfizer Inc. on Tuesday said its antiviral COVID-19 pill showed near 90% efficacy in preventing hospitalizations and deaths in high-risk patients, and recent lab data suggests the drug retains its effectiveness against the fast spreading Omicron variant of the coronavirus.
The U.S. drugmaker last month said the oral medicine was around 89% effective in preventing hospitalizations or deaths when compared to placebo, based on interim results in around 1,200 people. Data from its final analysis of the trial disclosed on Tuesday includes an additional 1,000 people.
Nobody in the trial who received the Pfizer treatment died, compared with 12 deaths among placebo recipients.
The Pfizer pills are taken with the older antiviral ritonavir every 12 hours for five days beginning shortly after onset of symptoms. If authorized, the treatment will be sold as Paxlovid.
“It’s a stunning outcome,” Pfizer Chief Scientific Officer Mikael Dolsten said in an interview.
“We’re talking about a staggering number of lives saved and hospitalizations prevented. And of course, if you deploy this quickly after infection, we are likely to reduce transmission dramatically,” Dolsten said.
Pfizer also released early data from a second study suggesting that the treatment reduced hospitalizations by around 70% in a smaller trial of standard-risk adults, including some higher-risk vaccinated people.
Pfizer said those results showed a positive trend, but were not statistically significant. They are following the results and plan to release data from the final 20% of participants in the 1,100-patient trial.The trial did not show that the drug alleviated symptoms of COVID-19 in that population.
Dolsten said he expects authorization for use in high-risk individuals from the U.S. Food and Drug Administration and other regulatory agencies soon. He does not believe an FDA advisory panel meeting will be needed.
“We’re in very advanced regulatory dialogues with both Europe and the UK, and we have dialogues with most of the major regulatory agencies globally,” Dolsten said.
Pfizer submitted data to the FDA last month, asking for emergency use authorization (EUA) of the drug.
“These are very exciting results,” said Dr. Paul Sax, a professor at Harvard Medical School.
Sax said the FDA should try to accelerate the authorization process as much as possible, noting there are very limited treatment options for high-risk people outside of the hospital.
There are currently no oral antiviral treatments for COVID-19 authorized in the United States.
