NEW YORK: Pfizer Inc on Tuesday said final analysis of its antiviral Covid-19 pill still showed near 90pc efficacy in preventing hospitalisations 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 US drugmaker last month said the oral medicine was around 89pc effective in preventing hospitalisations or deaths when compared to placebo, based on interim results in around 1,200 people. The data 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 authorised, 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 hospitalisations 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 clinical trial suggesting that the treatment reduced hospitalisations by around 70pc in a smaller trial of standard-risk adults, including some higher-risk vaccinated people. The results were not statistically significant, but Pfizer said they showed a “positive data trend for reduction in risk.” The trial did not show that the drug alleviated symptoms of Covid-19 in the same population.
The results in standard-risk individuals are from interim analyses at 60pc and 80pc of enrollment of the now fully-enrolled trial of over 1,100 people. Pfizer will continue the trial and release more data when its done.
Dolsten said he expects authorisation for use in high-risk individuals from the US 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 US FDA last month, asking for emergency use authorization of the drug. The FDA’s decision could come within a matter of weeks, if not days, said Zarina Saidova, an analyst at Moscow-based Finam Holdings, as the new data confirms what the company previously disclosed and submitted to the regulator.
Published in Dawn, December 15th, 2021