Pfizer says Covid-19 pill near 90% effective in final analysis

New York, December 14

Pfizer Inc on Tuesday said final analysis of its antiviral Covid-19 pill still showed near 90% 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 89% 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 authorized, the treatment will be sold as Paxlovid.

Pfizer also released early data from a second clinical trial showing that the treatment reduced hospitalisations by around 70% in around 600 standard-risk adults.

“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.

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.

The efficacy of Pfizer’s pill in preventing hospitalisations and deaths in at-risk patients was widely expected, so the FDA’s decision could come within a matter of weeks, if not days, said Zarina Saidova, an analyst at Moscow-based Finam Holdings.

Saidova expects Paxlovid to generate $15 billion to $20 billion in revenue next year, a significant boost for the company in the face of a potential decline in vaccine sales.

There are currently no oral antiviral treatments for Covid-19 authorised in the United States. —Reuters