Pill for Covid is nearly 90% effective in final analysis, says Pfizer

Pfizer said on Tuesday (14) that the final analysis of its antiviral pill for Covid showed nearly 90% effectiveness in preventing hospitalizations and deaths in high-risk patients. Furthermore, recent laboratory data suggest that the drug maintains its effectiveness against the rapidly spreading omicron variant of the coronavirus.

The US lab said last month that the drug taken orally was about 89% effective in preventing hospitalizations and deaths, when compared with a placebo, based on tentative results from about 1,200 people. The data revealed on Tuesday include over a thousand people.

No one in the trial who received the Pfizer treatment died, but there were 12 deaths among those who received the placebo.

Pfizer’s drug is taken with the older antiviral ritonavir every 12 hours for five days, starting shortly after symptoms appear. If authorized, the treatment will be sold under the name Paxlovid.

Pfizer also released preliminary data from a second clinical trial showing that the treatment reduced admissions by about 70% in approximately 600 standard-risk adults.

“It’s a surprising result,” said Pfizer Scientific Director Mikael Dolsten.

“We’re talking about a staggering number of lives saved and hospitalizations averted. And, of course, if we use it quickly after infection, we’re likely to drastically reduce infections,” said Dolsten.

He said he expects soon authorization from the Food and Drugs Agency (FDA) and other regulatory bodies for the use of the drug by high-risk individuals. He does not believe there will be a need for an FDA advisory panel meeting.

“We are in very advanced regulatory dialogues with Europe and the UK, and we have dialogues with most of the world’s major regulatory agencies,” said Dolsten.

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

Rival drugmaker Merck has sought authorization for emergency use of its antiviral pill molnupiravir. But this drug only reduced hospitalizations and deaths in the clinical trial with high-risk patients by about 30%.

Some scientists have also raised safety concerns about the potential for the Merck drug to cause birth defects, as well as fears that it could cause mutations in the virus.

Pfizer’s remedy works differently. It is part of a class of drugs called protease inhibitors, currently used to treat HIV, hepatitis C and other viruses.

Dolsten said recent laboratory tests have shown that the activity against the omicron variant’s protease is “basically as good as any Sars-Cov-2 variant of concern.”

The company said it could have 180,000 treatments ready for delivery this year and plans to produce at least 80 million by 2022.

Dolsten said Pfizer is looking to expand that production as new variants, such as the newly discovered omicron, substantially increase the need for antivirals. Current vaccines seem less effective at preventing omicron infection.

Pfizer, which manufactures one of the leading Covid-19 vaccines with German partner BioNTech, has agreed to allow generic manufacturers to supply versions of the drug to 95 low- and middle-income countries through a licensing agreement with the international group of Public health Medicines Patent Pool (MPP). However, Dolsten said that next year he expects the drug to be produced primarily by Pfizer.

The United States government has already guaranteed 10 million treatments with Pfizer’s drug, for US$ 5.29 billion (R$ 29.36 billion).