Pfizer Inc said Tuesday that the final analysis of its COVID-19 pill continued to show close to 90% efficacy in preventing hospitalizations and deaths in high-risk patients, and that recent laboratory data suggests that the drug retains its efficacy against the omicron variant.
Last month, the US pharmaceutical company claimed that its oral drug was about 89% effective in preventing hospitalizations or deaths compared to a placebo, based on interim results obtained in about 1,200 people. The data released Tuesday includes another 1,000 people. In the trial, none of the people who received the Pfizer treatment died, compared with 12 deaths among those who received the placebo.
Pfizer pills are taken together with the old antiviral ritonavir every 12 hours for five days from the start of symptoms. If authorized, the treatment will be sold as Paxlovid.
Pfizer has also released initial data from a second clinical trial showing that the treatment reduced hospitalizations by about 70% in about 600 standard-risk adults.
“It is a surprising result“Said Pfizer Chief Scientific Officer Mikael Dolsten in an interview.
“We are talking about a staggering number of lives saved and hospitalizations that have been avoided. And of course, if this is implemented quickly after infection, we are likely to drastically reduce transmission.“, he pointed.
Dolsten said he hopes the US Food and Drug Administration and other regulatory bodies will soon authorize its use in high-risk people. He does not think a meeting of the FDA advisory committee is necessary.
“We are in very advanced regulatory negotiations with both Europe and the UK, and we have discussions with most of the major regulatory agencies globally”, Dijo Dolsten.
There is currently no oral antiviral treatment for COVID-9 licensed in the United States.
The company has said it may have 180,000 treatments ready to ship this year and plans to produce at least 80 million more in 2022.
The US government has already obtained 10 million doses of the drug from Pfizer for $ 5.29 billion.
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