A pill made by leading Covid-19 vaccine supplier Pfizer is highly effective in protecting against severe illness caused by the coronavirus, the company said Tuesday.
The experimental antiviral pill Paxlovid is also effective against the Omicron variant that is spreading rapidly around the world, the company announced, citing laboratory tests.
In clinical trials, Paxlovid was nearly 90% effective in preventing hospitalization and death in high-risk patients, Pfizer said, replicating the results of a smaller-scale trial announced last month.
Those results led the company to seek clearance from the U.S. Food and Drug Administration (FDA) for the pill to become the first widely available oral drug to fight coronavirus.
Regulators in the UK last month approved the pill Molnupiravir, made by Merck / Ridgeback, given twice a day, for use in elderly and at-risk patients, but its approval has stalled in the US. USA amid security concerns.
Pfizer hopes Tuesday’s announcement strengthens its case with the FDA, allowing early approval in the United States and allowing infected Americans to have access to the pill early next year.
“Our oral antiviral candidate, if licensed or approved, could have a significant impact on the lives of many, as the data further supports the efficacy of Paxlovid in reducing hospitalization and death and shows a substantial decrease in viral load. “said Albert Bourla. the CEO of the company, in a sentence.
“This potential treatment could be a critical tool to help quell the pandemic.”
Joe Biden said he is encouraged by the company’s data and that his administration has ordered enough pills to treat 10 million Americans.
“Vaccination and booster shots remain the most important tools we have to save lives. But if this treatment is truly authorized, and once the pills are widely available, it will mark an important step forward on our path out of the pandemic, “the US President said in a statement.
Pfizer’s latest study was an analysis of 2,246 unvaccinated, high-risk test subjects. None of those in the trial who received Paxlovid died, compared with 12 who received placebo.
Pfizer tablets are taken every 12 hours. They reduced the risk of hospitalization or death by 89% within three days of symptom onset and by 88% within five days.
Mikael Dolsten, Chief Scientific Officer, Pfizer, told Reuters which was “an amazing result”.
“We are talking about a staggering number of lives saved and hospitalizations prevented. And of course, if you implement this quickly after infection, we are likely to drastically reduce transmission, “he said.
Dolsten said that more than 200 scientists had been working to develop the pill since early 2020, and that the initial hope was that it would be at least 60% effective. It works by inhibiting an enzyme known as protease, which is prominent in Covid-19’s rapidly spreading Omicron mutation.
“It is very difficult for the virus to create a strain that can live without this protease,” Bourla said last month. “It is not impossible. It is very difficult.”
Dolsten said that Pfizer would have 180,000 treatment courses ready if Paxlovid were licensed soon, and that the company planned to make 80 million courses available worldwide by 2022.
Meanwhile, a study in South Africa has suggested that the Pfizer vaccine has weaker efficacy against Omicron in patients who have received two doses than against the Delta variant.
The Discovery Health research, the nation’s largest health insurance administrator, calculated 70% protection against hospitalization compared to the unvaccinated and 33% protection against infection.
The group said that represented a 93% drop in protection against hospitalization and 80% in infection prevention for Delta.
Reuters contributed to This report
George is Digismak’s reported cum editor with 13 years of experience in Journalism