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Pfizer says pill is effective in protecting against severe disease from Covid
Experimental antiviral pill Paxlovid is also effective against the Omicron variant, company announces
Health
A pill manufactured by the prominent Covid-19 vaccine provider Pfizer is highly effective in protecting against severe disease from coronavirus, the company said on Tuesday.
The experimental antiviral pill Paxlovid is also effective against the Omicron variant that is spreading rapidly across the world, the company announced, citing laboratory testing.
In clinical trials, Paxlovid showed almost 90% efficacy in preventing hospitalization and death in high-risk patients, Pfizer stated, replicating the results of a smaller-scale trial announced last month.
Those results prompted the company to seek authorization from the US food and drug administration (FDA) for the pill to become the first widely-available oral medicine to combat coronavirus.
Regulators in the UK last month approved the twice-daily pill Molnupiravir manufactured by Merck/Ridgeback for use in elderly and at-risk patients, but its approval has stalled in the US amid safety concerns.
Pfizer hopes that Tuesday’s announcement will bolster its case with the FDA, allowing for an early US approval and infected Americans having access to the pill by early next year.
“Our oral antiviral candidate, if authorized or approved, could have a meaningful impact on the lives of many, as the data further support the efficacy of paxlovid in reducing hospitalization and death and show a substantial decrease in viral load,” said Albert Bourla, the company’s chief executive, in a statement.
“This potential treatment could be a critical tool to help quell the pandemic.”
Pfizer’s latest study was an analysis of 2,246 unvaccinated, high-risk test subjects. None of those in the trial given paxlovid died, compared to 12 placebo recipients.
The Pfizer pills are taken every 12 hours. They reduced the risk of hospitalization or death by 89% within three days of symptom onset and 88% within five days.
Mikael Dolsten, Pfizer’s chief scientific officer, told Reuters that it was: “a stunning outcome”.
“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,” he said.
Dolsten said that more than 200 scientists had been working to develop the pill since early 2020, and that the initial hope had been for it to be at least 60% effective. It works by inhibiting a key enzyme known as a protease, which is prominent in the rapidly-spreading Omicron mutation of Covid-19.
“It’s very difficult for the virus to create a strain that can live without this protease,” Bourla said last month. “It’s not impossible. It’s very difficult.”
Dolsten said that Pfizer would have 180,000 courses of treatment ready if paxlovid was authorized soon, and that the company planned to make 80m courses available worldwide in 2022.
Meanwhile, a study in South Africa has suggested that the Pfizer vaccine has a weaker efficacy against Omicron in patients who have received two doses than it does against the Delta variant.
The research by Discovery Health, the country’s largest medical insurance administrator, calculated a 70% protection from hospitalization compared to the unvaccinated, and 33% protection against infection.
The group said that represented a drop from 93% hospitalization protection and 80% infection prevention for Delta. The findings were based on a study of more than 211,000 positive Covid-19 test results from mid-November until 7 December, with about 78,000 of those attributed to Omicron.