The United States on Wednesday authorized Pfizer’s Covid pill for high-risk people aged 12 and up, as a surge of cases driven by the highly infectious Omicron variant threatened holiday plans and Americans struggled to find tests.
Paxlovid, which comprises two types of tablet, was granted an emergency use authorization by the Food and Drug Administration (FDA) after a clinical trial showed it to reduce the risk of hospitalizations and deaths among at-risk people by 88 percent.
“Today’s action is a testament to the power of science and the result of American innovation and ingenuity,” President Joe Biden said in a statement, promising to invoke a law that would help Pfizer ramp up production quickly.
The US has spent $5.3 billion procuring 10 million courses of the treatment, with the first 265,000 to be delivered in January and the rest by late summer, White House Covid response coordinator Jeff Zients told reporters on a call.
The FDA stressed the treatment should complement rather than replace vaccines, which remain the frontline tool against the coronavirus. But pills that are available at pharmacies are likely to be much easier to access than synthetic antibody treatments, which require infusions administered by drip at hospitals or specialized centers.
The European Union’s drug regulator last week allowed member states to use Pfizer’s Covid treatment ahead of formal approval as an emergency measure to curb a wave fuelled by Omicron, the most infectious variant seen to date.
The authorization comes as cases surge across the United States, where testing remains a challenge, with long lines reminiscent of the early part of the pandemic seen across US cities.
Companies including Amazon, Walgreens and CVS have capped how many home tests customers can buy.
The Biden administration has promised to ship half a billion of the tests starting from next month, but experts have said that figure is too little and too late.
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