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US health regulator authorizes Pfizer’s Covid pill as Omicron surges


The United States on Wednesday authorized Pfizer’s
anti-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.

Not a ‘failure’ 

Biden defended his administration’s efforts during an
interview with ABC.

“No, I don’t think it’s a failure” that there
aren’t enough tests on shelves, the president said.

He has previously repeated that the country is
“ready” to handle a potential rise in hospitalizations and that those
who are vaccinated need not “panic.”

Health authorities have said Americans should avoid large
holiday gatherings and only get together in small numbers with people who are
vaccinated. 

Biden sought to reassure Americans, saying on ABC: “If
you are tested, if you know where you are in terms of having gotten the shots,
there’s no reason why you can’t get together with your family and your
friends.”

But two of his steps to combat the pandemic — a nationwide
vaccine requirement for large employers and a vaccine mandate for health care
workers — will soon be put to the test, as the US Supreme Court announced
Wednesday it will hold a special hearing on January 7 to consider challenges to
those policies.

“Especially as the US faces the highly transmissible
Omicron variant, it is critical to protect workers with vaccination
requirements and testing protocols that are urgently needed,” White House
press secretary Jen Psaki said about the special hearing Wednesday night. 

“We are confident in the legal authority for both
policies and (Department of Justice) will vigorously defend both at the Supreme
Court,” she said.

About 150,000 Americans are getting infected every day, with
7,800 being hospitalized and 1,200 dying, according to the latest Centers for
Disease Control and Prevention (CDC) data.

The highly mutated Omicron variant accounts for 90 percent
of all cases in some US regions, CDC director Rochelle Walensky told
reporters. 

Omicron is better able to bypass prior immunity, and health
authorities are urging the public to get boosted with mRNA vaccines in order to
restore a higher degree of protection.

Unlike vaccines, the Pfizer Covid pill does not target the
ever-evolving spike protein of the coronavirus, which it uses to invade
cells. 

It should therefore in theory be more
variant-proof, and the company has said preliminary lab studies have backed up
that hypothesis.



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