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US authorises Pfizer’s Covid pill as Omicron variant surges

Paxlovid, which comprises two types of tablet, was granted an emergency use authorization by the Food and Drug Administration (FDA) after it was shown in a clinical trial to reduce the risk of hospitalizations and deaths among at-risk people by 88 per cent.
Paxlovid, which comprises two types of tablet, was granted an emergency use authorization by the Food and Drug Administration (FDA) after it was shown in a clinical trial to reduce the risk of hospitalizations and deaths among at-risk people by 88 per cent.
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Washington: The United States on Wednesday authorised 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 it was shown in a clinical trial to reduce the risk of hospitalizations and deaths among at-risk people by 88 per cent.


"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.


Every day, about 150,000 Americans are getting infected, 7,800 are being hospitalized and 1,200 are 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.


Paxlovid is a combination of a new molecule, nirmatrelvir, and HIV antiviral ritonavir, that are taken as separate tablets.


Nirmatrelvir blocks the action of an enzyme the virus needs to replicate, while ritonavir slows down nirmatrelvir's breakdown so it remains in the body for longer and at higher levels.


Synthetic antibody treatments developed by Eli Lilly and Regeneron are not effective against Omicron, top scientist Anthony Fauci told reporters, but an antibody treatment by GlaxoSmithKline (GSK) and a prophylactic antibody drug by AstraZeneca remain protective.


The US has bought a million courses of the GSK treatment, with 300,000 expected ready by January, and half a million doses of the AstraZeneca drug, which can be given preventatively to immune-compromised people who don't respond as well to vaccines. — AFP


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