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WASHINGTON: The US Food and Drug Administration granted emergency authorization to Pfizer’s Covid treatment pill, a major milestone that promises to revolutionize the fight against the virus.
The FDA said it authorised Paxlovid for emergency use for the treatment of mild-to-moderate disease in adults and children 12 years and older who are at high risk for progression to severe Covid-19.
The drug is available by prescription only and should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset, the FDA said. The pills are meant to be taken every 12 hours for five days.
Pfizer’s antiviral regimen, Paxlovid, was nearly 90 percent effective in preventing hospitalisations and deaths in patients at high risk of severe illness, according to data from the company’s clinical trial. Recent lab data suggests the drug retains its effectiveness against Omicron, Pfizer said.
“Paxlovid’s approval is a major milestone that marks another step towards making Covid-19 a much more manageable infection,” said Amesh Adalja, a senior scholar at the Johns Hopkins Institute for Health Security.
“There are two key issues, however, that remain: It will be scarce in the coming weeks and its optimal use requires prompt diagnosis, which can be difficult with the continual testing problems that plague us,” Adalja added.
Pfizer raised its 2022 production projections to 120 million courses of treatment from 80m and said it was ready to start immediate delivery in the United States.
The US government will have 265,000 treatment courses available by January and supply will ramp up in subsequent months, White House Covid-19 response coordinator Jeff Zients told a briefing.
Pfizer has said it has 180,000 treatment courses ready to ship this year. The US government’s contract for 10m courses of the drug is priced at $530 per course.
The Food and Drug Administration’s decision to issue emergency authorisation for the treatment comes as the US combats a surge in Covid-19 cases driven by the Omicron variant, with President Joe Biden announcing plans for more federal vaccination and testing sites.
A rival pill from Merck & Co is under review by the FDA. The drug, molnupiravir, developed with Ridgeback Biotherapeutics, cut hospitalisation and death risk by 30pc in a trial.
