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FDA authorizes Pfizer’s Covid antiviral pill for people 12 and older
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<blockquote data-quote="Darrell Etherington" data-source="post: 5591"><p>Devindra Hardawar Contributor</p><p>Devindra Hardawar is a Senior Editor at <a href="https://www.engadget.com" target="_blank">Engadget</a>.</p><p>More posts by this contributor</p><ul> <li data-xf-list-type="ul"><a href="https://techcrunch.com/2021/11/10/congress-mandates-anti-drunk-driving-technology-for-cars/" target="_blank">Congress mandates anti-drunk driving technology for cars</a></li> <li data-xf-list-type="ul"><a href="https://techcrunch.com/2021/11/03/teslas-latest-patch-hints-at-cloud-synced-driver-profiles/" target="_blank">Tesla’s latest patch hints at cloud-synced driver profiles</a></li> </ul><p></p><p>The FDA has <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19" target="_blank">issued an emergency authorization</a> for Pfizer’s antiviral pill Paxlovid, making it the first oral method for treating mild to moderate cases of COVID-19. The treatment is meant for high-risk people 12 and older who could progress to a more serious COVID infection. The best part? The FDA says it could be available to use within a few days, making it another tool as we face the Omicron variant wave.</p><p></p><p>Paxlovid is available by prescription only, and it’s meant to be taken within five days of first noticing COVID symptoms. According to Pfizer’s tests, it can prevent hospitalization or death by 88 percent in high-risk patients. The treatment, which can be prescribed to both vaccinated and unvaccinated people, consists of 30 pills taken over five days. It includes the protein inhibitor nirmatrelvir and rotinavir, which keeps that inhibitor from breaking down in your body. Side effects include an impaired sense of taste, high blood pressure, diarrhea and muscle aches.</p><p></p><p>“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.</p><p></p><p>So far, the US has ordered enough pills to treat 10 million people, the <a href="https://www.nytimes.com/2021/12/22/health/pfizer-covid-pill-fda-paxlovid.html" target="_blank"><em>New York Times reports</em></a>. The company plans to deliver enough pills to cover 65,000 Americans within a week. And after that, production is expect to ramp up, with 150,000 courses delivered in January and 150,000 in February. It also won’t be the only antiviral pill around: Merck’s competing treatment is expected to be approved soon, and it’ll likely be more readily available than Pfizer’s. Merck’s option is far less effective, though—tests show it can only prevent hospitalization or death by 30 percent. (Still, that’s better than having no treatment.)</p><p></p><p></p><p><strong>Editor’s note:</strong> <em>This article originally appeared on <a href="https://www.engadget.com/fda-pfizer-covid-antiviral-pill-paxlovid-205104688.html" target="_blank">Engadget</a>.</em></p></blockquote><p></p>
[QUOTE="Darrell Etherington, post: 5591"] Devindra Hardawar Contributor Devindra Hardawar is a Senior Editor at [URL='https://www.engadget.com']Engadget[/URL]. More posts by this contributor [LIST] [*][URL='https://techcrunch.com/2021/11/10/congress-mandates-anti-drunk-driving-technology-for-cars/']Congress mandates anti-drunk driving technology for cars[/URL] [*][URL='https://techcrunch.com/2021/11/03/teslas-latest-patch-hints-at-cloud-synced-driver-profiles/']Tesla’s latest patch hints at cloud-synced driver profiles[/URL] [/LIST] The FDA has [URL='https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19']issued an emergency authorization[/URL] for Pfizer’s antiviral pill Paxlovid, making it the first oral method for treating mild to moderate cases of COVID-19. The treatment is meant for high-risk people 12 and older who could progress to a more serious COVID infection. The best part? The FDA says it could be available to use within a few days, making it another tool as we face the Omicron variant wave. Paxlovid is available by prescription only, and it’s meant to be taken within five days of first noticing COVID symptoms. According to Pfizer’s tests, it can prevent hospitalization or death by 88 percent in high-risk patients. The treatment, which can be prescribed to both vaccinated and unvaccinated people, consists of 30 pills taken over five days. It includes the protein inhibitor nirmatrelvir and rotinavir, which keeps that inhibitor from breaking down in your body. Side effects include an impaired sense of taste, high blood pressure, diarrhea and muscle aches. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. So far, the US has ordered enough pills to treat 10 million people, the [URL='https://www.nytimes.com/2021/12/22/health/pfizer-covid-pill-fda-paxlovid.html'][I]New York Times reports[/I][/URL]. The company plans to deliver enough pills to cover 65,000 Americans within a week. And after that, production is expect to ramp up, with 150,000 courses delivered in January and 150,000 in February. It also won’t be the only antiviral pill around: Merck’s competing treatment is expected to be approved soon, and it’ll likely be more readily available than Pfizer’s. Merck’s option is far less effective, though—tests show it can only prevent hospitalization or death by 30 percent. (Still, that’s better than having no treatment.) [B]Editor’s note:[/B] [I]This article originally appeared on [URL='https://www.engadget.com/fda-pfizer-covid-antiviral-pill-paxlovid-205104688.html']Engadget[/URL].[/I] [/QUOTE]
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