Pfizer pill becomes 1st US-authorized home COVID treatmen

Pfizer pill becomes 1st US-authorized home COVID treatment

 

This image provided by Pfizer in October 2021 shows the company's COVID-19 Paxlovid pills. U.S. health regulators on Wednesday, Dec. 22, 2021 authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus. (Pfizer via AP)

 

MATTHEW PERRONE

Wed, December 22, 2021, 12:20 PM·4 min read

 

 

WASHINGTON (AP) — U.S. health regulators on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus.

The long-awaited milestone comes as U.S. cases, hospitalizations and deaths are all rising and health officials warn of a tsunami of new infections from the omicron variant that could overwhelm hospitals.

The drug, Paxlovid, is a faster, cheaper way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an IV or an injection.

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An antiviral pill from Merck also is expected to soon win authorization. But Pfizer's drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness, including a nearly 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.

“The efficacy is high, the side effects are low and it’s oral. It checks all the boxes,” said Dr. Gregory Poland of the Mayo Clinic. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group — that’s stunning.”

The Food and Drug Administration authorized Pfizer's drug for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risks of hospitalization. That includes older people and those with conditions like obesity and heart disease. Children eligible for the drug must weigh at least 88 pounds (40 kilograms).

The pills from both Pfizer and Merck are expected to be effective against omicron because they don’t target the spike protein where most of the variant’s worrisome mutations reside.

Pfizer currently has 180,000 treatment courses available worldwide, with roughly 60,000 to 70,000 allocated to the U.S. Federal health officials are expected to ration early shipments to the hardest hit parts of the country. Pfizer said the small supply is due to the manufacturing time — currently about nine months. The company says it can halve production time next year.

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所有跟帖： 

• 谢天谢地。Paxlovid是今年圣诞最好的礼物。可以减少90%重症和死亡，对O变也有效。希望及早问世 -fuz- ♂ (0 bytes) () 12/22/2021 postreply 09:48:43

• 上个月，美国已经花5.3B 预购了一千万个疗程的用药。不知花落谁家 -fuz- ♂ (185 bytes) () 12/22/2021 postreply 10:28:23

• FDA 关于Paxlovid的 emergency use authorization (EUA) 全文LINK。。 -pickshell- ♀ (296 bytes) () 12/22/2021 postreply 10:14:13

• 嘿嘿，那个是新闻公告，东拉西扯杂货太多。这个才是EUA -fuz- ♂ (131 bytes) () 12/22/2021 postreply 10:18:51

• 唉，这不就是FDA那LINK下Related Information里内容么？欲读更多细节下面还有FAQ。 -pickshell- ♀ (0 bytes) () 12/22/2021 postreply 10:49:24

• 疫苗和药物都是试验品，有这么多人抢着参与生化实验，这么信任这些赚大钱的公司和政府机构吗 -yanzi3- ♀ (0 bytes) () 12/22/2021 postreply 11:04:15

• Biontech CEO 和员工全部不打自己的疫苗 -yanzi3- ♀ (0 bytes) () 12/22/2021 postreply 11:57:27

• Link 不让贴，可以在 b itchute search到 -yanzi3- ♀ (0 bytes) () 12/22/2021 postreply 12:01:11

• 那个CEO在年初打了二针疫苗 -fuz- ♂ (307 bytes) () 12/22/2021 postreply 12:30:17

• https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing -yanzi3- ♀ (202 bytes) () 12/22/2021 postreply 15:15:09

• 这种结果还敢打 -yanzi3- ♀ (0 bytes) () 12/22/2021 postreply 15:16:14

• https://www.thegatewaypundit.com/2021/12/oxford-study-shocker-1- -yanzi3- ♀ (325 bytes) () 12/22/2021 postreply 15:18:37

• 还有这个Oxford study -yanzi3- ♀ (0 bytes) () 12/22/2021 postreply 15:19:06

• 还真说对了。恐慌在先，疫苗和药物在后。 -AprilMei- ♀ (0 bytes) () 12/22/2021 postreply 12:10:53

• 请君入瓮，为了大家好 -julie116- ♀ (0 bytes) () 12/22/2021 postreply 15:52:47