Nov 16 (Reuters) - Pfizer Inc (PFE.N) said on Tuesday it is seeking U.S. authorization of its experimental antiviral COVID-19 pill that cut the chance of hospitalization or death for adults at risk of severe disease by 89% in a clinical trial.
Pfizer on Tuesday said it is seeking Emergency Use Authorization for the antiviral pill, called Paxlovid, from the Food and Drug Administration. Earlier this month, the company said Paxlovid cut the risk of hospitalization and death by nearly 90% in people with mild to moderate coronavirus infections.
……………
"The overwhelming efficacy achieved in our recent clinical study of Paxlovid, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19," Pfizer CEO Albert Bourla said in a statement.
………、
Other drugmakers are also developing a pill to treat COVID-19. An FDA panel is scheduled to meet on November 30 to weigh a potential emergency use authorization for molnupiravir, an antiviral drug developed by Merck and Ridgeback Biotherapeutics that recently won authorization in the United Kingdom.
Merck says its drug, called molnupiravir, halved the risk that adult COVID-19 patients with underlying health conditions ended up in the hospital or died from the disease.
Both Merck's and Pfizer's antiviral drugs are swallowed in capsules for five days starting soon after higher-risk patients test positive for the virus. Both pills are designed to reduce the risk of severe disease in the early days after infection, but they work in different ways.
Biden administration to buy Pfizer antiviral pills for 10 million people, hoping to transform pandemic
The Biden administration is planning to purchase 10 million courses of Pfizer’s covid pill, a $5 billion investment in a treatment that officials think will help change the trajectory of the coronavirus pandemic by reducingsevere illnessand deaths
The scheduled interim analysis showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset (primary endpoint); 0.8% of patients who received PAXLOVID™ were hospitalized through Day 28 following randomization (3/389 hospitalized with no deaths), compared to 7.0% of patients who received placebo and were hospitalized or died (27/385 hospitalized with 7 subsequent deaths). The statistical significance of these results was high (p<0.0001).
Similar reductions in COVID-19-related hospitalization or death were observed in patients treated within five days of symptom onset; 1.0% of patients who received PAXLOVID™ were hospitalized through Day 28 following randomization (6/607 hospitalized, with no deaths), compared to 6.7% of patients who received a placebo (41/612 hospitalized with 10 subsequent deaths), with high statistical significance (p<0.0001).
In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 (1.6%) deaths in patients who received placebo.
安全性： 请注意，对照组的副作用比用药组还多。
Study Safety Data
The review of safety data included a larger cohort of 1881 patients in EPIC-HR, whose data were available at the time of the analysis. Treatment-emergent adverse events were comparable between PAXLOVID™ (19%) and placebo (21%), most of which were mild in intensity. Among the patients evaluable for treatment-emergent adverse events, fewer serious adverse events (1.7% vs. 6.6%) and discontinuation of study drug due to adverse events (2.1% vs. 4.1%) were observed in patients dosed with PAXLOVID™ compared to placebo, respectively.
https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-files-us-authorization-covid-19-pill-2021-11-16/
Nov 16 (Reuters) - Pfizer Inc (PFE.N) said on Tuesday it is seeking U.S. authorization of its experimental antiviral COVID-19 pill that cut the chance of hospitalization or death for adults at risk of severe disease by 89% in a clinical trial.
https://www.cbsnews.com/news/covid-pill-pfizer-seeks-fda-authorization/
Pfizer on Tuesday said it is seeking Emergency Use Authorization for the antiviral pill, called Paxlovid, from the Food and Drug Administration. Earlier this month, the company said Paxlovid cut the risk of hospitalization and death by nearly 90% in people with mild to moderate coronavirus infections.
……………
"The overwhelming efficacy achieved in our recent clinical study of Paxlovid, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19," Pfizer CEO Albert Bourla said in a statement.
………、
Other drugmakers are also developing a pill to treat COVID-19. An FDA panel is scheduled to meet on November 30 to weigh a potential emergency use authorization for molnupiravir, an antiviral drug developed by Merck and Ridgeback Biotherapeutics that recently won authorization in the United Kingdom.
Merck says its drug, called molnupiravir, halved the risk that adult COVID-19 patients with underlying health conditions ended up in the hospital or died from the disease.
Both Merck's and Pfizer's antiviral drugs are swallowed in capsules for five days starting soon after higher-risk patients test positive for the virus. Both pills are designed to reduce the risk of severe disease in the early days after infection, but they work in different ways.
https://www.washingtonpost.com/health/2021/11/16/administration-purchases-pfizer-anti-covid-pill/
Biden administration to buy Pfizer antiviral pills for 10 million people, hoping to transform pandemicThe Biden administration is planning to purchase 10 million courses of Pfizer’s covid pill, a $5 billion investment in a treatment that officials think will help change the trajectory of the coronavirus pandemic by reducing severe illness and deaths
从昨天午饭后就越来越难受，肌肉关节疼痛，头也昏沉沉的，发冷但没有温度，就干脆躺平，总共吃了三次泰偌，睡前吃泰偌PM，半夜睡睡醒醒，盗汗。早上好些了，起来吃早饭喝咖啡增加能量。
PF-07321332 和 ritonavir
https://en.wikipedia.org/wiki/PF-07321332 Formula: C23H32F3N5O4 https://en.wikipedia.org/wiki/Ritonavir Formula: C37H48N4O5 ritonavir治疗艾滋病药.俺家那位，比你早打几小时。
到现在，啥全身症状都没有，一点不发烧。
针眼那块儿，有点疼，第二天早上啥事没有。在院子里收了半天树叶。
前二针也是一样，啥毛病都没有。
劳动人民比较抗造。
在学校的疫苗中心打的，疫苗不应该有啥问题啊。
https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate
有效性
The scheduled interim analysis showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset (primary endpoint); 0.8% of patients who received PAXLOVID™ were hospitalized through Day 28 following randomization (3/389 hospitalized with no deaths), compared to 7.0% of patients who received placebo and were hospitalized or died (27/385 hospitalized with 7 subsequent deaths). The statistical significance of these results was high (p<0.0001).
Similar reductions in COVID-19-related hospitalization or death were observed in patients treated within five days of symptom onset; 1.0% of patients who received PAXLOVID™ were hospitalized through Day 28 following randomization (6/607 hospitalized, with no deaths), compared to 6.7% of patients who received a placebo (41/612 hospitalized with 10 subsequent deaths), with high statistical significance (p<0.0001).
In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 (1.6%) deaths in patients who received placebo.
安全性： 请注意，对照组的副作用比用药组还多。
Study Safety Data
The review of safety data included a larger cohort of 1881 patients in EPIC-HR, whose data were available at the time of the analysis. Treatment-emergent adverse events were comparable between PAXLOVID™ (19%) and placebo (21%), most of which were mild in intensity. Among the patients evaluable for treatment-emergent adverse events, fewer serious adverse events (1.7% vs. 6.6%) and discontinuation of study drug due to adverse events (2.1% vs. 4.1%) were observed in patients dosed with PAXLOVID™ compared to placebo, respectively.