Paxlovid evidence base

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Paxlovid, it this an evidence based intervention in May 2022? • Paper FDA EMU was based on • https://www.nejm.org/doi/full/10.1056... • EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) • 1120 patients received nirmatrelvir plus ritonavir • 1126 received placebo • Relative risk reduction • Risk of progression to severe Covid-19, 89% lower than the risk with placebo • Absolute risk reduction • https://www.precisionvaccinations.com... • 7% down to 1% • symptomatic, unvaccinated, non hospitalized adults • at high risk for progression to severe coronavirus disease 2019 • July 16 and December 9, 2021 • If vaccinated people and previously infected people are partly protected • More people would need to be treated to prevent one adverse event • Pfizer press release (5th November 2021) • https://www.pfizer.com/news/press-rel... • our oral antiviral candidate, … has the potential to save patients’ lives, • reduce the severity of COVID-19 infections, • and eliminate up to nine out of ten hospitalizations • Pfizer Shares In Vitro Efficacy of Novel COVID-19 Oral Treatment Against Omicron Variant • https://www.pfizer.com/news/press-rel... • https://www.yalemedicine.org/news/12-... • https://www.fda.gov/media/155051/down... • The results showed in all cases that nirmatrelvir was a potent inhibitor of its target. • PAXLOVID™ for Post-Exposure Prophylactic Use • https://www.pfizer.com/news/press-rel... • Evaluated data from 2,957 adults • Pfizer observed risk reductions of 32% (5 day course) • 37% reduction (10 day course) • These results, however, were not statistically significant and, as such, the primary endpoint of reducing the risk of confirmed and symptomatic COVID-19 infection in adults who had been exposed to the virus through a household contact was not met. • • • FACT SHEET FOR PATIENTS, PARENTS, AND CAREGIVERS • EMERGENCY USE AUTHORIZATION (EUA) OF PAXLOVID FOR CORONAVIRUS DISEASE 2019 (COVID-19) • https://www.fda.gov/media/155051/down... • PAXLOVID is not an FDA-approved medicine in the United States. • PAXLOVID is an investigational medicine • Some medicines may interact with PAXLOVID and may cause serious side effects. • If you take too much PAXLOVID, call your healthcare provider or go to the nearest hospital emergency room right away. • Possible side effects of PAXLOVID are: • Allergic Reactions • trouble swallowing or breathing, swelling of the mouth, lips, or face, throat tightness, hoarseness, skin rash • Liver Problems. Tell your healthcare provider right away, • loss of appetite, yellowing of your skin and the whites of eyes (jaundice), dark-colored urine, pale colored stools and itchy skin, stomach area (abdominal) pain. • Other possible side effects include: • altered sense of taste, diarrhea, high blood pressure, muscle aches • Dr. Ashish K. Jha, White House, Covid-19 coordinator • The new White House Covid czar says avoiding all virus infections isn’t the goal of U.S. pandemic policy. • Paxlovid, push to reach the vulnerable • Doctors are too hesitant to prescribe the drug • https://en.wikipedia.org/wiki/Ashish_Jha • Senior Advisor at Albright Stonebridge Group • https://www.politico.com/newsletters/... • The firm advises clients on international policy and global markets • Patrick Vallance • From 2012 to 2018, he was President of Research and Development at global pharmaceutical company, GlaxoSmithKline (GSK) • https://www.telegraph.co.uk/news/2020... • Cashed £5,000,000 GSK shares • Future jobs of FDA’s haematology-oncology reviewers • https://www.bmj.com/content/354/bmj.i... • https://www.npr.org/sections/health-s... • More than a quarter of the Food and Drug Administration employees • (who approved cancer and hematology drugs from 2001 through 2010) • left the agency and now work or consult for pharmaceutical companies,

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