Channel: Dr. John Campbell

Category: Education

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Description: Paxlovid, it this an evidence based intervention in May 2022? Paper FDA EMU was based on nejm.org/doi/full/10.1056/NEJMoa2118542 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 precisionvaccinations.com/what-paxlovids-absolute-and-relative-covid-19-risk-reduction 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) pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate 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 pfizer.com/news/press-release/press-release-detail/pfizer-shares-vitro-efficacy-novel-covid-19-oral-treatment yalemedicine.org/news/12-things-to-know-paxlovid-covid-19 fda.gov/media/155051/download The results showed in all cases that nirmatrelvir was a potent inhibitor of its target. PAXLOVID™ for Post-Exposure Prophylactic Use pfizer.com/news/press-release/press-release-detail/pfizer-shares-top-line-results-phase-23-epic-pep-study 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) fda.gov/media/155051/download 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 en.wikipedia.org/wiki/Ashish_Jha Senior Advisor at Albright Stonebridge Group politico.com/newsletters/transition-playbook/2021/03/23/the-blob-abides-492214 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) telegraph.co.uk/news/2020/09/23/revealed-sir-patrick-vallance-has-600000-shareholding-firm-contracted Cashed £5,000,000 GSK shares Future jobs of FDA’s haematology-oncology reviewers bmj.com/content/354/bmj.i5055.full npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry?t=1651600609470 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,