Show Notes
Is this antiviral a game changer, Oral Antiviral, molnupiravir Uploaded 03-10-21https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/Merck and RidgebackOral Antiviral, molnupiravir (MK-4482, EIDD-2801)Positive Interim Analysis of Phase 3 StudySignificantly reduced the risk of hospitalization or deathDuring day 1 to 5 to 29 daysPhase 3 MOVe-OUT trial At risk, non-hospitalized adults with mild-to-moderate COVID-19 A global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patientsBrazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United StatesEligibility criteriaLaboratory-confirmed mild-to-moderate COVID-19With symptom onset within 5 days of study randomizationAll patients were required to have at least one risk factorMolnupiravir groupHospitalization or dead, 7.3% of patients28 out of 385No deathsPlacebo groupHospitalization or dead, 14.1% of patients53 out of 377P is 0.00128 deathsData Monitoring Committee in consultation with Food and Drug AdministrationRecruitment into the study stopped early Due to these positive resultsMerck, application for Emergency Use Authorization in USOther regulatory bodies worldwideAbout the Results of the Planned Interim AnalysisEvaluated data n = 775Recruitment 90% of 1,550 the intended sample Molnupiravir reduced the risk of hospitalization and/or death across all key subgroups; Efficacy was not affected by timing of symptom onset or underlying risk factorAbout 40% of participants had sequencing dataMolnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and MuIncidence of adverse event between groupsMolnupiravir groupIncidence of any adverse event, 35%Drug-related adverse events, 12%Subjects discontinued study therapy due to an adverse event, 1.3%Placebo groupsIncidence of any adverse event, 40%Drug-related adverse events, 11%Subjects discontinued study therapy due to an adverse event, 3.4%Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from intercourse or agree to use contraception. Women of child-bearing age in the study could (not) be pregnant and also had to use birth control.https://www.reuters.com/business/healthcare-pharmaceuticals/mercks-covid-19-pill-cuts-risk-death-hospitalization-by-50-study-2021-10-01/About Merck’s Efforts to Enable Access to Molnupiravir, if it is Granted EUA or ApprovalMerck has been producing molnupiravir at risk. Merck expects to produce 10 million courses of treatment by the end of 2021Existing procurement agreement with the U.S. GovernmentMerck will supply approximately 1.7 million courses of molnupiravir to the U.S. government upon EAU$700 per 5 day course (2 doses per day)$1.2 billion purchase agreement for the 1.7 million 5-day treatment courses of molnupiravir MOVe-AHEADA global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices
More from Dr. John Campbell
If you live in the UK, you can contact your MP using this link, https://www.parliament.uk/get-involved/contact-an-mp-or-lord/contact-your-mp/Uploaded 19-10-23Watch the debate live, https://www.parliamentlive.tv/Event/Index/00961342-e42c-431c-b26b-fda858dba69b Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices
Rise of natural acquired immunityUploaded 01-09-22Get additional scientific background from John’s free text books,http://159.69.48.3/(you will need to cut and paste this link into your browser)Risk of BA.5 Infection among Persons Exposed to Previous SARS-CoV-2 Variantshttps://www.nejm.org/doi/full/10.1056/NEJMc2209479?query=TOC&cid=NEJM%20eToc,%20September%201,%202022%20DM1402792_NEJM_Non_Subscriber&bid=1141953912https://www.nejm.org/doi/suppl/10.1056/NEJMc2209479/suppl_file/nejmc2209479_appendix.pdfOmicron subvariants, BA.1 and BA.2, displaced by BA.5 in many countriesGreater transmissibilityPartial evasion of BA.1- and BA.2-induced immunityPortugal, one of the first countries affected by a BA.5 predominanceN = 9,307,996All Portuguese residents aged 12 years and older, (National Census 2021) Uninfected people in June 1st 2022 was 5, 328, 287, (57% of the Portuguese population over 12) (PCR tests and rapid antigen tests to diagnose cases) Presence of undocumented infections among the “uninfected” group of individuals 29.2% of infections were not notified(based on the seroprevalence of SARS-CoV-2 anti-N IgG in the population) National coronavirus disease 2019 registry (SINAVE)(all reported cases in the country, regardless of clinical presentation)To calculate the risk of BA.5 infection after documented infection with past variants, including BA.1 and BA.2Times when different variants represented more than 90% of the isolatesTo calculate their infection risk during the period of BA.5 dominancePooled BA.1 and BA.2 (slow transition between the two subvariants)Comparator groupPopulation that did not have any documented infection before BA.5 dominance (June 1, 2022)ResultsWuhan-Hu-1 55.7%Alpha 58.8%Delta 64.5%BA.1 / BA.2 7 6.8%We found that previous SARS-CoV-2 infection had a protective effect against BA.5 infectionProtection was maximal for previous infection with BA.1 or BA.2 (not suprising)ContextPortugal more than 98% of the study population completed the primary vaccination series before 2022There is a perception that the protection afforded by previous BA.1 or BA.2 infection is very low, given the high number of BA.5 infections among persons with previous BA.1 or BA.2 infection. Our data indicate that this perception is probably a consequence of the larger pool of persons with BA.1 or BA.2 infection than with infection by other subvariants, and it is not supported by the data.Breakthrough infections with the BA.5 subvariant were less likely among persons with a previous SARS-CoV-2 infection history … especially for previous BA.1 or BA.2 infection, than among uninfected persons. Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices
Professor Angus Dalgleish, physician, oncologist, pathologist, medical researcher and author. Get your copy of The Death of Science, https://gazellebookservices.co.uk/pro...Uploaded 21-02-24Also by Professor Dalgleish, The Origin of the Virus: The hidden truths behind the microbe that killed millions of people, https://www.amazon.co.uk/dp/185457106... Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices
Link to but the book, https://covidthroughoureyes.com.au/products/covid-through-our-eyes-an-australian-story-of-mistakes-mistreatment-and-misinformation Letters from Australia is Alison Bevege's Substack, https://lettersfromaustralia.substack.com/ Learn more about your ad choices. Visit megaphone.fm/adchoices