Omicron fairness

Lots of data available from https://c19hcq.org/meta.html Great talk with Professor Robert Clancy on his latest publication on this well known drug. Learn more about your ad choices. Visit megaphone.fm/adchoices

For young healthy adults, MODERNA SUBMITS AMENDMENT TO THE EMERGENCY USE AUTHORIZATION FOR AN ADDITIONAL BOOSTER DOSE OF ITS COVID-19 VACCINE IN THE U.S.Uploaded 22-03-22(Pfizer, 65 and older for 4th shot)https://twitter.com/moderna_tx/status/1504628697894113285https://investors.modernatx.com/news/news-details/2022/Moderna-Submits-Amendment-to-the-Emergency-Use-Authorization-for-an-Additional-Booster-Dose-of-its-COVID-19-Vaccine-in-the-U.S/default.aspxrequest to the U.S. Food and Drug Administration,for an amendment to the emergency use authorization,to allow for a fourth dose of its COVID-19 vaccine (mRNA-1273),in adults 18 years of age and older who,have received an initial booster of any of the authorized or approved COVID-19 vaccines. (A booster dose of the Modern, 50 µg authorized for emergency use in the U.S. under EUA for adults 18 years and older)Clinical trials are ongoing for Moderna's Omicron-specific booster (mRNA-1273.529),and a bivalent Omicron-specific booster (mRNA-1273.214).QuestionsWill the 4th shot increase antibodies?Is it an emergency for a healthy 18 year old to get a 4th dose of vaccine today?Can beneficial endpoints be demonstrated for the individual?What n would be needed to demonstrate these beneficial outcomes?Will the 4th shot reduce T cell immunity for internal viral proteins?If someone has had omicron infection, will a 4th dose increase beneficial outcomes further?Is it time to end emergency shortcuts and get back to RCTS?Will there be guarantees a 4th dose will not be mandated once emergency use authorization is granted?Full FDA Approval of a COVID-19 Vaccine: What You Should Knowhttps://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/full-fda-approval-of-a-covid-19-vaccine-what-you-should-knowThe approval system for vaccines uses scientific data and exacting standards,to ensure safe and effective vaccinesReview processes includeClinical trialsThe FDA requires rigorous testing of vaccines through a series of clinical trials,to make sure they work and are safe before authorizing or approving them for the public. The laboratories that conduct the trials are independent from the vaccine companies and the government, process is not biased.Risks and benefitsmust demonstrate that the benefits of a vaccine are greater than its risks for those who will be vaccinatedContinual monitoringthe FDA may pause the administration of vaccine to do more studies,and ensure that the problem does not outweigh the vaccine’s benefit.Manufacturing guidelinestest the vaccine doses in batches (lots),to ensure the quality and effectiveness of the vaccines remain consistent and reliable.UK 4th Jabhttps://www.telegraph.co.uk/news/2022/03/20/fourth-covid-jabs-rolled-five-million-vulnerable-people-starting/?li_source=LI&li_medium=liftigniter-onward-journeyFourth Covid jabs to be rolled out to about five million vulnerable people starting from next weekThe Joint Committee on Vaccinations and Immunisations (JCVI)https://www.gov.uk/government/news/jcvi-advises-a-spring-covid-19-vaccine-dose-for-the-most-vulnerableAnother dose of Pfizer or Moderna, (six months after third dose)care home residentsover-75simmunosuppressed people over 12 years Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices

How to Prevent the Next Pandemic (Bill Gates)Uploaded 01-05-22If you would like John’s text books, (it is free to download the PDFs)http://159.69.48.3/by Bill Gates is published by Allen Lane at £25https://twitter.com/DrTedros/status/1515010722538954756https://www.dailymail.co.uk/news/article-10772223/Weve-not-seen-WORST-Covid-warns-Microsoft-billionaire-Bill-Gates.htmlhttps://www.telegraph.co.uk/books/what-to-read/bill-gatess-prevent-next-pandemic-triumph-systems-brain-feeling/It's not likely, I don't want to be a voice of doom and gloom, but it's way above a 5% risk that this pandemic, we haven't even seen the worst of itGlobal Epidemic Response and Mobilization initiativeShould be managed by the WHO,team of epidemiologists and computer modellers, dedicated, 2,000 to 3,000the only body capable, top-notch team of experts,$55bn a year globallystrengthening healthcare systems in low- and middle-income countrieseradication [of] whole families of respiratory disease, which would mean no more coronaviruses like Covid – and even better, no more flu https://www.wsj.com/articles/bill-gates-the-best-investment-ive-ever-made-11547683309https://www.gatesfoundation.org/ideas/articles/health-economist-global-health-financingWhat if we had invested $10 billion in energy projects in the developing world? In that case, the return would have been $150 billion. What about infrastructure? $170 billion. By investing in global health institutions, however, we exceeded all of those returns: The $10 billion that we gave to help provide vaccines, drugs, bed nets and other supplies in developing countries created an estimated $200 billion in social and economic benefits. Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial, Revelations of poor practices at a contract research companyhttps://www.bmj.com/content/375/bmj.n2635Uploaded 06-11-21Pfizer’s pivotal covid-19 vaccine trial, raise questions about data integrity and regulatory oversightThis was the original paperhttps://www.nejm.org/doi/full/10.1056/nejmoa2034577 Autumn 2020Pfizer’s chairman and chief executive, Albert BourlaAs I’ve said before, we are operating at the speed of scienceVentavia Research Grouphttps://www.ventaviaresearch.comResearchers were testing Pfizer’s vaccine at several sites in TexasA regional director, Brook Jackson has told The BMJ that the companyfalsified dataunblinded patientsemployed inadequately trained vaccinatorswas slow to follow up on adverse events reported in Pfizer’s pivotal phase III trialStaff who conducted quality control checks were overwhelmed by the volume of problems they were finding. US Food and Drug Administration (FDA) were informedVentavia fired her later the same day. The BMJ has been provided with dozens of internal company documents, photos, audio recordings, and emails.She repeatedly informed her superiorspoor laboratory managementpatient safety concernsdata integrity issuesthat drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel (later corrected)company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality controlICON, the contract research organisationhttps://www.iconplc.com/services/clinical-research-services/data-management/?creative=528047015643&keyword=small%20clinical%20research%20organizations&matchtype=b&network=g&device=c&campaignid=6471798703&adgroupid=124362508020&feeditemid=54055202224&adposition=&gclid=CjwKCAjwz5iMBhAEEiwAMEAwGB-tlgJ18Rir0V_YfW6YdQNvt33JmuRwwwZiAkL22Zh99BWJbYLb2xoCWKUQAvD_BwEICON then highlighted over 100 outstanding queries older than three daysWorries over FDA inspectionConcerns raisedParticipants placed in a hallway after injection and not being monitored by clinical staffLack of timely follow-up of patients who experienced adverse eventsProtocol deviations not being reportedVaccines not being stored at proper temperaturesMislabelled laboratory specimensTargeting of Ventavia staff for reporting these types of problems.FDA advisory committee meeting held on 10 December 2020Problems at Ventavia not mentionedThe next day the FDA issued the authorisation of the vaccine In August this year, after full FDA approval of Pfizer’s vaccineFDA published that 9 of the trials 153 sites were inspectedFDA, full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19Other employees’ accountseverything that you complained about was spot onTwo former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research communityI don’t think it was good clean dataIt’s a crazy messPfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trialscovid-19 vaccine in children and young adultspregnant womena booster dosean RSV vaccine trialNCT04816643, NCT04754594, NCT04955626, NCT05035212). Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices

Discussion about multicultural aspect of health care.Uploaded 01-10-23The Liger, Rex Soderlundhttps://theliger.substack.com/p/understanding-ecological-technologyWefwafwa’s channelhttps://www.youtube.com/@WefwafwaAndrew Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices