Multicultural thinking

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

Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in AdolescentsUploaded 16-08-22https://www.preprints.org/manuscript/202208.0151/v1Study focuses on cardiovascular effects, particularly myocarditis and pericarditis events, after BNT162b2 mRNA COVID-19 vaccine injection,in Thai adolescents, 13 to 18, both sexes This prospective cohort study,students from two schools aged 13–18 years,who received the second dose of the BNT162b2 vaccine. All healthy and without any abnormal symptoms before receiving the second dose of vaccine. Data collectedDemographicsSymptomsVital signsECG, echocardiographyCardiac enzymesCollected at baseline, Day 3, Day 7, and Day 14N = 314Analysis, n = 301Cardiovascular effectsFound in 29.24% of patients,ranging from tachycardia, palpitation, and myopericarditis. Most common cardiovascular effectsTachycardia, 7.64%Shortness of breath, 6.64%Palpitation, 4.32%Chest pain, 4.32%Hypertension, 3.99%Abnormal ECG finding, 54 patients (17.94%) Seven participants (2.33%)(all male)At least one elevated cardiac biomarker or positive lab assessmentsMyopericarditisConfirmed in one patient after vaccination. Two patients had suspected pericarditisFour patients had suspected subclinical myocarditis Three patients had minimal pericardial effusion Myocarditis and Sudden Cardiac Death in the Younghttps://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.107.693085Myocarditis accounts for up to 20% of sudden cardiac deaths in young adults. During the follow-up period, (14 days)After receiving the second dose of vaccine, two patients were hospitalized,one patient was supervised in the ICU during hospitalization, (mainly for observation of arrhythmia).ConclusionThe clinical presentation of myopericarditis after vaccination was usually mild, with all cases fully recovering within 14 days. Hence, adolescents receiving mRNA vaccines should be monitored for side effects. Clinical Trial Registration: NCT05288231Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and reviewhttps://www.bmj.com/content/378/bmj-2021-069445Male adolescents and male young adults are at the highest risk of myocarditis after an mRNA vaccination.https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.htmlVaccines for COVID-19COVID-19 vaccines are safe, effective, and free.COVID-19 Vaccines for Children and Teenshttps://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.htmlCDC recommends covid -19 vaccines for everyone 6 months and older and boosters for everyone 5 years and older, Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices

G20 Bali Leaders’ Declaration

The War on Ivermectin by Dr. Pierre Kory, https://www.amazon.com/War-Ivermectin-Medicine-Millions-Pandemic/dp/151077386X/ref=sr_1_1?dib=eyJ2IjoiMSJ9.EVlbDojnY-TDtm3BgepTIg.q5qDUxkwO3stZL9DZRUFMVYBLM5ix5BlzBT_LKusDLA&dib_tag=se&keywords=kory+the+war+on+ivermectin&qid=1762207712&sr=8-1 COVID-19 treatment: real-time analysis of 6,252 studies, https://c19early.org/ Learn more about your ad choices. Visit megaphone.fm/adchoices

Clip from talk with Neil Oliver, Tim Kelly and John Campbell. Times and opinions have changed.Check out Neil's channel as well, https://www.youtube.com/@Neil-OliverFollow Tim on X, https://x.com/DrTimothyKelly Uploaded 16-06-25Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices