Vaccines and data transparency

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Transparency of COVID-19 vaccine trials: decisions without data
Transparency of COVID-19 vaccine trials: decisions without data
### Summary box Access to data for drugs and vaccines has historically been fairly limited to journal article publications and hard-to-access and difficult to read regulatory reports.1 But the past decade has witnessed strides in clinical trial data transparency. A wide range of institutions, from pharmaceutical companies, government agencies, trade organisations, journals and not-for-profit organisations, have all acknowledged the importance of data sharing, including the release of deidentified individual participant data. Many policies, regulations and platforms now exist to facilitate data access, including landmark transparency policies from the European Medicines Agency (EMA)2 3 and Health Canada.4 Both regulators now post on their websites, sections of the licensure dossier received by the industry (https://clinicaldata.ema.europa.eu/ and https://clinical-information.canada.ca/). There are also industry and academic platforms to facilitate third-party access to trial data and documents, including ClinicalStudyDataRequest.com, Yale University Open Data Access (YODA) Project and Vivli.5 In 2013, the US and European industry trade organisations endorsed a joint statement on clinical trial data sharing, making a series of commitments that ‘recognise the importance of sharing clinical trial data in the …
·ebm.bmj.com·
Transparency of COVID-19 vaccine trials: decisions without data
Dr Malhotra on calling for vaccine data transparency: 'The information has evolved considerably'
Dr Malhotra on calling for vaccine data transparency: 'The information has evolved considerably'
'Everything we had to go on at the beginning was based upon that figure which was exaggerated in terms of its benefits... the information has evolved since then, considerably.' Dr Aseem Malhotra joins Mark Steyn to discuss why he's calling for greater vaccine data transparency. Watch on TV: Freeview 236, Sky 515, Virgin 626 Listen on DAB+ Radio Download the GB News App to watch live wherever you are, catch up with all our shows and get the latest news from the GBN family. https://www.gbnews.uk/freegbapp Don't forget to follow us on social media too! Twitter: https://twitter.com/GBNEWS Facebook: https://www.facebook.com/GBNewsOnline Instagram: https://www.instagram.com/gbnewsonline/ LinkedIn: https://www.linkedin.com/company/gb-news/ TikTok: https://www.tiktok.com/@gbnews Click here for the latest Covid-19 guidance from the World Health Organisation ► https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public Click here for the latest NHS information on COVID-19 vaccines https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/
·youtube.com·
Dr Malhotra on calling for vaccine data transparency: 'The information has evolved considerably'
FDA Seeks to Hide Pfizer’s Documents From the Public - ICAN - Informed Consent Action Network
FDA Seeks to Hide Pfizer’s Documents From the Public - ICAN - Informed Consent Action Network
ICAN’s lead attorney, Aaron Siri, is representing a broad group of scientists from major universities across the country in a lawsuit seeking to obtain the documents Pfizer provided the FDA to license its COVID-19 vaccine. As you may have seen, the FDA’s response was to ask the judge for a total of 55 years to fully produce these documents!
·icandecide.org·
FDA Seeks to Hide Pfizer’s Documents From the Public - ICAN - Informed Consent Action Network
The Problem with Current Vaccine Trials: What Journalists Need to be Asking Drug Companies
The Problem with Current Vaccine Trials: What Journalists Need to be Asking Drug Companies
People around the world believe the several promising COVID-19 vaccines were designed to do the two things we most want them to do: reduce severe illness and death, and reduce the spread of the disease. But a central problem, experts say, is that none of the new vaccine trials were designed to achieve either of those goals.
·gijn.org·
The Problem with Current Vaccine Trials: What Journalists Need to be Asking Drug Companies
Covid-19 vaccines and treatments: we must have raw data, now
Covid-19 vaccines and treatments: we must have raw data, now
Data should be fully and immediately available for public scrutiny In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.1234 The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data.56 Public battles for drug company data,78 transparency campaigns with thousands of signatures,910 strengthened journal data sharing requirements,1112 explicit commitments from companies to share data,13 new data access website portals,8 and landmark transparency policies from medicines regulators1415 all promised a new era in data transparency. Progress was made, but clearly not enough. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come.16 This is morally indefensible for all trials, but especially for those involving major public health interventions. Pfizer’s pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial …
·bmj.com·
Covid-19 vaccines and treatments: we must have raw data, now
Israeli Government Lied and Covered Up Long-Lasting Harmful Effects of Covid Injections and Corporate Media Refuses to Cover the Story
Israeli Government Lied and Covered Up Long-Lasting Harmful Effects of Covid Injections and Corporate Media Refuses to Cover the Story
by Rhoda Wilson In an article published yesterday, Steve Kirsch detailed the proof that Israel found serious safety problems with the Covid “vaccines” and then deliberately covered it up. “Israel didn’t start to gather safety data until a year into the vaccine program. They gathered 6 months’ worth of data and found that the vaccines weren’t safe so they lied to the world about it,”
·2ndsmartestguyintheworld.com·
Israeli Government Lied and Covered Up Long-Lasting Harmful Effects of Covid Injections and Corporate Media Refuses to Cover the Story
We Now Have Clear Proof the Vaccine is Dangerous and That The CDC Concealed It
We Now Have Clear Proof the Vaccine is Dangerous and That The CDC Concealed It
Aaron Siri was finally able to force the CDC to relinquish their V-safe data, which showed over 10% of recipients suffered significant adverse reactions to vaccination. This article will explain why that is so important. Introduction One of the major challenges with the COVID-19 vaccination has been that it has been impossible to get any clear safety data on it. The two key issues have been:
·midwesterndoctor.com·
We Now Have Clear Proof the Vaccine is Dangerous and That The CDC Concealed It
COVID vaccine safety. Transparency
COVID vaccine safety. Transparency
We reported earlier that the Food & Drug Administration wanted to wait 55 years before sharing the data it relied upon in licensing Pfizer’s COVID-19 vaccine, an act that in turn paved the way for vaccine mandates. Even Reuters prepared an article asking, “Wait what?”, and reported that lawyer Aaron Siri, involved in legal action to acquire this data, notes that it took only 108 days for the “FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s COVID-19 vaccine”.
·okaythennews.substack.com·
COVID vaccine safety. Transparency
Wait what? FDA wants 55 years to process FOIA request over vaccine data
Wait what? FDA wants 55 years to process FOIA request over vaccine data
Freedom of Information Act requests are rarely speedy, but when a group of scientists asked the federal government to share the data it relied upon in licensing Pfizer’s COVID-19 vaccine, the response went beyond typical bureaucratic foot-dragging.
·reuters.com·
Wait what? FDA wants 55 years to process FOIA request over vaccine data