Nothing to hide? The quest for transparency on Covid-19 vaccines
The Public Health and Medical Professionals for Transparency initiative and a key Citizen Petition with the Food and Drug Administration.
Once upon a time, before they could hit the market new drugs and biologics had to undergo a lengthy and complex procedure. For new vaccines, the process was notoriously long. As they are given to otherwise healthy individuals, their safety and efficacy profile must be especially advantageous. We described in layperson language how that used to work in the Guide Investigating Health and Medicine we wrote on commission for the Global Investigative Journalism Network.
The Covid-19 crisis has seemingly changed things for good. Several vaccines have been developed and authorised for emergency use (Emergency Use Authorization or EUA) at warp speed. The so-called “Fast Track” process, widely criticised in the past for offering a convenient short cut to pharmaceutical companies, has become the new normal. Pointing at its well-known shortcomings will now expose you to being labeled as conspiracy theorist, anti-vaxxer, you name it.
However, scientists and doctors have been pointing at the many risks that come with rushing the approval process. Transparency on data - on those filed for approval, and on those collected afterwards - is of paramount importance. Such basics are even more relevant when it’s about Covid-19 vaccines. They have been hailed by news organisations and governments as miracle biologics. Nevertheless, praise was unfailingly based on companies’ press releases. In 2020, a first look at vaccines’ study design showed that it would have been difficult to know if they could actually deliver what headlines promised and in 2021, a piece published by BMJ-EBM nailed it: Transparency of COVID-19 vaccine trials: decisions without data is a must read.
In September 2021 a non-profit initiative was launched and Re-Check has joined it from day one. Public Health and Medical Professionals for Transparency has been fighting in US courts for the Food and Drug Administration (FDA) to release all data related to its approval of the Pfizer-BioNTech Covid-19 vaccine. Why are we trying so hard to obtain this specific vaccine’ documents? As explained by The BMJ in this feature, “other manufacturers’ data cannot be requested until the vaccines are approved, which the Moderna and Johnson & Johnson vaccines are not. Industry, which holds the raw data, is not legally required to honour requests for access from independent researchers”.
Four days after the Pfizer vaccine was approved for ages 16+, we submitted a Freedom of Information Act Request to the FDA for all of the data within Pfizer’s COVID-19 vaccine biological product file. We have consequently sued the FDA for not releasing the data. The US regulatory agency offered to release 500 pages a month, a process that would take about 75 years to complete, with the result that we’d have access to the full dataset by... 2097. However, a federal judge rejected the FDA’s offer and ordered the data be released at a rate of 55 000 pages a month. You can find all information about this ongoing fight for transparency on the initiative website and all FDA-released data are published in real-time on the platform. Most recent developments in plain language are to be found on Aaron Siri’s, one of our attorneys, Substack and on his Twitter account @AaronSiriSG. In January 2023, there was another crucial step for transparency in the public interest: a Citizen Petition was filed with the FDA requesting the agency to update mRNA Covid vaccines labeling. The petition outlines 10 safety and efficacy concerns you definitely want to know about. Read here all the details.
#Feature: The Novavax’s saga
It’s an iconic story for some of the bizarre developments that are flabbergasting many people that are into science, medicine and regulation. Like its competitor Moderna, the Maryland US biotech company Novavax had never brought before a single product to the market. And yet, it announced its magic bullet against Sars-CoV-2 already in January 2020. Read what happened behind the scenes of one the most waited vaccines in this open access investigative piece.
Covid-19: Whatever happened to the Novavax vaccine?
By Catherine Riva, Serena Tinari
#OnTheRoad: long-format interview with Anti | thèse
Long format and uncut. Martin Bernard and Ouriel Barbezat of Anti | thèse interviewed us for over two hours and the result is online, in open access. We talked about #PandemicJournalism out of control, #Covid19 evidence-free policies, social media censorship, the shameful silencing of critical voices, the smearing campaign against real experts, the concerning function creep potential of the Covid certificates, how science and regulation used to work - imperfect but in hindsight reasonable - before over two years of madness.
And much more. In French.
#GIJNHealthGuide: The Guide Investigating Health and Medicine we wrote on commission for the Global Investigative Journalism Network is now available in: English, French, Russian, Italian, and Spanish. The Guide is published under Creative Commons License and can therefore be freely reproduced and distributed after getting in touch with GIJN (firstname.lastname@example.org) or with us (email@example.com).
Pandemic Re-Check’s Series: Journalism in pandemic mode: embedded, complacent and unable to inform democratic debate; Science in Pandemic Mode: The Strange Case of the Swiss National COVID-19 Science Task Force; Democracy in Pandemic Mode: the Strange Case of the COVID Certificate; Function creep in pandemic mode: the strange case of the Covid-19 certificates.
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#GoodReads: five for each edition
Lead author of new Cochrane review speaks out. A no-holds-barred interview with Tom Jefferson. By Maryanne Demasi.
Tom Jefferson, senior associate tutor at the University of Oxford, is the lead author of a recent Cochrane review that re-ignited one of the most divisive debates during the pandemic - face masks. The updated review titled “Physical interventions to interrupt or reduce the spread of acute respiratory viruses” found that wearing masks in the community probably makes little or no difference to influenza-like or covid-19-like illness transmission. Jefferson and his colleagues also looked at the evidence for social distancing, hand washing, and sanitising/sterilising surfaces -- in total, 78 randomised trials with over 610,000 participants. In this exclusive interview, Jefferson didn’t hold back. He condemned the pandemic’s “overnight experts”, he criticised the multitude of scientifically baseless health policies, and even opened up about his disappointment in Cochrane’s handling of the review.
Read it on Maryanne Demasi’s Substack.
The Masking of the Servant Class: Ugly COVID Images From the Met Gala Are Now Commonplace. By Glenn Greenwald.
“The normalization of maskless elites attended to by faceless servants is grotesque”. A thought-provoking and well-resourced essay.
Substack. September 14, 2021.
Read it on Glenn Greenwald's Substack.
“This Shouldn’t Happen”: Inside the Virus-Hunting Nonprofit at the Center of the Lab-Leak Controversy. By Katherine Eban.
Chasing scientific renown, grant dollars, and approval from Dr. Anthony Fauci, Peter Daszak transformed the environmental nonprofit EcoHealth Alliance into a government-funded sponsor of risky, cutting-edge virus research in both the U.S. and Wuhan, China. Drawing on more than 100,000 leaked documents, a Vanity fair investigation shows how an organization dedicated to preventing the next pandemic found itself suspected of helping start one. Disclosure: Katherine Eban, author of this investigation, is a member of Re-Check’s Advisory Board.
The Twitter Files. Multiple independent journalists have been given access to a trove of internal memos, chats and various communication the social media giant employees have entertained with governmental agencies, companies, and politicians. Censorship, black lists and much more, including some evidence on how Twitter collaborated to the creation of the Ministry of True Science in the Covid era. A Capsule Summaries of all Twitter Files Threads to Date, With Links and a Glossary, by Matt Taibbi, in open access on his Substack.
A plague chronicle. By eugyppius.
“We are witnessing an unprecedented, comprehensive failure of policy, medicine and science.” One of the best Substacks emerged in times of madness.
Good reads in open access and subscribers welcome, here.
Unerwünscht. By Mike Wyinger.
They decided to get the Covid-19 vaccine – some did it out of concerns about the virus. Others did it because their employers pressured them, and some did it because the government said that to get vaccinated was an act of solidarity. Eight Swiss that experienced serious side effects after Covid-19 vaccination speak up in these short films by Mike Wyniger.
Safe and Effective: A Second Opinion. By Mark Sharman, Oracles News.
This documentary shines a light on UK Covid-19 vaccine injuries and bereavements, but also scrutinises the systemic failings that appear to have enabled them.
Out to see. By Patricia Marchart.
Scientific freedom, the role of media, censorship. And about Covid in a long interview with John Ioannidis. 75 minutes.
The arrogance of preventive medicine. By David L. Sackett.
“Preventive medicine displays all three elements of arrogance: it is aggressively assertive, is confident interventions will, on average, do more good than harm and is overbearing, attacking those who question the value of its recommendations.” Over twenty years old, and timely.
CMAJ. August 20, 2002.
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