The British Medical Journal (BMJ) is demanding pharmaceutical companies release raw COVID-19 vaccine data. BMJ Editors Peter Doshi, Fiona Godlee, and Kamran Abbasi published an editorial stating that “data should be fully and immediately available for public scrutiny” adding that much of the data from major vaccine manufacturers cannot be accessed because the vaccinations are not approved by the Food and Drug Administration.
The FDA is only producing data for Pfizer’s vaccine as both Moderna and Johnson & Johnson’s vaccines are not approved by the FDA, despite the popular misconception that they are. Rather, the latter pair have “Emergency Authorization Use,” status, rather than FDA approval.
Initially, the FDA said it was willing to release 500 pages of data per month. A judge in Texas rejected this offer, ordering the entity release 55,000 pages of the data the FDA used to license Pfizer’s vaccine.
At present, Pfizer “has indicated that it will not begin entertaining requests for trail data until May 2025,” some two years after the primary study completion. Moderna may release data at some point this year, but not before trials are complete. The estimated completion data for Moderna’s study trial review and completion is October 27 2022.
The BMJ called the refusal to release data an “unacceptable delay” and “morally indefensible.” The editorial continues, “We are left with publications but no access to the underlying data on reasonable request. This is worrying for trial participants, researchers, clinicians, journal editors, policy makers, and the public.”
“…Big Pharma is the least trusted industry. At least three of the many companies making COVID-19 vaccines have past criminal and civil settlements costing them billions of dollars. One pleaded guilty to fraud… now, the COVID pandemic has minted many new pharma billionaires.”
The BMJ editorial leans heavily into how these actions have led to a lack of public, academic, and scientific trust in both Big Pharma and the COVID-19 vaccines. “We need complete data transparency for all studies, we need it in the public interest, and we need it now.”
The editorial compares the current lack of access to data with the Tamiflu drug stockpiling a decade ago. The authors describe how during the last influenza outbreak, Tamiflu had not been shown to reduce the risk of complications, hospital admissions, and death from the virus, similarly to preliminary studies of the COVID-19 vaccination.
Trials for the efficacy of Tamiflu were sponsored by the manufacturer, and went unpublished. Those papers that were released were done so without author access to raw data. Academics demanding access were denied. The same thing is happening with the clinical trial and raw data held by Pfizer, Moderna, AstraZeneca, and Johnson & Johnson of their COVID-19 vaccines and clinical trials.
Authored by Kay Smythe via The National Pulse
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