Coronavirus: Thread

grarpamp grarpamp at gmail.com
Sun Jan 23 01:16:27 PST 2022


British Medical Journal Demands Immediate Release of All COVID-19
Vaccine, Treatment Data

https://www.theepochtimes.com/british-medical-journal-demands-immediate-release-of-all-covid-19-vaccines-treatments-data_4227341.html

https://www.bmj.com/content/376/bmj.o102
https://clinicaltrials.gov/ct2/show/NCT04368728

https://www.theepochtimes.com/fda-says-it-now-needs-75-years-to-fully-release-pfizer-covid-19-vaccine-data_4145410.html
https://www.theepochtimes.com/judge-gives-fda-just-over-8-months-to-produce-pfizers-safety-data_4198409.html
https://www.theepochtimes.com/cdc-sued-for-withholding-post-licensure-v-safe-data-on-covid-19-vaccines_4186979.html
https://www.fdanews.com/articles/206113-federal-judge-tells-fda-it-must-make-public-55000-pages-a-month-of-pfizer-vaccine-data
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

The British Medical Journal (BMJ) has demanded the full and immediate
release of all data related to COVID-19 vaccines and treatments,
saying it is in the public’s interest to do so.

BMJ, a weekly peer-reviewed medical trade journal published by the
trade union the British Medical Association, called for the release of
the data in an editorial published on Wednesday.

    “Today, despite the global rollout of COVID-19 vaccines and
treatments, the anonymized 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,” BMJ said.

    “This is morally indefensible for all trials, but especially for
those involving major public health interventions.”

BMJ also accused pharmaceutical companies of “reaping vast profits
without adequate independent scrutiny of their scientific claims,”
pointing to Pfizer, whose COVID vaccine trial was “funded by the
company and designed, run, analyzed, and authored by Pfizer
employees.”

New York-headquartered Pfizer still holds that trial data and has
indicated that it won’t begin considering requests for such data until
May 2025—24 months after the primary study completion date of May 15,
2023, which is listed on ClinicalTrials.gov.

Meanwhile, The Food and Drug Administration (FDA) had asked a judge to
give it 75 years to produce all the data concerning the Pfizer and
BioNTech vaccine.

However, a judge earlier this month ordered that the FDA make public
12,000 pages of the data it used to make decisions regarding approvals
for the Pfizer/BioNTech COVID-19 vaccine by the end of the month. The
FDA must also release Pfizer’s vaccine data at a rate of 55,000 pages
a month until all of the requested pages are public.

BMJ also noted that AstraZeneca has indicated that it may be ready to
entertain requests for data from a number of its phase III trials.
However, the Cambridge-headquartered company says that the timeline
for such data can “vary per request and can take up to a year upon
full submission of the request for analysis, decision, anonymization,
and sharing of the requested data or documents.”

The Epoch Times has contacted spokespersons for Pfizer and AstraZeneca
for comment.

    “We are left with publications but no access to the underlying
data on reasonable request,” BMJ said.

    “This is worrying for trial participants, researchers, clinicians,
journal editors, policymakers, and the public. The journals that have
published these primary studies may argue that they faced an awkward
dilemma, caught between making the summary findings available quickly
and upholding the best ethical values that support timely access to
underlying data. In our view, there is no dilemma; the anonymized
individual participant data from clinical trials must be made
available for independent scrutiny.”

BMJ added that regulators are not there to “dance to the tune of rich
global corporations and enrich them further” but to protect the
general public’s health and for that reason, they said, we need
“complete data transparency for all studies, we need it in the public
interest, and we need it now.”

In December, the Centers for Disease Control and Prevention (CDC) was
also sued by the Informed Consent Action Network (ICAN) over claims
that it is improperly withholding COVID-19 vaccine safety data from
the American public.

ICAN is asking the CDC to provide de-identified post-licensure safety
data for the COVID-19 vaccines in the CDC’s v-safe system so as to
assure transparency with the general public regarding claims by both
the CDC and the Biden administration that COVID-19 vaccines are “safe
and effective.”

The British Medical Journal is one of the world’s oldest general
medical journals, having been founded in 1840, and has editorial
freedom from the British Medical Association.


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