“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.”