STORY AT-A-GLANCE Why Is the FDA Hiding the Pfizer Vaccine Data?
Weeks after the FDA gave full approval to the Pfizer-BioNTech vaccine under the name Comirnaty, the only documentation publicly available was found in press releases and journal articles
A nonprofit group filed a Freedom of Information Act request for the data used to license Comirnaty and subsequently had to file a lawsuit to release the documents the FDA has a statutory obligation to publish within 30 days of approving a drug
Peter Doshi and Matthew Herder note the review team was likely understaffed and was rushed to finalize the review in three weeks, a process that normally takes 10 months. The review did not address concerns that the trial was unblinded or the high number of side effects from the vaccine
The package inserts for medical professionals in the Moderna and J&J vaccines are intentionally left blank, sending people to a website where they can download the information
Despite the FDA’s claim that it is committed to transparency, especially for COVID-19 emergency use authorizations (EUAs),1 the agency first requested 55 years to release the data supporting the approval of Comirnaty after a Freedom of Information Act (FOIA) request was filed,2 and then asked for an extra 20 years to fully comply.3
Pfizer has been in the news for over a year as a leading contender in the development of the genetic therapy injection for COVID-19. Their unwillingness to release data to support the FDA's approval of their product should come as no surprise since the company has a long history of criminal activity.
During the Civil War, Pfizer flourished and expanded under the war’s demand for pain killers and antiseptics.4 Unfortunately, in the century and a half since, Pfizer has been a habitual offender in shady dealings, having been sued in multiple venues over unethical drug testing, illegal marketing practices,5 bribery in multiple countries,6 environmental violations — including illegal dumping of PCBs and other toxic waste7 — labor and worker safety violations and more.8,9
Now, in Pfizer’s latest debacle with the COVID-19 jabs, the FDA is complicit in the shroud of secrecy around the drug company’s genetic therapy clinical trials. The extraordinary length of time requested for the data release is tantamount to hiding.
Nonprofit Group of Medical Professionals Files Lawsuit
December 11, 2020, the FDA10 issued an emergency use authorization (EUA) for the first COVID-19 genetic therapy injection produced by Pfizer-BioNTech. Days later BMJ editor Peter Doshi, Ph.D., and pharmacology professor Matthew Herder penned an insightful examination of the FDA data analysis that led to the approval.11
Doshi is an associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy and Matthew Herder is the director of the Health Law Institute at the Schulich School of Law and associate professor of pharmacology at Dalhousie University in Canada.12
The article raised significant doubts about the speed of the approval process. By August 23, 2021, the FDA13 had granted full approval to the Pfizer-BioNTech vaccine under the name Comirnaty. Weeks later, the only publicly available data was limited to press releases and journal articles, which investigative journalist Maryanne Demasi, Ph.D., notes, is “subject to conflicts of interest and bias.”14
This lack of information triggered a group of over 80 medical researchers, public health officers, scientists and journalists to form an alliance with the sole mission of obtaining and disseminating “the data relied upon by the FDA to license COVID-19 vaccines.”15
The nonprofit group is called the Public Health and Medical Professionals for Transparency (PMHPT). They moved quickly to file a lawsuit September 16, 202116 in the United States District Court Northern District of Texas in which they allege the FDA denied the organization's request:
https://articles.mercola.com/sites/articles/archive/2022/01/11/fda-pfizer-vaccine-data-release.aspx?ui=5ae7467eae4a7ac0c9e1a13d55bc844d04487f29440a644d7ec0509f53002783&sd=20210319&cid_source=dnl&cid_medium=email&cid_content=art2HL&cid=20220111_HL2&mid=DM1088005&rid=1376478172
