Messages misinterpret Pfizer’s COVID-19 vaccine safety monitoring document

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The Pfizer logo on the exterior of a building in Belgium. Photo by Dieter Dewulf/DeFodi Images via Getty Images.

The first few pages of the document also explicitly address many of the limitations of adverse event reporting to help interpret the data correctly — limitations those who publish alarming articles on the document seem to have ignored it.

Pfizer’s analysis notes that the company’s safety database contains cases of adverse events “regardless of causality assessment” and indicates that many factors can influence reporting of an adverse event, and that the “Spontaneous reporting system should be used for signal detection.

“An accumulation of adverse event reports (AERs) does not necessarily indicate that a particular AR was caused by the drug; rather, the event may be due to an underlying disease or other factors such than medical history or concomitant medications,” he continues.

Far from proving that the Pfizer/BioNTech vaccine is unsafe, the Pfizer document is proof of the vaccine’s continued safety, Beninger said.

He also said Woodcock was absolutely correct that millions of doses of COVID-19 vaccine had been administered safely. “Absolutely yes, definitely, definitely,” he said.

Of Campbell, Beninger said, “His comments are very superficial and much of it is quite naive. The fact that all these reports were there proves nothing, everything has to be assessed. »

In the video, Campbell himself admits to having trouble reading the document.

Erroneous interpretation of the appendix

Many posts are also wrong in their interpretation of the appendix of the Pfizer document, which is an alphabetical list of 1,291 adverse events of particular interest. In his article, Wheeler even calls the appendix a “relevant part” and Campbell argues that the public should have known about the terms so people could “keep an eye on them”.

But the schedule, Beninger said, was really just a list of things Pfizer was monitoring — not a list of health issues that were observed post-vaccination or shown to be due to. the vaccination.

A clue comes from its formatting, he said. “When the events have actually happened, there is a breakdown,” he said. “They are not presented in a massive alphabetical list from A to Z.”

FDA FOIA

Some of the misleading claims online also relate to how the Pfizer document was obtained and suggest that there was a cover-up by the government, so we will provide some information on the subject.

As we have already established, there is no evidence that there was an identified safety issue, and therefore there is no evidence that regulators failed to share important safety information. with the audience.

The document was released by the FDA in response to a Freedom of Information Act request for Public Health and Health Professionals for Transparency. The group asked the FDA for all of its documents related to the Pfizer/BioNTech COVID-19 vaccine – or about 329,000 pages, plus other files — four days after the agency gave full approval to the vaccine.

The FDA did not object to the release of the information, but denied the group’s request for expedited processing, leading PHMPT to sue the agency in federal court in September, as MedPage Today did. Explain.

The FDA argued that the group’s request would require publishing 80,000 pages per month, which the agency said had never happened before with a FOIA request, and was difficult, if not impossible, with its current staff, who would have to wade through documents line by line and redact exempt material. The FDA offered to publish 500 pages per month instead, which it said was the standard rate.

PHMPT, on the other hand, vs that this proposed rate would take almost 55 years – and it was “hard to imagine a greater need for transparency” than making vaccine documents available.

On Jan. 6, a North Texas judge acknowledged the “unduly burdensome challenges” of the FOIA, but sided with the applicant, concluding that the application was of “overriding public importance”. He set the deadline for the first tranche of documents for January 31, with an additional 55,000 pages to be released each month. At this rate, all information will be released by the end of the summer.

PHPPT then posted the documents on its website. Soon after, misleading or false claims began circulating online about the safety of the Pfizer/BioNTech vaccine using the documents, which our colleagues at Health Feedback have also address.

As MedPage Today has it Explainthe FDA has already published summaries of the data it reviewed, and the FOIA documents “may not be important to an overall analysis of vaccine safety and efficacy.” Zach Zalewski, regulatory strategy consultant at Avalere Health, told the outlet, “There’s a risk of picking cherries and taking things out of context.”

Beninger, however, said the FDA had been “a bit deaf to what was going on around them,” and said he thought the agency should have been more careful. “I just think you practically have to bend over backwards to be transparent,” he said.

It should be noted that while Campbell calls the people who joined PHMPT “prestigious” and “highly qualified,” the list is primarily notable for its inclusion of several people who have made questionable claims about COVID-19 or vaccines. Among several others, the list of signatories includes Idaho pathologist Dr. Ryan Cole, who baselessly claimed that vaccines cause cancer, and Dr. Stella Immanuel, who falsely promoted hydroxychloroquine as a “cure.” COVID-19 and has previously claimed that some drugs are made from extraterrestrial DNA.

Editor’s Note: The SciCheck COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over the editorial decisions of FactCheck.org, and the opinions expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while reducing the impact of misinformation.

Sources

Manufacturer Administered COVID-19 Vaccine Doses.” Our world in data. Accessed March 18, 2022.

COVID-19 vaccinations in the United States.” COVID data tracker. CDC. Accessed March 18, 2022.

Selected Adverse Events Reported Following COVID-19 Vaccination.” CDC. Accessed March 18, 2022.

FDA takes key action in fight against COVID-19 by issuing emergency use authorization for first COVID-19 vaccine.” Press release. FDA. December 11, 2020.

FDA approves first COVID-19 vaccine.” Press release. FDA. August 23, 2021.

CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENTS

REPORTS OF PF-07302048 (BNT162B2) RECEIVED UNTIL FEBRUARY 28, 2021.” Pfizer. Consulted with public health and healthcare professionals for transparency website.

Jaramillo, Catalina. “Evidence is still lacking to support ivermectin as a treatment for COVID-19.” FactCheck.org. March 14, 2022.

Benigner, Paul. Associate Professor of Public Health and Community Medicine, Tufts University School of Medicine. Phone interview with FactCheck.org. March 16, 2022.

Understanding adverse events and side effects.” CDC. Accessed March 18, 2022.

Public Health and Health Professionals for Transparency website. Accessed March 18, 2022.

D’Ambrosio, Amanda. “FDA begins publishing Pfizer COVID Vax documents.” MedPage Today. March 7, 2022.

Pfizer’s confidential document shows adverse events reported after vaccination; it does not demonstrate that the vaccine caused the events or is dangerous.” Health reviews. March 11, 2022.

COVID-19 vaccine Comirnaty and Pfizer-BioNTech.” FDA. Accessed March 18, 2022.

FDA spokesperson. Email sent to FactCheck.org. March 16, 2022.

Spencer, Saranac Hale. “Idaho doctor makes baseless claims about COVID-19 vaccine safety.” FactCheck.org. April 19, 2021.

Spencer, Saranac Hale and Angelo Fichera. “In viral video, doctor misrepresents hydroxychloroquine as ‘cure’ for COVID-19.” FactCheck.org. July 28, 2020.

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