Fact-checking of false allegations that Pfizer’s COVID-19 vaccine labels concealed safety information
Fact-checking of false allegations that Pfizer’s COVID-19 vaccine labels concealed safety information

Fact-checking of false allegations that Pfizer’s COVID-19 vaccine labels concealed safety information

Misinterpretations of COVID-19 vaccine adverse events have been one common source of misinformation during the whole pandemic. Now some social media users are heading into a list of unwanted incidents mentioned in one Pfizer vaccine safety report to create yet another false narrative.

“It is quite outrageous to think that the inputs to these vaccines were empty when they should have contained all these diseases and side effects,” he said. a video released on BitChute, a video hosting platform. “You really have to go through this yourself, but this is really today’s bomb news, by the week, by the year.”

A page-removed Instagram storage similarly scrolled through the 9-page list of adverse events at the end of Pfizer’s document. The post had the caption: “They knew it all along. CDC ACIP had these documents and STILL voted to give to children. These people are pure evil.”

The posts on social media also gave the impression that the unwanted incidents were eerily hidden from the public in a confidential report.

These posts were marked as part of Facebook’s efforts to combat fake news and misinformation on their news feed. (Read more about our collaboration with Facebook).

The adverse events listed in the Pfizer report are not necessarily caused by vaccines. And the vast majority of these incidents may not have happened to any vaccine recipients at all. The document is marked as confidential because it contained privileged commercial or financial information, not because it attempted to conceal security data.

What is an adverse event?

Adverse events are all health problems that occur after someone has received a drug, whether it is caused by the drug or not. That US Food and Drug Administration defines an adverse event as “any adverse and unintentional sign (such as an abnormal laboratory finding), symptom, or illness that is temporally associated with the use of a drug and does not involve any assessment of causality.”

Reports of adverse events are collected while a drug is undergoing clinical trials and after it has been released to the public. Documentation of adverse events is not limited to healthcare providers and researchers only – anyone can submit a report to the Vaccine Adverse Event Reporting System, the federal system for detecting side effects of vaccines. VAERS accepts all reports and does not require proof that an incident was caused by the vaccine – only that it occurred once after administration.

Not all adverse events that have been reported are included in a drug label because studies may show that they are not related to the drug. However, once an adverse event has been assessed as likely to be caused by the medicinal product, it is considered a side effect. These are added to the package leaflets for medicines along with other safety information and guidelines for proper use.

Pfizer’s document

That Pfizer document it is the source of these postings on social media is an analysis of reports of adverse events collected from December 2020 to the end of February 2021. During this period, the company’s COVID-19 was under emergency use permit.

Contrary to the claims of many social media posts, the literate list of adverse events at the end of the Pfizer report is neither a comprehensive catalog of conditions that have been reported as adverse events, nor a continuous log of illnesses and side effects caused. of vaccination.

The 9-page appendix in the Pfizer report shows adverse events of particular interest Pre-specified conditions that the FDA asks researchers and drug companies to monitor in relation to a drug. Inclusion on this list does not mean that the condition has actually been observed after vaccination.

The majority of the document before the annex, on the other hand, consists of adverse events that patients or others reported to have occurred after vaccination. Pfizer submitted this information to the FDA as part of its application for the full approval of the vaccine for persons aged 16 and over. These adverse events come from a variety of sources, including reports sent directly to the company, health authorities, medical research cases, and both non-interventional and clinical trials. All adverse reactions were included, whether or not related to the vaccine.

The Pfizer report also explicitly notes the limitations of reporting adverse events, stating that all reports are voluntarily submitted and inclusion does not necessarily indicate causality.

‘Confidential’ does not mean maliciously concealed

Pfizer’s document is dated April 2021, and the FDA recently released it in response to a request for Freedom of Information Act (FOIA) from Public health and medical professionals for transparency, a group that says its goal is to “obtain and disseminate the data that the FDA trusts to license COVID-19 vaccines.” Among its members are -one number of people WHO is known to have spread misinformation about COVID-19.

The group posted the documents on its website without any contextual information.

Pfizer’s document bears a “confidential” label and states that: “The information in this document is proprietary and confidential. Any disclosure, reproduction, distribution or other disclosure of this information outside of Pfizer, its affiliates, its licensees or regulatory rules. Agencies is strictly prohibited. “

But a “confidential” label does not necessarily mean that Pfizer or the FDA hid important safety information from the public. By law, the FDA has a ban on publicly announcing the existence of new drug applications until they are approved. Although this information may be made available upon request, parts that fall under one FOIA exemption for trade secrets and commercial or financial information that is privileged or confidential must be removed before publication, as in the case of this document.

Safety data for the Pfizer-BioNTech COVID-19 vaccine have been made public since 2020. The U.S. Centers for Disease Control and Prevention says the COVID-19 vaccines are safe and effective for both children and adults.

Our verdict

Posts on social media claim that the drug labels for the Pfizer COVID-19 vaccine “were empty when they should have contained all these diseases and adverse events” listed in a confidential report.

In an application submitted to the FDA, Pfizer included a pre-specified list of potential side effects of “special interest” that the FDA is asking researchers to keep an eye on. Social media postings mischaracterized this list.

The list of these adverse reactions in this document does not mean that they actually occurred in patients. The adverse events reported after receiving the company’s COVID-19 vaccine also do not necessarily mean that the vaccine caused them.

And the document is marked as confidential, not because the company tried to hide security information, but because it contained privileged commercial or financial information.

When a study establishes that a specific side effect was likely to be caused by a drug, it is considered a side effect. Adverse reactions are added to the Package Leaflet along with other safety information and guidelines for proper use.

Social media postings do not acknowledge these important reservations.

We rate the posts as fake.

RELATED: How an alternative gateway to VAERS data helps nurture vaccine misinformation

RELATED: The Federal VAERS database is a critical tool for researchers, but a breeding ground for misinformation

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