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Fact-checking false claims that Pfizer’s COVID-19 vaccine labels hid safety information
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- The Pfizer report analyzes adverse events, which include any health issue that arises following vaccination regardless of whether it was caused by the vaccine.
- The appendix of adverse events in the report are pre-specified conditions that the FDA asks researchers and drug companies to monitor for, not a log of cases that have actually been observed post-vaccination.
- The U.S. Centers for Disease Control and Prevention says that the COVID-19 vaccines are safe and effective for both children and adults.
Misinterpretations of COVID-19 vaccine adverse events have been a common source of misinformation throughout the pandemic. Now, some social media users are homing in on a list of adverse events mentioned in a Pfizer vaccine safety report to create another false narrative.
"It's quite revolting to think that the inserts for these vaccines were blank when they should have contained all these diseases and adverse events," said one video posted on BitChute, a video-hosting platform. "You really have to go through this yourselves, but this is really the bombshell news of the day, of the week, of the year."
A since-removed Instagram post similarly scrolled through the nine-page list of adverse events at the end of Pfizer’s document. The post was captioned: "They knew all along. The CDC ACIP had these documents and STILL voted to give to children. These people are pure evil."
The social media posts also gave the impression that the adverse events were nefariously hidden from the public in a confidential report.
These posts were flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook).
The adverse events listed on the Pfizer report aren't necessarily caused by vaccines. And the vast majority of those events may not have happened to any vaccine recipients at all. The document is marked confidential because it contained privileged commercial or financial information, not because it was trying to hide safety data.
Adverse events are any and all health issues that arise after someone receives a drug, whether or not it's caused by the drug. The U.S. Food and Drug Administration defines an adverse event as "any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality."
Reports of adverse events are collected while a drug is undergoing clinical trials and after it has been released to the general public. Documentation of adverse events aren't restricted to just healthcare providers and researchers — anyone can submit a report to the Vaccine Adverse Event Reporting System, the federal vaccine adverse event tracking system. VAERS accepts all reports and does not require proof that an event was caused by the vaccine — only that it occurred sometime after administration.
Not all adverse events that have been reported are included in a drug label because investigation may show they are not related to the drug. When an adverse event has been evaluated to be likely caused by the drug, however, it is then considered an adverse reaction. These are added to drug package inserts along with other safety information and proper usage guidelines.
The Pfizer document that’s the source of these social media posts is an analysis of adverse event reports collected from December 2020 through the end of February 2021. During this period, the company’s COVID-19 was under emergency use authorization.
Contrary to the assertions of many social media posts, the alphabetized 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 running log of diseases and side effects caused by vaccination.
The nine-page appendix in the Pfizer report lists adverse events of special interest – pre-specified conditions the FDA asks researchers and drug companies to monitor for in relation to a drug. Inclusion in this list does not mean that the condition has actually been observed post-vaccination.
The bulk of the document that appears before the appendix, on the other hand, consists of adverse events that patients or others reported having occurred following vaccination. Pfizer submitted this information to the FDA as part of its application for the vaccine’s full approval for people age 16 and older. These adverse events come from a variety of sources, including reports directly sent to the company, health authorities, cases in medical research, and both non-interventional and clinical studies. All adverse events were included regardless of whether or not they were related to the vaccine.
The Pfizer report also explicitly notes the limitations of adverse event reporting, stating that all reports are voluntarily submitted, and inclusion does not necessarily signal causality.
Pfizer’s document is dated April 2021, and the FDA recently released it in response to a Freedom of Information Act (FOIA) request from Public Health and Medical Professionals for Transparency, a group that says its aim is to "obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines." Among its members are a number of people who are known to have spread misinformation around COVID-19.
The group posted the documents on its website, without any contextual information.
Pfizer’s document does have a "confidential" label and says that: "The information contained in this document is proprietary and confidential. Any disclosure, reproduction, distribution, or other dissemination of this information outside of Pfizer, its Affiliates, its Licensees, or Regulatory Agencies is strictly prohibited."
But a "confidential" label does not necessarily mean that Pfizer or the FDA were hiding crucial safety information from the public. By law, the FDA is prohibited from publicly disclosing the existence of new drug applications until they are approved. While this information can be made available by request, portions that fall under a Freedom of Information Act exemption for trade secrets and commercial or financial information that is privileged or confidential must be removed prior to release, as in the case of this document.
Safety data for the Pfizer-BioNTech COVID-19 vaccine have been publicly available since 2020. The U.S. Centers for Disease Control and Prevention says that the COVID-19 vaccines are safe and effective for both children and adults.
Social media posts claim that the drug labels for the Pfizer COVID-19 vaccine "were blank 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 "special interest" potential adverse events that the FDA asks researchers to look out for. The social media posts mischaracterized that list.
The listing of those adverse events in this document does not mean that they actually occured in patients. Nor do the adverse events reported after receiving the company’s COVID-19 vaccine necessarily mean that the vaccine caused them.
And the document is marked confidential not because the company was trying to conceal safety information, but because it contained privileged commercial or financial information.
When an investigation determines that a specific adverse event was likely caused by a drug, it is then considered an adverse reaction. Adverse reactions are added to drug package inserts along with other safety information and proper usage guidelines.
The social media posts fail to acknowledge these important caveats.
We rate the posts False.
RELATED: How an alternative gateway to VAERS data helps fuel vaccine misinformation
RELATED: Federal VAERS database is a critical tool for researchers, but a breeding ground for misinformation
PolitiFact, No truth that VAERS system shows 6,000 "died because of" COVID-19 vaccines, Aug. 9, 2021
PolitiFact, Deaths after vaccination don’t prove that COVID-19 vaccine is lethal, Feb. 16, 2021
PolitiFact, No, the COVID-19 vaccine is not the deadliest vaccine ever made, Dec. 10, 2021
PolitiFact, No, reports to the CDC’s vaccine early warning system are not ‘vaccine deaths’, Apr. 6, 2021
Pfizer, 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports, Accessed Mar. 19, 2022
Video post, Mar. 1, 2022
Instagram post, Mar. 16, 2022
Food and Drug Administration, Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies, December 2012
Centers for Disease Control and Prevention, Pfizer-BioNTech COVID-19 Vaccine Reactions & Adverse Events, Nov. 5, 2021
Food and Drug Administration, Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format, January 2006
Food and Drug Administration, FDA Approves First COVID-19 Vaccine, accessed Aug. 23, 2021
PolitiFact, Federal VAERS database is a critical tool for researchers, but a breeding ground for misinformation, May 3, 2021
VAERS, Guide to Interpreting VAERS Data, Accessed Mar. 19, 2022
World Health Organization, COVID-19 vaccines: safety surveillance manual - Monitoring and responding to adverse events of special interest, Dec. 22, 2020
PolitiFact, Children are at far higher risk of myocarditis from COVID-19 infection than from vaccines, Feb. 15, 2022
PolitiFact, Don’t fall for this video: Hydroxychloroquine is not a COVID-19 cure, Jul. 28, 2020
PolitiFact, No, getting the COVID-19 vaccine won’t weaken your immune system, Dec. 10, 2021
Le Parisien, COVID-19, vaccins et fake news : Bigard, Lalanne, Henrion-Caude... on démêle le vrai du faux, May 31, 2021
PolitiFact, No, vaccinated people don’t make up 60% of new COVID-19 cases, Apr. 29, 2021
Code of Federal Regulations, 21 CFR 601.51, Accessed Mar. 22, 2022
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Food and Drug Administration, Comirnaty and Pfizer-BioNTech COVID-19 Vaccine, Accessed Mar. 19, 2022
Centers for Disease Control and Prevention, Benefits of Getting a COVID-19, Updated Feb. 25, 2022
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