The Official Response From the CDC About the Death Safety Signal Being Triggered in VAERS
The CDC blocks all my emails, so a doctor friend of mine sent in the question.
This question was submitted to the CDC on October 11, 2022 1:54 PM (Pacific Time):
Is this true that the death safety signal in VAERS triggered and nobody at the CDC noticed as pointed out in this article.
If not, can you supply the correct calculation?
The CDC’s response (6 weeks later)
As you might expect, they side-stepped the question.
They said that since the calculation was done by a third party, they couldn’t comment on it.
But you can rest assured that the CDC is monitoring VAERS for safety signals!
Here is the official response that was received
Dear Dr. <redacted>:
Thank you for your inquiry to Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, MD, MPH, regarding your concerns about the Vaccine Adverse Event Reporting System (VAERS). Your message was referred to my office for a response.
CDC was not involved with the work you mentioned in your correspondence, which used limited information from a publicly accessible VAERS database. Please see the disclaimer on the CDC WONDER site for more information: About the VAERS System. CDC is unable to comment on this analysis conducted outside of the agency. CDC has been publicly presenting and openly discussing data from our vaccine safety monitoring systems regarding coronavirus disease 2019 (COVID-19) vaccinations at meetings of the Advisory Committee on Immunization Practices (ACIP) and we have also regularly published analyses of these data. Statements that imply that reports of deaths to VAERS following vaccination equate to deaths caused by vaccination are scientifically inaccurate, misleading, and irresponsible. We continue to monitor these and other adverse events using our safety surveillance systems.
Authorized and approved COVID-19 vaccines are being administered under the most comprehensive and intensive vaccine safety monitoring effort in U.S. history. CDC expanded and strengthened its ability to monitor vaccine safety and created new ways to gather information about the safety of COVID-19 vaccines. Robust systems and processes are in place to identify and evaluate potential vaccine safety concerns. Monitoring vaccine safety involves multiple complementary ongoing systems. Within CDC, these systems include VAERS, the Vaccine Safety Datalink, the Clinical Immunization Safety Assessment Project, v-safe, and the v-safe Pregnancy Registry. For more information on vaccine safety monitoring systems at CDC, please see: Vaccine Information and Safety Studies | Vaccine Safety.
Anyone can submit reports to VAERS, including patients, family members, healthcare providers, and vaccine manufacturers, regardless of the plausibility of the vaccine causing the event or the clinical seriousness of the event. Data from VAERS are especially useful for the timely detection of unusual or unexpected patterns of adverse event reporting that might indicate a possible safety concern (or “safety signal”) about a vaccine. VAERS is not designed to assess causality; VAERS is designed to collect data, detect potential safety signals, and generate hypotheses.
Around 90% of reports to VAERS after COVID-19 vaccination have been non-serious. Healthcare providers who administer COVID-19 vaccines are required under the provider agreements for the CDC COVID-19 Vaccination Program and Emergency Use Authorizations (EUAs) by the Food and Drug Administration (FDA) to report certain serious adverse events, like deaths, to VAERS regardless of whether the reporter thinks the vaccine caused the adverse event. This required reporting is one reason why many reports to VAERS do not represent adverse events caused by the vaccine.
Physicians at CDC and FDA continuously screen and analyze VAERS data for possible safety concerns related to COVID-19 vaccines, including review of individual reports and aggregate data analysis. Reports of death after COVID-19 vaccination are rare. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it is unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. More than 624 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through October 6, 2022. During this time, VAERS received 16,803 preliminary reports of death among people who received a COVID-19 vaccine. As part of the vaccine safety review and analysis process, CDC and FDA clinicians obtain additional information for these reported patients, including death certificates, autopsy reports, and medical records.
Through these methods, FDA and CDC have successfully identified various rare safety signals related to COVID-19 vaccines, including anaphylaxis, thrombosis with thrombocytopenia (TTS) following use of the Johnson & Johnson/Janssen COVID-19 vaccine, and myocarditis and pericarditis following use of the Pfizer-BioNTech and Moderna COVID-19 vaccines. This information is included in the fact sheets for both healthcare providers administering vaccines and for vaccine recipients and caregivers. Continued monitoring has identified nine deaths causally associated with Johnson & Johnson/Janssen COVID-19 vaccination, who all died after developing TTS. On May 5, 2022, FDA revised the EUA for the Johnson & Johnson/Janssen COVID-19 vaccine to limit the authorized use of the vaccine to people ages 18 years and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to people ages 18 years and older who elect to receive the Johnson & Johnson/Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.
CDC continues to monitor the COVID-19 pandemic and is partnering with international, state, and local governments and public health partners to respond to this public health threat. For further information on the response and the current situation in the United States and abroad, please visit www.cdc.gov/COVID-19/.
We appreciate your interest in this important public health issue and hope you find this information helpful.
Michael McNeil, MD MPH
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Disease
Centers for Disease Control and Prevention (CDC)
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