Safety (Pharmacovigilance) of COVID-19 Vaccines

Safety has been at the center of a heated debate during the mass experimental campaign employing the COVID-19 vaccines.

See also,

Resources

  • Jan 19, 2022 - 1000 Peer Reviewed Studies Questioning Covid-19 Vaccine Safety1)

Biological Plausibility for COVID-19 Vaccines to Cause COVID-19

Whether or not due to the spike protein or other factors that a COVID-19 vaccine can cause the COVID-19 condition is up for debate. Even weeks after mass vaccination programs began, researches had not yet determined whether or not vaccination could result in cytokine storming.2)

Aside from spike protein, the lipid nanoparticles in many of the vaccines

Safety Monitoring Systems

After a vaccine is authorized or approved for use, many vaccine safety monitoring systems watch for adverse events (possible side effects). This continued monitoring can pick up on adverse events that may not have been seen in clinical trials. If an unexpected adverse event is seen, experts quickly study it further to assess whether it is a true safety concern. Experts then decide whether changes are needed in U.S. vaccine recommendations. This monitoring is critical to help ensure that the benefits continue to outweigh the risks for people who receive vaccines.

VaST

The Vaccine Safety Technical (VaST) Work Group reports on vaccine safety from a variety of sources.

VaST Work Group Reports at the CDC (here).

Objectives of VaST

From the February 4, 2022 VaST Report:3)

  • Review, evaluate, and interpret post-authorization/approval COVID-19 vaccination safety data
  • Serve as the central hub for technical subject matter expertise from federal agencies conducting post-authorization/approval safety monitoring
  • Advise on analyses, interpretation, and presentation of vaccine safety data
  • Provide updates to the ACIP COVID-19 Vaccines Work Group and the entire ACIP on COVID-19 vaccine safety

Also from that report: “U.S. safety monitoring systems including Vaccine Adverse Events Reporting System (VAERS), Vaccine Safety Datalink (VSD), FDA BEST System,1 Department of Veterans Affairs (VA), Indian Health Service (IHS), Department of Defense (DoD)”

Other

FDA’s June 2020 guidance document also includes important recommendations for ongoing safety evaluation after any COVID-19 vaccine is made available in the United States.

CDC is working to expand safety surveillance through new systems and additional information sources, as well as by scaling up existing safety monitoring systems. Expanded Safety Monitoring Systems

The following systems and information sources add an additional layer of safety monitoring, giving CDC and FDA the ability to evaluate COVID-19 vaccine safety in real time and make sure COVID-19 vaccines are as safe as possible

CDC V-SAFE — A new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. V-SAFE will use text messaging and web surveys from CDC to check in with vaccine recipients for health problems following COVID-19 vaccination. The system also will provide telephone follow up to anyone who reports medically significant (important) adverse events.

CDC National Healthcare Safety Network NHSN — An acute care and long-term care facility monitoring system with reporting to the Vaccine Adverse Event Reporting System or VAERS

FDA Other large insurer/payer databases — A system of administrative and claims-based data for surveillance and research

Existing Safety Monitoring Systems

As people get vaccinated, CDC, FDA, and other federal partners use the following existing systems and data sources to conduct ongoing safety monitoring.

Vaccine Adverse Event Reporting System (VAERS)

The national system that collects reports from healthcare professionals, vaccine manufacturers, and the public of adverse events that happen after vaccination; reports of adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns are followed up with specific studies.

CDC Vaccine Safety Datalink VSD — A network of 9 integrated healthcare organizations across the United States that conducts active surveillance and research; the system is also used to help determine whether possible side effects identified using VAERS are actually related to vaccination.

  • COVID-19 Vaccination and Non–COVID-19 Mortality Risk — Seven Integrated Health Care Organizations, United States, December 14, 2020–July 31, 20214)

Other

CDC Clinical Immunization Safety Assessment CISA — A collaboration between CDC and 7 medical research centers to provide expert consultation on individual cases and conduct clinical research studies about vaccine safety

FDA and the Centers for Medicare and Medicaid Services: — A claims-based system for active surveillance and research

FDA Biologics Effectiveness and Safety System BEST — A system of electronic health record, administrative, and claims-based data for active surveillance and research

FDA Sentinel Initiative external icon — A system of electronic health record, administrative, and claims-based data for active surveillance and research

Members of the military

Department of Defense (DOD): DOD VAERS — Adverse event reporting to VAERS for the DOD populations

DOD *Vaccine Adverse Event Clinical System* VAECS — A system for case tracking and evaluation of adverse events following immunization in DOD and DOD-affiliated populations

DOD *DOD Electronic Health Record and Defense Medical Surveillance System* — A system of electronic health record and administrative data for active surveillance and research

Veterans

Department of Veterans Affairs (VA): VA Adverse Drug Event Reporting System VA ADERS external icon — A national reporting system for adverse events following receipt of drugs and immunizations

VA Electronic Health Record and Active Surveillance System — A system of electronic health record and administrative data for active surveillance and research

Tribal nations

Indian Health Service IHS IHS VAERS data external icon — Spontaneous adverse event reporting to VAERS for populations served by IHS and Tribal facilities

https://web.archive.org/web/20201019021700/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html

Indications of COVID-19 Vaccine-Associated Mortality

Pathologists and Medical Specialists

Dr. Sucharit Bhakdi and Dr. Arne Burkhardt summarized histopathologic analyses on 15 persons who died after vaccination and found 14 of those deaths to be associated with vaccination despite none of the coroners recording the appropriate associations.5)

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