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Vax Fact of the Week

Are COVID-19 Vaccines Continually Watched for Safety?

After clinical trials, FDA authorization or approval, and a recommendation on use from the CDC’s Advisory Committee on Immunization practices, all vaccines, including COVID-19 vaccines are monitored for both safety and efficacy. You may have heard of a system called VAERS, but that is only one part of the monitoring ecosystem. In addition to two other monitoring systems used for all vaccines, the U.S. government has added vaccine safety monitoring systems specifically for COVID-19 vaccines.

The usual safety monitoring systems in place for all vaccines include:

  • Vaccine Adverse Events Reporting System (VAERS) – Anyone can report a side effect after a vaccine to VAERS, which means not everything reported to VAERS is actually a side effect caused by vaccines. Federal officials monitor this system closely to identify unexpected side effects or side effects that occur more often than expected. A study into the cause of those side effects is immediately launched.
  • Vaccine Safety Datalink (VSD) – VSD is a network of nine large healthcare systems that proactively conducts vaccine surveillance and research. They monitor the anonymous data of everyone in their systems who have received a vaccine to see if there is any connection between a vaccine and a side effect. VSD is also used to figure out if side effects identified using VAERS are actually related to vaccination.
  • Clinical Immunization Safety Assessment (CISA) Project  CISA is a collaboration between CDC and seven medical research centers to provide expert consultation to doctors whose patients have experienced a rare side effect following vaccination. CISA also conducts clinical research studies about vaccine safety.

Beyond these three, core systems the U.S. government has developed and/or expanded additional programs to give the CDC, FDA, and others the ability to evaluate COVID-19 vaccine safety in real-time. These are:

  • V-SAFE isa new smartphone-based health checker for people who receive COVID-19 vaccines. V-SAFE uses text messaging and web surveys 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 adverse events.
  • National Healthcare Safety Network (NHSN) is an acute care and long-term care facility monitoring system that reports side effects from their patients directly to VAERS.
  • FDA’s Biologics Effectiveness and Safety (BEST) System and FDA’s Sentinel Initiative contain administrative and claims-based data to identify any side effects that are not reported to VAERS.
  • Centers for Medicare and Medicaid Services (CMS) Database collaborates with FDA to monitor the CMS database (including approximately 650,000 nursing home residents). Similar to the BEST and Sentinel Initiative, it will help identify side effects proactively.
  • Genesis is an expected new monitoring system. The National Institute on Aging awarded a grant to a team of researchers based at Brown University to design a monitoring system to identify and track adverse health impacts after nursing home residents receive COVID-19 vaccinations.
  • Veterans also have two additional monitoring systems. The Department of Veteran Affairs’ (VA) Data Warehouse and Electronic Health Records will actively surveil anonymous data for side effects after COVID-19 vaccination. The VA Adverse Drug Event Reporting Systems (VA ADERS) is a national reporting system similar to VAERS, but made specifically for veterans for all drugs and immunizations.
  • Active Military have their own resources as well. The Department of Defense (DOD) has their own DOD VAERS data, a Vaccine Adverse Event Clinical System (VAECS), and an Electronic Health Record and Defense Medical Surveillance System.
  • Finally, Tribal Nations have their own Indian Health Service (IHS) VAERS data which is served by both IHS and the Nations’ facilities.

If any serious safety issues are detected, immediate action will be taken to find out if the issue is related to the COVID-19 vaccine and determine the best course of action.

Thus far, the only serious signal detected so far is rare cases of blood clots and low platelets in patients who received the Johnson & Johnson (Janssen) COVID-19 vaccines. For more information on that rare condition, and for updates on whether anyone has died following the COVID-19 vaccine, please read this blog from our partners at Vaccinate Your Family.

Article source and credit: Vaccinate Your Family