Emergency Preparedness and Vaccine Safety
CDC’s Immunization Safety Office (ISO) prepares for emergencies by ensuring that robust systems are in place to rapidly monitor vaccine safety in the event of an emergency vaccination program.
During an emergency involving mass vaccination, monitoring vaccine safety is important because:
- The vaccines being used might be new. With any new vaccine, initial safety data might be limited. In this situation it will be important to closely monitor safety to detect unexpected or concerning patterns.
- Large numbers of vaccines might be given in a short period of time, and therefore more adverse events (possible side effects) might be reported to the Vaccine Adverse Event Reporting System (VAERS).
- Public awareness of vaccination programs during an emergency might stimulate reporting to VAERS resulting in higher volume reporting than during non-emergency situations
- V-safe is a new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. V-safe uses text messaging and web surveys from CDC to check in with vaccine recipients following COVID-19 vaccination. V-safe also provides second vaccine dose reminders if needed, and telephone follow up to anyone who reports medically significant (important) adverse events
- VAERS accepts vaccine adverse event reports from patients, parents, healthcare professionals, vaccine manufacturers and others. CDC and FDA scientists review reports and use statistical techniques to detect unusual or unexpected patterns that might indicate a vaccine safety problem.
- The Clinical Immunization Safety Assessment (CISA) Project is a national network of vaccine safety experts which addresses vaccine safety issues, conducts clinical research and assesses complex clinical adverse events following vaccination.
- The Vaccine Safety Datalink (VSD) project gathers information on vaccines given to members of certain health care organizations around the country. A system called rapid cycle analysis allows CDC to address vaccine-associated health problems very quickly.
- Vaccine Safety Coordinators positioned in 62 health departments in states, territories, large urban areas and freely associated states carry out vaccine safety and emergency preparedness activities while coordinating with CDC.
In the COVID-19 response, protocols and standard operating procedures (SOPs) have been developed to help public health professionals perform tasks related to COVID-19 vaccine safety and monitoring. These SOPs also provide guidance to CDC staff when something may seem out of the ordinary or does not have a specific set of instructions. CDC has multiple vaccine safety monitoring systems in place to help keep COVID-19 vaccines safe. SOPs to monitor COVID-19 vaccines have been developed for each of the systems.
Learn more about Ensuring the Safety of COVID-19 Vaccines in the United States
These SOPs are living documents and subject to updates as needed.
CDC is investigating reports of people who developed myocarditis (inflammation of the heart muscle) after COVID-19 vaccination. Most of these people have recovered from their symptoms but information is needed on long-term effects of myocarditis. The purpose of this project is to understand long-term health effects of myocarditis. This is critically important to explaining the risks and benefits of COVID-19 vaccination to the public and informing clinical guidance.
V-safe is an active surveillance program to monitor the safety of COVID-19 vaccines during the period when the vaccines are authorized for use under Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and possibly early after vaccine licensure. The purpose of v-safe surveillance is to rapidly characterize the safety profile of COVID-19 vaccines when given outside a clinical trial setting and to detect and evaluate clinically important adverse events and safety issues that might impact policy or regulatory decisions.
V-safe protocol – version 5 [PDF – 87 Pages] updated April 18, 2022
V-safe Pregnancy Registry Protocol (amendment) version 2 [PDF – 11 Pages] updated March 18, 2021
This national surveillance systems collects and reviews adverse events following vaccination. Included with routine data collection, VAERS team members will review all adverse events following COVID-19 vaccination daily and will collect information on specific outcomes. Gathered information will be reported out to FDA and CDC.
VAERS Standard Operating Procedures for COVID-19 Feb. 2022 Update [PDF – 37 pages] updated Feb. 2, 2022
The VSD is a collaboration between CDC and nine integrated healthcare organizations across the United States that conducts active vaccine safety surveillance and research. This system is also used to help determine whether possible side effects identified using VAERS are actually related to vaccination.
VSD RCA Protocol Version 1.4 [PDF – 33 pages] updated Feb. 1, 2022
VSD Menstrual Irregularities Working Group (MI-WG) Protocol [PDF – 10 pages] updated Jan. 27, 2022
VSD Tree-Based Data Mining Protocol version 1.8 [PDF – 13 pages] updated Jan. 7, 2022
Mortality and Vaccination with COVID-19 Vaccines Study Protocol [PDF – 12 Pages] updated May 26, 2021
Development and Implementation of a Text- and Internet-Based monitoring System for Adverse Events Following COVID-19 Vaccination: A Pilot in Kaiser Permanente Southern California [PDF – 38 pages] updated April 13, 2021
VSD RCA Protocol Summary [PDF – 10 Pages] updated February 24, 2021
Long COVID-19: Changes in Healthcare Utilization Following Infection with SARS-CoV-2 [PDF – 11 pages] updated February 18, 2021
The CISA Project uses clinical experts located across the country to monitor and address vaccine-related safety concerns, including advising on special cases for healthcare providers and health departments. The project’s clinical consultation has an extension on-call service to address COVID-19 vaccine safety related inquiries, called CISA COVIDvax.
CISA COVIDvax Work Plan [PDF – 29 pages] updated Dec. 2, 2020
Investigating Long Term Effects of Myocarditis
- Myocarditis Outcomes after mRNA COVID-19 Vaccination Investigation version 1 [PDF – 5 pages] updated Oct. 7, 2021
- V-safe Protocol – version 4 [PDF – 69 Pages] updated March 10, 2022
- V-safe Protocol – version 3 [PDF – 55 pages] updated May 20, 2021
- V-safe Pregnancy Surveillance (amendment) [PDF – 11 Pages] updated Dec. 29, 2020
- V-safe Protocol – version 2 [PDF – 58 pages] updated Jan. 28, 2021
- Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 version 3 [PDF – 30 pages] updated Jan. 29, 2021
- Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 version 2 [PDF – 30 pages] updated Dec. 4. 2020
- Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 version 1 [PDF – 30 pages] updated Nov. 30, 2020
- VSD RCA Protocol version 1.3 [PDF – 33 pages] updated Nov. 12, 2021
- COVID-19 Vaccine Safety Evaluation in Pregnant Women and their Infants version 1.5 [PDF – 37 pages] updated June 29, 2021
- COVID-19 Vaccine Safety Evaluation in Pregnant Women and their Infants version 1.0 [PDF – 20 pages] updated June 17, 2021
- COVID-19 Vaccine safety, Spontaneous Abortion (SAB) and Stillbirth in the VSD Protocol version 1.5 [PDF – 28 Pages] updated Apr. 28, 2021
- COVID-19 Vaccine-Mediated Enhanced Disease (VMED) and Vaccine Effectiveness in the VSD Protocol version 1.2 [PDF – 18 pages] updated Apr. 27, 2021
- VSD Tree-Based Data Mining Protocol version 1.3 [PDF – 13 pages] updated Apr. 1, 2021
- VSD RCA Protocol version 1.1 [PDF – 31 Pages] updated March 3, 2021
In response to concern about smallpox possibly being used as a biological weapon, President George W. Bush launched the National Smallpox Pre-Event Vaccination Program on December 13, 2002. Studying the vaccine’s safety was an essential aspect of the program. A system for passive surveillance (a scientific term which means that you can choose if you report possible side effects) was built from VAERS.
For more information, read the special supplement of the journal Clinical Infectious Diseases, entitled “Posteradication Vaccination Against Smallpox.”
ISO played a major role in the H1N1 influenza pandemic of 2009 and 2010. CDC utilized VAERS and VSD to monitor the safety of the H1N1 influenza vaccine. In addition, the Department of Health and Human Services established the H1N1 Vaccine Safety Risk Assessment Working Group to review 2009 H1N1 vaccine safety data as it accumulated.
For more information, read The 2009 H1N1 Pandemic: Summary Highlights, April 2009-April 2010.