Clinical Immunization Safety Assessment (CISA) Project
Vaccine Safety Monitoring - CISA
CDC’s Clinical Immunization Safety Assessment (CISA) Project was established in 2001 to address the unmet vaccine safety clinical research needs of the United States.
CISA is a national network of vaccine safety experts from the CDC’s Immunization Safety Office (ISO), seven medical research centers, and other partners, which provides a comprehensive vaccine safety public health service to the nation.
Healthcare providers or health departments in the United States can request a consultation from CISA COVIDvax for a complex COVID-19 vaccine safety question that is (1) about an individual patient residing in the United States or vaccine safety issue and (2) not readily addressed by CDC or Advisory Committee on Immunization Practices (ACIP) guidelines.
This request can be made through CDC-INFO by:
- Calling 800-CDC-INFO (800-232-4636), or
- Submitting a request via CDC-INFO webform
When making the request, indicate that the request is for CISA Project consultation and it will be forwarded to the CISA COVIDvax clinicians for review.
Provide the following in the form:
- Your name and phone number
- Your health professional training category (i.e., medical doctor, nurse practitioner, pharmacist)
- Indication that a CISA COVIDvax consultation is requested
- Enough clinical background information to enable CDC CISA clinical staff to evaluate the inquiry properly.
Do not include patient names or personal identifying health information in the request.
In case of an emergent clinical COVID-19 vaccine safety inquiry, healthcare providers and health department staff can call the CDC Emergency Operations Center (EOC) Watch Desk at (770)-488-7100. The EOC Watch Desk will route emergency inquiries to the CISA COVIDvax on-call staff.
- Boston Medical Centerexternal icon Boston, MA
- Cincinnati Children’s Hospital Medical Centerexternal icon Cincinnati, OH
- Columbia Universityexternal icon New York, NY
- Duke Universityexternal icon Durham, NC
- Johns Hopkins Universityexternal icon Baltimore, MD
- Kaiser Permanente Northern Californiaexternal icon Oakland, CA
- Vanderbilt University Medical Centerexternal icon Nashville, TN
CISA addresses vaccine safety issues, conducts high quality clinical research, and assesses complex clinical adverse events following vaccination. CISA facilitates CDC’s collaboration with vaccine safety experts at leading academic medical centers and strengthens national capacity for vaccine safety monitoring. The CISA Project provides consultation to US clinicians who have vaccine safety questions about a specific patient residing in the US. In addition, CISA provides consultation to US healthcare providers and public health partners on vaccine safety issues, and reviews clinical adverse events following immunization ( AEFI) involving the US-licensed vaccines.
- To improve understanding of AEFI at the individual-patient level
- To serve as a vaccine safety resource for consultation on clinical vaccine safety issues, including individual case reviews, and to assist with immunization decision-making
- To assist the Centers for Disease Control and Prevention (CDC) / Health and Human Services (HHS) and partners in developing strategies to assess individuals who may be at increased risk for AEFI
- To conduct studies to identify risk factors and preventive strategies for AEFI, particularly in special populations
Clinical Case Reviews: CISA provides a clinical case evaluation service for US healthcare providers who have vaccine safety questions about a specific patient residing in the US. CISA provides clinical expertise in various disciplines, including neurology, allergy, immunology, pediatrics, hematology, and obstetrics/gynecology.
Expert Evaluation of Vaccine Safety Issues: CISA experts provide advice that has led to a broader understanding of vaccine safety issues and informs clinical or public health practices. CISA has also reviewed technical issues and contributed to Advisory Committee on Immunization Practices (ACIP) recommendations.
Research: To advance knowledge of vaccine safety and inform clinical and public health practice clinical research is essential. CISA has published and continues to develop research studies that address vaccine safety priorities, such as those identified in the US National Vaccine Planexternal icon.
Current priority areas for CISA research studies include influenza vaccine safety, vaccine safety in persons with autoimmune diseases, and vaccine safety in pregnant women. CISA complements other vaccine safety systems and focuses its efforts on scalable, prospective studies for US-licensed vaccines. These studies are designed to address clinical vaccine safety questions in targeted or special populations that are often excluded from pre-licensure clinical trials. CISA is well suited to study more common, non-medically attended events (e.g., fever) and to collect biological specimens after vaccination. CISA investigators also have access to special populations (e.g., persons with autoimmune diseases) and specialists who care for these patients.
Public Health Response: CISA has procedures in place to assist in response to vaccine safety emergencies, such as a pandemic, and to assist state health departments during an emergency.