At a glance
- The Clinical Immunization Safety Assessment (CISA) Project is a network of vaccine safety experts from CDC, research centers and other partners.
- CISA provides consultations for U.S. healthcare providers with complex vaccine safety questions about their patients.
- CISA conducts vaccine safety research and contributes to emergency response activities.
Overview
CDC's Clinical Immunization Safety Assessment (CISA) Project, established in 2001, is a national network of vaccine safety experts from CDC, eight medical research centers and other partners.
CISA's activities include
- Improving understanding of adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) at the individual patient level.
- Providing consultations for U.S. healthcare providers with complex vaccine safety questions about their patients.
- Conducting vaccine safety clinical research to investigate questions important to vaccine safety.
CISA goals
- Assist U.S. healthcare providers and health departments with immunization decision-making.
- Assist CDC and its partners with evaluating emerging vaccine safety issues.
- Conduct clinical research studies to better understand vaccine safety and to find preventive strategies for adverse events following immunization (e.g., drinking water after a vaccination to prevent feeling faint or lightheaded).
CISA activities
Clinical case reviews
- Providing free clinical case consultations to answer complex vaccine safety questions about U.S.-based patients.
- Offering clinical expertise in disciplines including infectious diseases, neurology, allergy, immunology, pediatrics, hematology, and obstetrics/gynecology.
Request a free clinical case consultation
U.S. healthcare providers and health departments can request free CISA clinical case consultations for complex vaccine safety questions not readily answered with ACIP guidelines about patients residing in the United States.
Expert evaluation of vaccine safety issues
- Sharing expert advice leading to broader understanding of vaccine safety issues.
- Identifying trends in vaccine safety that can be communicated broadly to medical providers.
- Contributing to clinical guidance including Advisory Committee on Immunization Practices (ACIP) recommendations related to vaccine safety.
Research
- Researching studies addressing vaccine safety questions including those for COVID-19 and influenza vaccines.
- Conducting scalable, prospective studies for U.S.-licensed vaccines to:
- Address clinical vaccine safety questions in populations often excluded from pre-licensure clinical trials, such as pregnant people.
- Complement vaccine safety surveillance systems.
- Address clinical vaccine safety questions in populations often excluded from pre-licensure clinical trials, such as pregnant people.
- Having capacity to:
- Study more common, non-medically attended events (e.g., fever).
- Collect post-vaccination biological specimens to look at the relationship between laboratory results (e.g., antibody levels) and study outcomes.
- Study more common, non-medically attended events (e.g., fever).
Public health response
- Using established procedures to assist healthcare and health departments in vaccine safety emergency response (such as the COVID-19 pandemic).
Clinical case consultations
Disclaimer
If your patient is experiencing a medical emergency, call 911 or your local emergency service provider.
Advice from CDC and CISA is meant to assist in decision-making rather than to provide direct patient management. Patient management decisions are the responsibility of the treating healthcare provider. CISA may require up to three months to collect and review all pertinent medical records, review the medical literature, review vaccine safety surveillance reports for similar reports of adverse events, and discuss the case on a clinical consultation call with CISA members and the patient's healthcare provider.
Advice from CDC and CISA is meant to assist in decision-making rather than to provide direct patient management. Patient management decisions are the responsibility of the treating healthcare provider. CISA may require up to three months to collect and review all pertinent medical records, review the medical literature, review vaccine safety surveillance reports for similar reports of adverse events, and discuss the case on a clinical consultation call with CISA members and the patient's healthcare provider.
Request a consultation
In case of emergency
For an emergency clinical 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 on-call staff.
Non-COVID-19 vaccine consultation
Healthcare providers or health department staff can send an email to CISA with:
- Your name and phone number.
- Your health professional training category (e.g., medical doctor, nurse practitioner, pharmacist).
- 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.
COVID-19 vaccine consultation
- Healthcare providers or health department staff can call 1-800-CDC-INFO (800-232-4636) OR submit a CDC-INFO webform request.
- Indicate that the request is for CISA Project consultation, and it will be sent to the CISA COVIDvax clinicians for review.
- Provide the following in the form:
- Your name and phone number.
- Your health professional training category (e.g., medical doctor, nurse practitioner, pharmacist).
- Your request for a CISA COVIDvax consultation.
- 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.
- Your name and phone number.
Consultation process
- Provider submits their free clinical consultation request.
- CDC or CISA staff will contact you if more information is required.
- CDC or CISA staff will contact you if more information is required.
- The CDC CISA Team reviews and sends select inquiries to the CISA project sites for in-depth evaluation.
- If not sent for evaluation, the CDC CISA Team addresses the question or defers to another channel for a response.
- If not sent for evaluation, the CDC CISA Team addresses the question or defers to another channel for a response.
- CISA notifies provider if they will review their case (within 1–2 weeks after submission of request).
- CISA meets to conduct clinical case evaluation. Often, the requesting healthcare provider attends and participates in the discussion.
- During each case's evaluation, an investigator presents:
- The clinical case, including the history of present illness (the adverse event following vaccination).
- Detailed physical examination and diagnostic (laboratory and other) findings.
- A summary of literature related to the condition and other vaccine safety data, such as from the Vaccine Adverse Event Reporting System (VAERS).
- Experts discuss the findings and form a general assessment and plan.
- The clinical case, including the history of present illness (the adverse event following vaccination).
- CISA shares conclusions with the healthcare provider.
Usually, CISA investigators and CDC have no direct contact with the patient.
Keep in mind
If you are not a healthcare provider or health department staff member and have a vaccine safety question: Ask your healthcare provider to send an inquiry on your behalf by following the steps above, OR Call 1-800-CDC-INFO (800-232-4636) or visit www.cdc.gov/cdc-info.
Resources
Clinical decision-making
- Algorithm to assess causality after individual adverse events following immunizations
- Algorithm for treatment of patients with hypersensitivity reactions after vaccines