Research, Monitoring and Outcomes Definitions for Vaccine Safety (ALN 93.344)

Research, Monitoring and Outcomes Definitions for Vaccine Safety (ALN 93. 344) is sponsored by Centers for Disease Control and Prevention (CDC). This CFDA/ALN number refers to cooperative agreements for vaccine safety research.

While not directly focused on exemptions, research into vaccine safety can influence public confidence and indirectly impact exemption rates.

About the Clinical Immunization Safety Assessment (CISA) Project | Vaccine Safety Systems | CDC Skip directly to site content About the Clinical Immunization Safety Assessment (CISA) Project 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 individual patients residing in the United States. CISA conducts vaccine safety research and contributes to emergency response activities. 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.

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 about individual patients residing in the United States that are not readily answered with CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines or Advisory Committee on Immunization Practices (ACIP) guidelines.

CISA's activities include Improving understanding of adverse events (any side effect or health problem after vaccination that is concerning, even if it is not clear if the vaccine caused it) at the individual patient level.

Providing consultations for U.S. healthcare providers with complex vaccine safety questions about individual patients that are not readily addressed by CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines or Advisory Committee on Immunization Practices (ACIP) guidelines. Conducting vaccine safety clinical research to investigate questions important to vaccine safety.

Assist U.S. healthcare providers and health departments with immunization decision-making for individual patients residing in the United States. 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., how to prevent feeling faint or lightheaded after vaccination).

Providing free clinical case consultations to U.S. healthcare providers to answer complex vaccine safety questions about individual patients residing in the United States. Offering clinical expertise in disciplines including infectious diseases, neurology, allergy, immunology, pediatrics, hematology, and obstetrics/gynecology.

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 ACIP recommendations related to vaccine safety.

Conducting research 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 women. Complement vaccine safety surveillance systems .

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. Using established procedures to assist healthcare and health departments in vaccine safety emergency response (such as the COVID-19 pandemic).

Clinical case consultations If your patient is experiencing a medical emergency, call 911 or your local emergency service provider. 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 U.S. healthcare providers or health departments with complex vaccine safety questions about individual patients residing in the United States that are not readily addressed by CDC's ACIP guidelines 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 U.S. healthcare providers or health departments with complex vaccine safety questions about individual patients residing in the United States that are not readily addressed by CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines can request a CISA COVIDVax consultation by: Calling 1-800-CDC-INFO (800-232-4636) OR submitting a CDC-INFO webform request.

Indicating that the request is for CISA Project consultation; it will be sent to the CISA COVIDvax clinicians for review. Providing 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.

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. Provider submits their free clinical consultation request. 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. 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.

CISA shares conclusions with the healthcare provider. Usually, CISA investigators and CDC have no direct contact with the patient. 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. Algorithm to assess causality after individual adverse events following immunizations Algorithm for treatment of patients with hypersensitivity reactions after vaccines Clinical Research Studies and publications Vaccine Safety Information for Healthcare Providers National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) CDC monitors the safety of vaccines through four complementary systems.

Vaccine Safety Monitoring Vaccine Safety Systems Resources