Emerging Infections Program (EIP) Surveillance

The EIP is a population based network in California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee composed of state health departments and their collaborators in local health departments, public health and clinical laboratories, infection control professionals, healthcare providers, and academic institutions dedicated to conducting surveillance for emerging infectious diseases of public health importance.

This special initiative is being performed through the state public health departments participating in the EIP for enhanced surveillance of GBS following 2009 H1N1 flu vaccination.

• Why is CDC conducting enhanced GBS surveillance for this vaccination campaign?
• What is the purpose of this 'EIP' reporting system?
• Who will be reporting to the EIP system?
• For how many months will GBS cases be reported to the EIP reporting system?
• Is this EIP reporting different from the mandated reporting I'm hearing about from the state?
• Why isn't reporting through the Vaccine Adverse Event Reporting System (VAERS) sufficient?
• What will I be expected to do as a participant in this system?
• Isn't information on these patients protected health information and restricted from sharing?
• What will be done with the information I provide?
• Is this activity considered research? Has there been Institutional Review Board (IRB) of this initiative?

Why is CDC conducting enhanced GBS surveillance for this vaccination campaign?

Scientists first reported a suspected link between GBS and vaccinations in 1976, during a national campaign to vaccinate people against a swine flu virus. The investigation found that vaccine recipients had a higher risk for GBS than those who were not vaccinated (about 1 additional case occurred per 100,000 people vaccinated). Given this association, and the fact that the swine flu disease was limited, the vaccination program was stopped. Scientists have multiple theories on why this increased risk may have occurred, but the exact reason for this association remains unknown.

The global emergence of the pandemic (H1N1) 2009 virus has prompted rapid development of new influenza A (H1N1) 2009 monovalent vaccine that will be available for immunizations starting in October 2009. It is expected that the 2009 H1N1 vaccine will have a similar safety profile as seasonal flu vaccines, which have very good safety track records. The association of GBS with the 1976 influenza H1N1 vaccines has led public health authorities to monitor for any similar association of neurologic disease with vaccines against the pandemic (H1N1) 2009 virus. However, it should be noted that as there will still be cases of GBS due to other causes occurring during this time, cases of GBS who received vaccine may not have GBS due to their immunization

Top of page

What is the purpose of this ’EIP’ reporting system?

The EIP initiative will provide a rapid and accurate assessment of any increased risk for GBS among people who receive the influenza A (H1N1) 2009 monovalent vaccine. Because all EIP sites will coordinate similar efforts at detecting and reporting all cases of GBS, CDC will be able to observe if there is an increase in the number of reported cases above the “expected” number of cases. This information will complement additional vaccine safety assessments from separate initiatives. If any problems are detected with this 2009 H1N1 vaccine, they will be reported to health officials, healthcare providers, and the public, and health officials will take needed action to ensure the public's health and safety.

This special initiative is being performed through the state public health departments participating in the CDC Emerging Infections Program (EIP). The EIP is a population-based network in California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee composed of state health departments and their collaborators in local health departments, public health and clinical laboratories, infection control professionals, healthcare providers, and academic institutions dedicated to conducting surveillance for emerging infectious diseases of public health importance.

Although the safety and efficacy of the influenza A (H1N1) 2009 monovalent vaccine will be assessed through a small number of limited clinical trials, the interval between vaccine development and widespread use of the vaccine will be compressed and timely surveillance for GBS will be critical in vaccine safety monitoring to assess public health policy and direct further 2009 H1N1 vaccine recommendations for the influenza season.

Top of page

Who will be reporting to the EIP reporting system?

Neurologists and other providers of neurology services who treat patients within the counties, and in some instances, the entire state affiliated with the EIP site will be asked to participate in this initiative.

Top of page

For how many months will GBS cases be reported to the EIP reporting system?

This special initiative will be initiated at the start of the 2009 H1N1 vaccination campaign in October 2009, and will last until May 2010.

Top of page

Is this EIP reporting different from the mandated reporting I’m hearing about from the state?

Ensuring the safety of vaccines is a high priority for CDC. CDC and its partners have an aggressive plan to actively monitor the 2009 H1N1 vaccine to ensure its safety, including the Vaccine Adverse Event Reporting System (VAERS), as well as this special initiative through the EIP sites.

Additionally, some states are going a step further and making GBS a physician-reportable condition within the state. This means that any physician who diagnoses a GBS case is asked to report the patient to local or state public health authorities. Reporting requirements will differ by state. This adds an additional level of certainty to ensure that an increase in GBS cases would not be missed. Also, in states where the EIP reporting initiative does not cover the entire state, this enables the state to monitor areas outside of the EIP jurisdictions for cases of GBS.

Top of page

Why isn’t reporting through VAERS (the Vaccine Adverse Event Reporting System) sufficient?

Reporting through VAERS is an important mechanism in assessing vaccine safety after licensure; however, due to the rapid development and implementation of the 2009 H1N1 vaccine, a more timely system is needed to report any problems with the vaccine. The EIP initiative will provide the most timely, accurate assessment of risk associated with the vaccine.

Top of page

What will I be expected to do as a participant in this system?

There are only a few, time-limited tasks that are being requested from neurologists participating in this reporting system:

1. Surveillance officers at each EIP site will be contacting a designated point of contact (POC) in your practice regularly by phone or email to ascertain if any new cases of GBS have been diagnosed in your practice. This POC can be the practice manager, a nurse manager, or yourself.
2. Surveillance officers may contact the diagnosing physician directly to answer brief questions (<5 minutes) regarding the patient’s case in situations when the patient’s medical record is not sufficient to document GBS.
3. All neurologists are urged to report cases of GBS suspected to be associated with H1N1 or any other vaccines to VAERS, the Vaccine Adverse Event Reporting System, as usual.(http://vaers.hhs.gov/)

Top of page

Isn’t information on these patients protected health information and restricted from sharing?

The HIPAA Privacy Rule expressly permits disclosures of protected health information without individual authorization to public health authorities authorized by law to collect or receive the information for the purpose of preventing or controlling disease, injury, or disability, including but not limited to public health surveillance, investigation, and intervention. This EIP initiative is specifically aimed at preventing and controlling injury or disability related to the influenza A (H1N1) 2009 monovalent vaccine, therefore the HIPAA Privacy Rule permits reporting of patient-specific information to the EIP sites. More information can be found at http://www.cdc.gov/privacyrule.

Top of page

What will be done with the information I provide?

All protected health information will be kept confidential. Patients will not be contacted for any other reason than for the purposes of this surveillance system. Information you provide will be used to identify a patient’s medical record for data review, and also to contact the patient to perform a brief telephone interview to identify GBS-related factors and vaccination history.

Top of page

Is this activity considered research? Has there been IRB (Institutional Review Board) review of this initiative?

This activity is not considered research, and IRB review is not required. The Associate Director for Epidemiologic Science of the National Center for Preparedness, Detection, and Control of Infectious Diseases at CDC has determined that this activity does not meet the definition of research. The purpose of this activity is to monitor the occurrence of GBS during the national influenza A (H1N1) vaccination campaign in the U.S. so that appropriate public health actions may be taken in a timely manner, should an unusual increase in GBS be detected. The Department of Health and Human Services defines research as “a systematic investigation…designed to develop or contribute to generalizable knowledge,” [45 CFR 46.102(d)]. This activity does not meet the definition of research, as it is not designed to develop or contribute to generalizable knowledge.

Top of page