Page:V-safe Pregnancy Registry Protocol, Version 2.pdf/6

v-safe pregnancy registry protocol: March 18, 2021, version 2 record release, in order to verify diagnoses and complement information obtained over the phone. Medical record requests will be minimized to those required for development of clinical history and diagnosis verification.

Unreachable

The pregnancy call center might be unable to reach some pregnant persons exposed to COVID-19 vaccination for a variety of reasons. If there is a lack of response to a telephone call from the call center, the pregnant person receives a voicemail explaining the purpose of the call, in addition to a text message stating that the CDC pregnancy registry attempted to contact her. If the person does not respond to phone calls or text messages despite two separate attempts, performed 3 days apart at a different time of day, the pregnant person will be considered as unreachable and will no longer be included in the phone survey component of the registry. Any pregnant participant in the call center and registry may opt of out of the phone surveys or medical record release at any time. Opting out of the pregnancy phone surveys and/or medical record release does not preclude continued participation in v-safe.

Potential for duplication of data

Because the v-safe active surveillance program will also collect information on health impact events among participants that will result in a follow-up call and submission of a VAERS report, there is the potential for duplicative efforts among pregnant persons within v-safe and between the v-safe and VAERS pregnancy surveillance systems. V-safe and VAERS ISO staff will work closely together in order to minimize these duplicative efforts and to minimize the potential burden on pregnant persons and their healthcare providers. If a pregnancy is reported at the same time as a clinically important adverse event (defined by v-safe as a symptom or health condition that led to inability to work, led to inability to perform daily activities, or required care from a doctor or other healthcare professional), the event will first be reported to the VAERS call center per the v-safe protocol. After the pregnant person is contacted by the VAERS call center, she will then be contacted by the pregnancy call center team to inquire about her pregnancy and participation in the pregnancy registry. Additionally, if a pregnant person enrolls in v-safe and participates in the pregnancy registry and she or her healthcare provider independently submits a spontaneous VAERS report, the CDC v-safe pregnancy call center will only collect medical records that are not being collected via the standard VAERS procedures. This will be done to minimize the number of times a vaccine recipient is contacted, avoid duplicating efforts to obtain medical records, and avoid collecting overlapping information on the same vaccine recipients in multiple surveillance systems.

Clinical Review

Obstetric, neonatal and infant outcomes in the pregnancy registry will be reviewed by a panel of CDC clinical subject matter experts in order to accurately and consistently identify and classify potential pregnancy and infant clinical outcomes associated with exposure to COVID-19 vaccines. The review process will involve examination of all reported clinical data. Subject matter experts on the review panel may include obstetrician/gynecologists, pediatricians, pediatric infectious disease experts, vaccine safety experts, nurses, epidemiologists, analysts and others with extensive experience in birth defects surveillance. As needed, experts in specific areas not otherwise covered by the clinical review panel will be consulted (e.g. clinical geneticist, developmental specialist). Data will undergo review by multiple reviewers to ensure consistency in case classification, clinical review quality standards and ensure consensus in the interpretation of reported data and outcomes.