Portal:Centers for Disease Control and Prevention

“ Safety data from infants exposed during pregnancy is not available because of the short length of follow up.
On December 1, 2020, the Advisory Committee on Immunization Practices (ACIP) voted that, when a COVID-19 vaccine is authorized by the FDA and recommended by ACIP, healthcare personnel should be offered vaccination in the initial phase of the COVID-19 vaccination program (phase 1a) (3) . The healthcare workforce is predominantly female, and women account for 75% of full-time year-round healthcare personnel (4) . ”

“ 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. ”

“ The call center staff will be trained to conduct phone interviews with the pregnant participants, including: confirmation of the identity of the v-safe participant and whether the person was pregnant at the time of vaccination or within 30 days after vaccination, informing the pregnant person about the pregnancy registry, including risks, benefits, and alternatives, requesting consent for participation in the registry and for release of medical records from healthcare providers, and asking specific survey questions relevant to pregnancy. ”

“ 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. ”

“ Persons will be contacted once each trimester during pregnancy and at two time points in the postpartum period, once after delivery and once after the infant is 3 months old. Information collected from the v-safe pregnancy call center survey and medical records will include demographics, pre-pregnancy and gestational conditions, pregnancy history, COVID-19 vaccine information, pregnancy complications, pregnancy outcome and infant outcomes. ”

“ This data will be collected for public health surveillance, not for research purposes. No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare. ”

“ At this postpartum contact, the call center will also request consent from the person for release of her infant’s medical records. A brief, final call center follow up will occur when the infant is 3 months old to inquire about any adverse events, including the diagnosis of any birth defects. ”

“ Females also dominate the largest healthcare occupations, comprising 88% of registered nurses and 86% of healthcare support workers, which includes nursing, psychiatric, and personal and home health aides. ”