Page:V-safe Pregnancy Registry Protocol, Version 2.pdf/3

v-safe pregnancy registry protocol: March 18, 2021, version 2 vaccine allocation. Furthermore, on December 20, 2020, the ACIP voted that phase 1c vaccine allocation includes persons aged 16-64 years with medical conditions that increase the risk for severe COVID-19, of which pregnancy is included (5).

Three COVID-19 vaccines have been FDA authorized and ACIP recommended, with permissive language indicating that pregnant women may choose to get any of the vaccines and should discuss risks and benefits with their healthcare providers (6-8). Although it is unknown at this time if FDA will authorize or ACIP will recommend additional COVID-19 vaccines for pregnant or breastfeeding persons, it is important that post-EUA surveillance systems exist to monitor the safety of all COVID-19 vaccines among known and inadvertently vaccinated pregnant persons.

The CDC’s Immunization Safety Office (ISO) will implement multiple systems to monitor the safety of COVID-19 vaccines (9). The Vaccine Adverse Event Reporting System (VAERS) receives passive reports on adverse events following vaccination from the public, medical providers, and manufacturers, and asks specific questions about pregnancy status at the time of vaccination. Pregnancy reports will be abstracted and supplemented with medical records when available. The Vaccine Safety Datalink (VSD) is a collaboration between CDC and nine integrated healthcare systems with demographic, vaccination, and healthcare utilization information on approximately 3% of the US population and 100,000 live births per year. The VSD has an electronic pregnancy episode algorithm that will monitor COVID-19 vaccine coverage and can be used to perform epidemiologic studies on pregnancy loss, acute adverse events, adverse pregnancy outcomes, and infant development and birth defects following exposure to COVID-19 vaccine in pregnancy. The Clinical Immunization Safety Assessment (CISA) project, a collaboration between CDC and seven academic centers, is planning to conduct a clinical trial examining the safety of vaccination during pregnancy. However, given the dearth of safety data of COVID-19 vaccines during pregnancy and the novelty of some COVID-19 vaccine candidate platforms (e.g. mRNA), it is essential that vaccine safety data among pregnant persons is comprehensive and captured in near real-time. A novel smartphone-based active surveillance vaccine safety monitoring system, v-safe, is currently being developed to supplement the ISO’s immunization safety activities. As part of this surveillance activity, information on pregnancy status at the time of vaccination and at subsequent time points will be collected.

CDC plans to use the v-safe system to monitor non-male participants who received COVID-19 vaccines during pregnancy or in the periconception period (30 days before last menstrual period [LMP] through 14 days after LMP) through a pregnancy registry. This surveillance activity will be conducted in order to monitor the safety of COVID-19 vaccines during pregnancy and detect signals of adverse pregnancy and birth outcomes that warrant further investigation.

Objective:

To establish an enhanced active surveillance system for persons exposed to COVID-19 vaccine during pregnancy or in the periconception period to rapidly provide information about the safety of COVID-19 vaccines for pregnant persons and their infants.

Methods:

Surveillance Population and Inclusion Criteria