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

v-safe pregnancy registry protocol: March 18, 2021, version 2  V-safe pregnancy surveillance (amendment) 

CDC Investigators and collaborators: Lakshmi Panagiotakopoulos, Titilope Oduyebo, Paige Marquez, Pedro Moro, Christine Olson, Anne Hause, Naomi Tepper, Dana Meaney Delman, Julianne Gee, Tom Shimabukuro, Tanya Myers, Suzanne Gilboa, Sascha Ellington, Shin Kim and others TBD

Protocol amendment summary: V-safe is a novel smartphone-based active vaccine safety surveillance program that will be implemented at the start of an FDA Emergency Use Authorization (EUA) for COVID-19 vaccine use in the United States. As part of this novel public health surveillance activity established for COVID-19, information about pregnancy status at the time of vaccination and at defined follow up time points after vaccination will be collected. This protocol amendment will describe the defined time points and protocol for collecting information about pregnant persons exposed to COVID-19 vaccines and their infants. Given the lack of safety data from preEUA clinical trials of COVID-19 vaccines among pregnant persons, the v-safe pregnancy surveillance system will provide critical information to monitor the safety of COVID-19 vaccines administered under EUA and is intended to capture information about pregnant persons and their infants who have been vaccinated. This can inform clinical guidance regarding COVID-19 vaccination during pregnancy and can provide an additional method to detect adverse events that warrant further evaluation using existing safety and database systems.

Summary of updates:


 * 1) Background was updated to acknowledge there are now three vaccines with FDA EUA.
 * 2) Methods were updated to describe a new three question follow-up survey that will be administered to v-safe participants who report pregnancy.
 * 3) Methods were updated to indicate the v-safe pregnancy registry will now receive full date of birth and race/ethnicity data for participants that may be pregnant from the v-safe survey system
 * 4) Data Collection/Unreachable section (formerly Loss to follow-up) was updated to determine when a participant is considered unreachable.

Background: Pregnancy was an exclusion from enrollment in pre-EUA clinical trials for COVID-19 vaccines ( www.clinicaltrials.gov ). In these pre-EUA clinical trials, pregnancy was screened for and pregnant persons were excluded based on urine pregnancy tests; clinical trial participants were recommended to avoid pregnancy during the trial through the use of reliable and effective contraception. While Pfizer and Moderna vaccine trials did include approximately 36 pregnant persons inadvertently vaccinated during pregnancy, these small numbers are not enough to establish the safety of maternal vaccination (1, 2). 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). 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. Approximately 5% of women of reproductive age are estimated to be pregnant or postpartum at any time, translating to around 330,000 pregnant or newly postpartum women who are healthcare personnel and could be included in phase 1a