Monitoring the safety of COVID-19 vaccines in pregnancy in the US

ABSTRACT

Pregnant persons are at increased risk of severe illness from COVID-19. The first COVID-19 vaccines in the U.S. were authorized for emergency use in December 2020 and pregnant persons were eligible and could get vaccinated despite scarce safety data in this population. To monitor the safety of COVID-19 vaccination during pregnancy, four surveillance systems are used by the Centers for Disease Control and Prevention (CDC). The Vaccine Adverse Event Reporting System is a national, passive system that captures reports of potential adverse events. V-safe is a novel, active system that uses text messaging and web-based surveys to provide health check-ins after vaccination; and enrolls eligible v-safe participants in the v-safe pregnancy registry. The Vaccine Safety Datalink is a collaboration between the CDC and nine integrated health care organizations which performs near-real time surveillance and traditional epidemiologic studies on pregnant vaccine recipients. The CDC is committed to timely and comprehensive monitoring of COVID-19 vaccine safety in pregnancy.

KEYWORDS:

• Adverse events
• epidemiology
• coronavirus
• COVID-19
• mRNA vaccines
• SARS-COV-2
• adenovirus type 26
• pregnancy
• surveillance
• vaccine safety

Acknowledgments

We are specially thankful to Michael McNeill, Anne Hause, Christina Banister, and Eric Weintraub for careful review of the manuscript. We also thank the staff of the Immunization Safety Office, General Dynamics Information Technology, Oracle, and all deployers to v-safe and the v-safe pregnancy registry for their work and dedication to public health during the COVID-19 pandemic. We are especially thankful to the participants in all of our vaccine surveillance systems, without whose reports and participation we would be unable to provide timely information on vaccine safety.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Disclaimer

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.