Safety monitoring of bivalent mRNA COVID-19 vaccine among pregnant persons in the vaccine adverse event reporting System - United States, September 1, 2022-March 31, 2023

被引：3

作者：

Moro, Pedro L. ^{[1
]}

Carlock, Grace ^{[1
]}

Fifadara, Nimita ^{[1
]}

Habenicht, Tei ^{[1
]}

Zhang, Bicheng ^{[1
]}

Strid, Penelope ^{[2
]}

Marquez, Paige ^{[1
]}

机构：

[1] Natl Ctr Zoonot & Emerging Infect Dis, Div Healthcare Qual Promot, Immunizat Safety Off, Atlanta, GA 30329 USA

[2] Natl Ctr Zoonot & Emerging Infect Dis, Div Healthcare Qual Promot, Preparedness & Response Branch, Atlanta, GA 30329 USA

来源：

VACCINE | 2024年 / 42卷 / 09期

关键词：

Adverse events; Epidemiology; Coronavirus; COVID-19; mRNA COVID-19 vaccines; Bivalent mRNA COVID-19 vaccine; BA.4/BA.5; strains; SARS-CoV-2; Pregnancy; Surveillance; Vaccine safety;

D O I：

10.1016/j.vaccine.2024.02.084

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background: Pregnant persons are at increased risk of severe COVID-19 illness. Bivalent mRNA COVID-19 vaccination is recommended for everyone, including pregnant persons. However, data are limited on the safety of bivalent mRNA COVID-19 vaccination during pregnancy. Objective: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, among pregnant persons who received bivalent mRNA COVID-19 vaccine. Methods: VAERS U.S. reports of adverse events (AEs) in pregnant persons who received the bivalent mRNA COVID-19 vaccine from 9/1/2022 - 03/31/2023 were identified. Clinicians reviewed all reports and available medical records. AEs of these reports were compared with AEs reported to VAERS following monovalent mRNA COVID-19 booster vaccination in pregnancy. Results: VAERS received 136 reports for pregnant persons who received bivalent mRNA COVID-19 vaccine; 87 (64 %) after BNT162b2 (Pfizer-BioNTech), and 48 (35 %) after mRNA-1273 (Moderna); 28 (20.6 %) reports were classified as serious. The most common pregnancy -specific outcomes reported included 12 (8.8 %) spontaneous abortions ( <20 weeks gestation), 6 (4.4 %) episodes of preterm delivery, and 5 (3.7 %) reports of preeclampsia. One stillbirth ( >= 20 weeks gestation) was reported. No maternal or infant deaths were reported. There were 6 reports of AEs in infants, which included 3 reports of admissions to the neonatal intensive care unit: two infants with low birth weight, and one infant with a patent ductus arteriosus and patent foramen ovale. Non -pregnancyspecific adverse events were mostly COVID-19 infection and systemic reactions (e.g., headache, fatigue). Pregnancy -specific conditions were reported less frequently after bivalent mRNA COVID-19 vaccination compared to monovalent mRNA COVID-19 booster vaccination (3rd and 4th dose). Conclusions: Based on this review of reports to VAERS, the safety profile of bivalent mRNA COVID-19 vaccination in pregnant persons was comparable to that observed for monovalent mRNA COVID-19 booster vaccination (3rd and 4th dose) in pregnant persons.

引用

页码：2380 / 2384

页数：5

共 26 条

[21]

Rosenblum HG, 2022, MMWR-MORBID MORTAL W, V71, P1436, DOI 10.15585/mmwr.mm7145a2

[22]

Rossen LM, 2023, Vital Health Stat, V2, DOI [10.15620/cdc, DOI 10.15620/CDC]

[23] Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons [J].

Shimabukuro, Tom T. ;

Kim, Shin Y. ;

Myers, Tanya R. ;

Moro, Pedro L. ;

Oduyebo, Titilope ;

Panagiotakopoulos, Lakshmi ;

Marquez, Paige L. ;

Olson, Christine K. ;

Liu, Ruiling ;

Chang, Karen T. ;

Ellington, Sascha R. ;

Burkel, Veronica K. ;

Smoots, Ashley N. ;

Green, Caitlin J. ;

Licata, Charles ;

Zhang, Bicheng C. ;

Alimchandani, Meghna ;

Mba-Jonas, Adamma ;

Martin, Stacey W. ;

Gee, Julianne M. ;

Meaney-Delman, Dana M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (24) :2273-2282

[24] Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS) [J].

Shimabukuro, Tom T. ;

Nguyen, Michael ;

Martin, David ;

DeStefano, Frank .

VACCINE, 2015, 33 (36) :4398-4405

[25] Pre-eclampsia [J].

Steegers, Eric A. P. ;

von Dadelszen, Peter ;

Duvekot, Johannes J. ;

Pijnenborg, Robert .

LANCET, 2010, 376 (9741) :631-644

[26]

vaers.hhs, Vaccine Adverse Event Reporting System

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