在加拿大，妊娠期间接种 COVID-19 疫苗后的反应原性、妊娠结局和 SARS-CoV-2 感染：一项全国性前瞻性队列研究。

Reactogenicity, pregnancy outcomes, and SARS-CoV-2 infection following COVID-19 vaccination during pregnancy in Canada: A national prospective cohort study.

机构信息

Department of Obstetrics & Gynecology, University of British Columbia, Vancouver, Canada.

Women's Health Research Institute, Vancouver, Canada.

出版信息

Vaccine. 2023 Nov 22;41(48):7183-7191. doi: 10.1016/j.vaccine.2023.10.032. Epub 2023 Oct 19.

DOI:10.1016/j.vaccine.2023.10.032

PMID:37865598

Abstract

OBJECTIVE

To describe self-reported reactogenicity, pregnancy outcomes, and SARS-CoV-2 infection following COVID-19 vaccination during pregnancy.

DESIGN

National, prospective cohort study.

SETTING

Participants across Canada were enrolled from July 2021 until June 2022.

POPULATION

Individuals pregnant during the COVID-19 pandemic, regardless of vaccination status, were included.

METHODS

The Canadian COVID-19 Vaccine Registry for Pregnant and Lactating Individuals (COVERED) was advertised through traditional and social media. Surveys were administered at baseline, following each vaccine dose if vaccinated, pregnancy conclusion, and every two months for 14 months. Changes to pregnancy or vaccination status, SARS-CoV-2 infections, or significant health events were recorded.

MAIN OUTCOME MEASURES

Reactogenicity (local and systemic adverse events, and serious adverse events) within 1 week post-vaccination, pregnancy and neonatal outcomes, and subsequent SARS-CoV-2 infection.

RESULTS

Among 2868 participants who received 1-2 doses of a COVID-19 vaccine during pregnancy, adverse events described included: headache (19.5-33.9%), nausea (4.8-13.8%), fever (2.7-10.2%), and myalgia (33.4-42.2%). Reactogenicity was highest after the 2nd dose of vaccine in pregnancy. Compared to 1660 unvaccinated participants, there were no statistically significant differences in adverse pregnancy or infant outcomes, aside from an increased risk of NICU admission ≥ 24 h among the unvaccinated group. During follow-up, there was a higher rate of participant-reported SARS-CoV-2 infection in the unvaccinated compared to the vaccinated group (18[47.4%] vs. 786[27.3%]).

CONCLUSIONS

Participant-reported reactogenicity was similar to reports from non-pregnant adults. There was no increase in adverse pregnancy and birth outcomes among vaccinated vs. unvaccinated participants and lower rates of SARS-CoV-2 infection were reported in vaccinated participants.

TWEETABLE ABSTRACT

No significant increase in adverse pregnancy or infant outcomes among vaccinated versus unvaccinated pregnant women in Canada.

摘要

目的

描述 COVID-19 大流行期间孕妇接种 COVID-19 疫苗后的自述不良反应、妊娠结局和 SARS-CoV-2 感染情况。

设计

全国性前瞻性队列研究。

地点

2021 年 7 月至 2022 年 6 月期间，加拿大各地招募参与者。

人群

包括 COVID-19 大流行期间无论接种疫苗状态如何的孕妇。

方法

通过传统媒体和社交媒体宣传加拿大 COVID-19 疫苗接种妊娠和哺乳期个人登记（COVERED）。在基线时、如果接种疫苗则在每次疫苗接种后、妊娠结束时以及 14 个月内每两个月进行一次调查。记录妊娠或接种疫苗状态的变化、SARS-CoV-2 感染或重大健康事件。

主要观察指标

接种疫苗后 1 周内的不良反应（局部和全身不良反应和严重不良反应）、妊娠和新生儿结局以及随后的 SARS-CoV-2 感染情况。

结果

在 2868 名孕妇中，有 1-2 剂 COVID-19 疫苗接种，描述的不良反应包括：头痛（19.5-33.9%）、恶心（4.8-13.8%）、发热（2.7-10.2%）和肌痛（33.4-42.2%）。在妊娠期间，第二次疫苗接种后的不良反应发生率最高。与 1660 名未接种疫苗的参与者相比，除未接种疫苗组新生儿重症监护病房（NICU）入住时间≥24 小时的风险增加外，不良妊娠或婴儿结局无统计学差异。在随访期间，未接种疫苗组参与者报告的 SARS-CoV-2 感染率高于接种疫苗组（18[47.4%]比 786[27.3%]）。