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[Preprint]. 2021 Aug 9:rs.3.rs-798175.
doi: 10.21203/rs.3.rs-798175/v1.

Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020-21

Lauren Head Zauche  1 , Bailey Wallace  1 , Ashley N Smoots  1 , Christine K Olson  1 , Titilope Oduyebo  1 , Shin Y Kim  1 , Emily E Peterson  1 , Jun Ju  1 , Jennifer Beauregard  1 , Allen J Wilcox  2 , Charles E Rose  1 , Dana Meaney-Delman  1 , Sascha R Ellington  1
Affiliations

Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020-21

Lauren Head Zauche et al. Res Sq. .

Abstract

Background: There is continuing public concern about the safety of COVID-19 vaccination during pregnancy. While there is no compelling biological reason to expect that mRNA COVID-19 vaccination (either preconception or during pregnancy) presents a risk to pregnancy, data are limited. It is, however, well documented that SARS-CoV-2 infection during pregnancy is associated with severe illness and increased risk of adverse pregnancy outcomes. Among recognized pregnancies in high-income countries, 11-16% end in spontaneous abortion (SAB).

Methods: People enrolled in v-safe, a voluntary smartphone-based surveillance system, who received a COVID-19 vaccine preconception or during pregnancy were contacted by telephone to enroll in the v-safe pregnancy registry. V-safe pregnancy registry participants who received at least one dose of an mRNA COVID-19 vaccine preconception or prior to 20 weeks' gestation and who did not report a pregnancy loss before 6 completed weeks' gestation were included in this analysis to assess the cumulative risk of SAB using Life Table methods.

Results: Among 2,456 pregnant persons who received an mRNA COVID-19 vaccine preconception or prior to 20 weeks' gestation, the cumulative risk of SAB from 6-19 weeks' gestation was 14.1% (95% CI: 12.1, 16.1%). Using direct age standardization to the selected reference population, the age-standardized cumulative risk of SAB was 12.8% (95% CI: 10.8-14.8%).

Conclusions: When compared to the expected range of SABs in recognized pregnancies, these data suggest receipt of an mRNA COVID-19 vaccine preconception or during pregnancy is not associated with an increased risk of SAB. These findings add to accumulating evidence that mRNA COVID-19 vaccines during pregnancy are safe.

Keywords: COVID-19 vaccine; mRNA vaccine; miscarriage; pregnancy; pregnancy loss; spontaneous abortion; vaccine safety.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Inclusion Criteria: Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020–21
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