Objective: To describe the safety profile and demographic data for a cohort of pregnant individuals who received an mRNA COVID-19 vaccine.
Study Design: Prospective cohort study (with exposure matching) of individuals with active pregnancy who underwent immunization with a novel mRNA COVID-19 vaccine matched 1:2 with vaccinated age-matched female non-pregnant controls. Primary outcome was defined as any vaccine-related complaint as defined in the original safety data. Secondary outcomes included specific complaints, COVID-19 screening test and positive COVID-19 test.
Results: Eighty-three vaccinated pregnant persons were age-matched with 166 female controls, all of whom were vaccinated between December 2020 and January 2021. There was no difference in race or ethnicity between the groups. The mean BMI of pregnant patients was lower than that of controls (26.1 vs 29.2, p=0.002). Frequency of complaint following vaccine administration was not different between pregnant and non-pregnant patients (18.1% vs 16.9%, P=0.201). Pregnant individuals were more likely to report fever (4.8% vs 0.6%, p=0.044) and gastrointestinal symptoms (4.8% vs 0%, p=0.012).
Conclusions: Side effect profiles of Covid 19 vaccine administration at our institution were relatively similar between pregnant and non-pregnant individuals and no serious complications occurred in either group. As COVID-19 infection in pregnancy can have significant morbidity, our data support the continued use of the vaccine for pregnant patients.