Preliminary safety results for a Covid-19 mRNA vaccine in pregnant women

V-safe monitoring: topical and systemic interaction in pregnant women

Characteristics of people identified as a carrier in the V-safe surveillance system who received the Covid-19 mRNA vaccine. Frequency of local and systemic reactions reported the day after Covid-19 mRNA vaccination in pregnant women.

From December 14, 2020 to February 28, 2021, a total of 35,691 v-safe participants were identified as pregnant. Age distributions were similar between participants who received the Pfizer-BioNTech vaccine and those who received the Moderna vaccine, with the majority of participants ranging in age from 25 to 34 years (61.9% and 60.6% for each vaccine, respectively) and non-Hispanic white (76.2% and 75.4%, respectively); Most of the participants (85.8% and 87.4%, respectively) reported being pregnant at the time of vaccination (Table 1). Requested reports of injection site pain, fatigue, headache, and myalgia were the most common local and systemic reactions following any dose of both vaccines (Table 2) and were reported more frequently after dose 2 for both vaccines. A participant-measured temperature of 38 °C or higher was reported by less than 1% of participants on the first day after dose 1 and by 8.0% after dose 2 for both vaccines.

The most frequent local and systemic reactions reported in the V-safe surveillance system the day after Covid-19 mRNA vaccination.

Required reactions are seen in pregnant and non-pregnant women aged 16-54 who received the coronavirus 2019 (Covid-19) vaccine – BNT162b2 (Pfizer – BioNTech) or mRNA-1273 (Moderna) – as of December 14, 2020, Until February 28, 2021. Calculated percentage of respondents among those who completed the first day survey, with the most significant events occurring at the injection site (pain), fatigue or tiredness (tiredness), headache, muscle or body aches (myalgia), chills Fever, or feel feverish (fever).

These reporting patterns, with respect to both the most frequently reported desired reactions and the higher reporting of the reaction after dose 2, were similar to the patterns observed among non-pregnant women (shape 1). Small differences in frequency of reporting were observed between pregnant and non-pregnant women for specific reactions (injection site pain was reported more frequently among pregnant women, and other systemic reactions were reported more frequently among non-pregnant women), but the overall appearance of the reactions was similar. Pregnant subjects did not report severe reactions more frequently than non-pregnant women, except for nausea and vomiting, which were reported only slightly more frequently after dose 2 (Table S3).

Safe Pregnancy Registry: Pregnancy Outcomes and Newborn Outcomes

Characteristics of participants in the safe pregnancy registry of V.

As of March 30, 2021, the Safe Pregnancy Registry call center attempted to contact 5,230 people vaccinated through February 28, 2021, who were identified during the v-safe survey as being pregnant on or shortly after the Covid-19 vaccination. Of these, 912 were inaccessible, 86 refused to participate, and 274 did not meet the inclusion criteria (for example, were never pregnant, were pregnant, but received the vaccination more than 30 days before their last menstrual period, or did not provide sufficient information to determine eligibility). Enrollment recorded 3958 participants who received the vaccination from 14 December 2020 to 28 February 2021, of whom 3719 (94.0%) were identified as health care workers. Among the enrolled participants, most were 25-44 years old (98.8%), non-Hispanic (79.0%), and, at the time of interview, had not reported a diagnosis of Covid-19 during pregnancy (97.6%) (Table 3). A first dose of vaccine meeting the enrollment criteria was reported to have been received by 92 participants (2.3%) during pregnancy, by 1132 (28.6%) in the first trimester of pregnancy, by 1714 (43.3%) in the second trimester, and by 1019 (25.7%) in the third trimester (one participant lacked information to determine timing of vaccination) (Table 3). Of the 1040 participants (91.9%) who received a vaccine in the first trimester and 1700 (99.2%) who received the vaccine in the second trimester, primary data were collected and scheduled follow-up at specific time points approximately 10 to 12 weeks. ; Limited follow-up calls were made at the time of this analysis.

Pregnancy loss and neonatal outcomes in published studies and participants in the Safe Pregnancy Registry.

Of the 827 participants who completed a pregnancy, pregnancy resulted in a live birth in 712 (86.1%), a spontaneous abortion in 104 (12.6%), a stillbirth in 1 (0.1%), and in other outcomes (induced abortion) and an ectopic pregnancy (in 10) 1.2%). A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation (Table 4), and 700 of 712 pregnancies resulting in a live birth (98.3%) were among subjects who received their first eligible vaccine dose in the third trimester. Adverse outcomes among 724 live infants – including 12 groups from multiple pregnancies – were preterm (60 of 636 among those vaccinated before 37 weeks). [9.4%]), small for gestational age (23 out of 724 [3.2%]), major congenital malformations (16 of 724 .) [2.2%]); No neonatal deaths were reported at the time of the interview. Of the participants who completed pregnancies and who reported birth defects, none had received the Covid-19 vaccine in the first trimester or pregnancy, and no specific pattern of birth defects was observed. The calculated proportions of pregnancy and neonatal outcomes appeared similar to those reported in the peer-reviewed literature (Table 4).

Adverse event outcomes on VAERS

During the analysis period, VAERS received and treated 221 reports of Covid-19 vaccination among pregnant women; 155 (70.1%) included non-pregnancy-specific adverse events, and 66 (29.9%) included pregnancy- or neonatal-specific adverse events (Table S4). The most common pregnancy-related adverse events were spontaneous abortion (46 cases; 37 cases in the first trimester, 2 in the second trimester, and 7 cases in which the trimester was unknown or not reported), followed by stillbirth, and early rupture of membranes , and vaginal bleeding with 3 reports each. No birth defects have been reported to VAERS, which is a requirement under EUAs.

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