Table 3.
Proportional meta-analysis for uncontrolled studies involving COVID-19 vaccines in pregnant persons.
| Outcomes | Rate associated with mRNA COVID-19# vaccines % (95 CI) | N Studies |
Historical rates | |
|---|---|---|---|---|
| Spontaneous abortion/miscarriage | 4.97 (2.40–8.39) | 5 | 10% (in clinically recognized pregnancies)[98] | |
| Stillbirth | 0.05 (0.00–0.20) | 3 | Finland 2010: 2.9%[110] Belgium 2010: 3.1%[99] UK 2017: 4.2%[100] Argentina, USA 2019: 3.0%[99] Australia 2010: 2.9%[99] Vietnam 2010: 9.6%[99] New Zealand 2010: 3.3%[99] |
|
| Fetal growth retardation | 0.49 (0.34–0.66) | 2 | 23.8% newborns per year[101] | |
| Gestational diabetes | 7.74 (2.31–15.97) | 2 | 6–7%[102] | |
| Hypertensive disorders | 2.37 (0.15–7.17) | 2 | Hypertensive disorders: 10% Preeclampsia: 4–5%[103] |
|
| Small for gestational age | 12.3 (7.31–18.4) | 1 | Asia: 5.3 to 41.5% Africa: 1.2 to 3.0% livebirths[104] |
|
| Preterm birth | 5.61 (2.58–9.72) | 4 | 10%[105] | |
| Maternal death | 0 (0.00–0.03)* | 1 | Israel: 2/100,000 livebirths[106] | |
| Any congenital malformation | 2.32 (1.42–3.44) | 2 | 2–4%[108] | |
| Neonatal death | 0.43 (0.40–3.76) | 1 | Estimations for 2019[107] Argentina: 6% USA: 3.6% Australia: 2.3% UK: 2.7% Finland: 1.4% New Zealand: 2.6% Israel: 1.9% |
|
| Postpartum hemorrhage | 10.40 (6.49–15.10) | 2 | 2–5%[109] | |
| Suspected Chorioamnionitis | 0.19 (0.17–1.63) | 1 | USA: 1–4%[111] | |
| Antenatal bleeding | 0.37 (0.01–1.22) | 1 | 6%[112] | |
| Neonatal infections | 3.24 (2.08–4.65) | 1 | NA | |
| Respiratory distress newborn | 1.82 (1.72–15.31) | 1 | LMICs: 1.2% to 7.2%[113] USA: 10%[114] |
|
| Injection site reactions | LMICs | 58.86 (30.08–84.66) | 4 | – |
| HICs | – | |||
| Fever | 19.28 (0.78–53.55) | 3 | – | |
| Headache | 25.31 (1.95–62.75) | 4 | – | |
| Gastrointestinal | 9.47 (3.33–18.29) | 1 | – | |
| Myalgia | 33.08 (3.51–74.13) | 3 | – | |
| Fatigue | 50.03 (17.52–82.53) | 3 | – | |
| Vomiting | 4.55 (4.19–4.93) | 1 | – | |
| Nausea | 26.61 (25.83–27.39) | 1 | – | |
| Chills | 36.66 (35.81–37.51) | 2 | – | |
| Joint pain | 25.57 (24.80–26.35) | 1 | – | |
MAEs: Medically attended adverse events; SAEs: Serious adverse events; NA: Not available; HICs: High Income Countries; LMICs: Low-to-Middle-Income Countries; #Pfizer/BioNTech and Moderna/NIH (only 0.5% of pregnant persons were exposed to Janssen and Oxford/AstraZeneca vaccines vectored).; *None maternal death the estimated 95% CI is 3.1 to 29.1 / 100,000.