The CDC COVID-19 Vaccine Pregnancy Registry (C19VPR) followed 21,378 live-born infants of mothers vaccinated with mRNA or Janssen COVID-19 vaccines (December 2020–June 2021) to assess incidence of low birthweight (LBW), small-for-gestational-age (SGA), infant death, and 10 prespecified conditions (cardiac arrest, cardiomyopathy, hearing loss, heart failure, HIE, intussusception, myocarditis/pericarditis, seizures, stroke, SVT) through 3 months; a subsample (n=9,156) was followed to 15 months.
Among 19,852 infants with 3-month data, 125 (0.6%) had ≥1 prespecified condition. LBW rate was 72.6/1,000 (background: 86/1,000), SGA 71.2/1,000 (background: ~100/1,000), and infant mortality 1.5/1,000 (background: 5.6/1,000 at 0–12 months). Incidence of all 8 conditions with available prepandemic comparators—including HIE (1.0/1,000 vs. 1.7/1,000), seizures (1.8–1.9/1,000 vs. 0.4–3/1,000), hearing loss (1.4–1.7/1,000 vs. 1.8/1,000), and SVT (0.7/1,000 vs. 3/1,000)—were within or below prepandemic ranges. No cases of myocarditis/pericarditis or intussusception were found at 0–3 months.
- No unvaccinated comparison group; rates are compared only to historical prepandemic estimates, many of which are over a decade old. - Convenience sample that is predominantly non-Hispanic White (79.6%) and older (82.3% age ≥30), limiting generalizability. - Relies on maternal self-report; medical record confirmation was obtained for only ~70% of reported cases, with 13% ruled out.
Clinicians counseling pregnant patients can be reassured that, in this large registry of ~20,000 infants, maternal COVID-19 vaccination was not associated with elevated rates of LBW, SGA, infant death, or any of 10 serious infant conditions through 15 months. These data support continuing to offer COVID-19 vaccination during pregnancy.
