2022
DOI: 10.1001/jamapediatrics.2022.0001
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Association of BNT162b2 COVID-19 Vaccination During Pregnancy With Neonatal and Early Infant Outcomes

Abstract: IMPORTANCE Pregnant women were excluded from the BNT162b2 messenger RNA (mRNA) COVID-19 vaccine (Pfizer-BioNTech) preauthorization trial. Therefore, observational data on vaccine safety for prenatally exposed newborns are critical to inform recommendations on maternal immunization. OBJECTIVE To examine whether BNT162b2 mRNA vaccination during pregnancy is associated with adverse neonatal and early infant outcomes among the newborns.DESIGN, SETTING, AND PARTICIPANTS Population-based cohort study comprising all … Show more

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Cited by 120 publications
(204 citation statements)
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“…Sample size ranged from 473 (Siegel et al, 2021) to 355,299 pregnant women (UK Health Security Agency, 2021). Eight studies were cohort studies (Blakeway et al, 2022; Goldshtein et al, 2022; Lipkind et al, 2022; Razzaghi et al, 2021; Rottenstreich et al, 2022; Stock et al, 2022; UK Health Security Agency, 2021; Wainstock et al, 2021) and three studies were cross-sectional (Hosokawa et al, 2022; Siegel et al, 2021; Taubman – Ben=Ari et al, 2022). Two studies used national data (Stock et al, 2022; UK Health Security Agency, 2021), three studies used a convenience sample (Hosokawa et al, 2022; Siegel et al, 2021; Taubman – Ben=Ari et al, 2022), and six studies did not report the sampling method (Blakeway et al, 2022; Goldshtein et al, 2022; Lipkind et al, 2022; Razzaghi et al, 2021; Rottenstreich et al, 2022; Wainstock et al, 2021).…”
Section: Resultsmentioning
confidence: 99%
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“…Sample size ranged from 473 (Siegel et al, 2021) to 355,299 pregnant women (UK Health Security Agency, 2021). Eight studies were cohort studies (Blakeway et al, 2022; Goldshtein et al, 2022; Lipkind et al, 2022; Razzaghi et al, 2021; Rottenstreich et al, 2022; Stock et al, 2022; UK Health Security Agency, 2021; Wainstock et al, 2021) and three studies were cross-sectional (Hosokawa et al, 2022; Siegel et al, 2021; Taubman – Ben=Ari et al, 2022). Two studies used national data (Stock et al, 2022; UK Health Security Agency, 2021), three studies used a convenience sample (Hosokawa et al, 2022; Siegel et al, 2021; Taubman – Ben=Ari et al, 2022), and six studies did not report the sampling method (Blakeway et al, 2022; Goldshtein et al, 2022; Lipkind et al, 2022; Razzaghi et al, 2021; Rottenstreich et al, 2022; Wainstock et al, 2021).…”
Section: Resultsmentioning
confidence: 99%
“…Eight studies were cohort studies (Blakeway et al, 2022; Goldshtein et al, 2022; Lipkind et al, 2022; Razzaghi et al, 2021; Rottenstreich et al, 2022; Stock et al, 2022; UK Health Security Agency, 2021; Wainstock et al, 2021) and three studies were cross-sectional (Hosokawa et al, 2022; Siegel et al, 2021; Taubman – Ben=Ari et al, 2022). Two studies used national data (Stock et al, 2022; UK Health Security Agency, 2021), three studies used a convenience sample (Hosokawa et al, 2022; Siegel et al, 2021; Taubman – Ben=Ari et al, 2022), and six studies did not report the sampling method (Blakeway et al, 2022; Goldshtein et al, 2022; Lipkind et al, 2022; Razzaghi et al, 2021; Rottenstreich et al, 2022; Wainstock et al, 2021). Ten studies were published in peer-reviewed journals (Blakeway et al, 2022; Goldshtein et al, 2022; Hosokawa et al, 2022; Lipkind et al, 2022; Razzaghi et al, 2021; Rottenstreich et al, 2022; Stock et al, 2022; Taubman – Ben=Ari et al, 2022; UK Health Security Agency, 2021; Wainstock et al, 2021) and one study in a pre-print service (Siegel et al, 2021).…”
Section: Resultsmentioning
confidence: 99%
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“…This study contributes to current evidence in establishing the safety of prenatal vaccine exposure to newborns. However, the interpretation of study findings is limited by the observational design ( Goldshtein et al, 2022 ).…”
Section: The Impact Of Coronavirus Disease 2019 Vaccine On Pregnancymentioning
confidence: 99%