RSV Prefusion F Protein–Based Maternal Vaccine — Preterm Birth and Other Outcomes

New England Journal of Medicine, Год журнала: 2024, Номер 390(11), С. 1009 - 1021

Опубликована: Март 13, 2024

BackgroundVaccination against respiratory syncytial virus (RSV) during pregnancy may protect infants from RSV disease. Efficacy and safety data on a candidate prefusion F protein–based maternal vaccine (RSVPreF3-Mat) are needed.MethodsWe conducted phase 3 trial involving pregnant women 18 to 49 years of age assess the efficacy RSVPreF3-Mat. The were randomly assigned in 2:1 ratio receive RSVPreF3-Mat or placebo between 24 weeks 0 days 34 gestation. primary outcomes any severe medically assessed RSV-associated lower tract disease birth 6 months 12 age. After observation higher risk preterm group than group, enrollment vaccination stopped early, exploratory analyses signal performed.ResultsThe included 5328 5233 infants; target approximately 10,000 their was not reached because early. A total 3426 1711 followed age; 16 infants, respectively, had (vaccine efficacy, 65.5%; 95% credible interval, 37.5 82.0), 8 14, 69.0%; 33.0 87.6). Preterm occurred 6.8% (237 3494) 4.9% those (86 1739) (relative risk, 1.37; confidence interval [CI], 1.08 1.74; P=0.01); neonatal death 0.4% (13 0.2% (3 1739), respectively 2.16; CI, 0.62 7.56; P=0.23), an imbalance probably attributable greater percentage births group. No other observed.ConclusionsThe results this trial, which early concerns, suggest that risks among with but vaccine. (Funded by GlaxoSmithKline Biologicals; ClinicalTrials.gov number, NCT04605159.)

Язык: Английский

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Neonatal Outcomes After COVID-19 Vaccination in Pregnancy

JAMA, Год журнала: 2024, Номер 331(5), С. 396 - 396

Опубликована: Фев. 6, 2024

Importance Better knowledge about neonatal adverse events after COVID-19 vaccination during pregnancy could help address concerns vaccine safety. Objective To evaluate the risks of exposure to pregnancy. Design, Setting, and Participants Population-based cohort study including all infants in Sweden Norway born from June 2021 January 2023. Unique personal identity numbers were used link individual information different national registers. Exposure Administration any mRNA against pregnancy, irrespective previous vaccination, number doses or manufacturer. Main Outcomes Measures conditions with bleeding/thrombosis inflammation/infection; disorders central nervous system; circulatory, respiratory, gastrointestinal problems; mortality. Statistical methods included logistic regression adjusted for characteristics pregnant individuals, additional restricted stratified analyses. Results Of 196 470 newborn (51.3% male, 93.8% at term, 62.5% Sweden), 94 303 (48.0%) exposed Exposed exhibited no increased odds outcomes, they lower nontraumatic intracranial hemorrhage (event rate, 1.7 vs 3.2/1000; ratio [aOR], 0.78 [95% CI, 0.61-0.99]), hypoxic-ischemic encephalopathy (1.8 2.7/1000; aOR, 0.73 0.55-0.96]), mortality (0.9 1.8/1000; 0.68 0.50-0.91]). Subgroup analyses found a similar association between mortality; subgroups delivered by individuals unvaccinated before vaccinated general recommendation was issued, without infection Analyses term infants, singleton births, birth defects yielded results. Stratifying analysis manufacturer did not attenuate low Conclusions Relevance In this large population-based study, vaccines associated their infants.

Язык: Английский

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Preterm Birth Frequency and Associated Outcomes From the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Trial of the Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine

Obstetrics and Gynecology, Год журнала: 2025, Номер unknown

Опубликована: Янв. 2, 2025

OBJECTIVE: To describe preterm birth frequency and newborn infant outcomes overall among children in the MATISSE (Maternal Immunization Study for Safety Efficacy) trial of maternal vaccination with bivalent respiratory syncytial virus (RSV) prefusion F protein–based vaccine (RSVpreF) to protect infants against severe RSV-associated illness. METHODS: was a global, phase 3, randomized, double-blind trial. Pregnant individuals received single injections RSVpreF or placebo. Adverse events special interest, including (gestational age less than 37 weeks) low weight (2,500 g less), were collected through 6 months after delivery (pregnant participants) from 12 24 (pediatric participants). RESULTS: Overall, 7,386 pregnant participants (n=3,698) placebo (n=3,688); 7,305 newborns included analysis. Most both groups born full term (more 93%) normal (95% higher). Newborn outcomes, rates neonatal hospitalization, favorable comparable between groups. Preterm 5.7% arm 4.7% (relative risk [RR] 1.20, 95% CI, 0.98–1.46); most late preterm. Twenty-two deaths occurred during study (RSVpreF n=8, n=14). When stratified by income region, recipients 5.0% high-income countries. Rates non–high-income countries 7.0% 4.0% groups, respectively, 8.3% South Africa (RR 2.06, 1.21–3.51). CONCLUSION: In this vaccination, no clinically significant increase adverse birth, weight, observed people subgroup analysis countries, an elevated observed. More research is needed better ascertain factors, particularly aimed at minimizing disparities geographic regions. FUNDING SOURCE: This sponsored Pfizer. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04424316.

Язык: Английский

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Maternal vaccination against COVID-19 and neonatal outcomes during Omicron: INTERCOVID-2022 study

American Journal of Obstetrics and Gynecology, Год журнала: 2024, Номер 231(4), С. 460.e1 - 460.e17

Опубликована: Фев. 16, 2024

Язык: Английский

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Variability in COVID-19 symptom presentation during pregnancy and its impact on maternal and infant outcomes across the pandemic

International Journal of Infectious Diseases, Год журнала: 2024, Номер 146, С. 107157 - 107157

Опубликована: Июль 5, 2024

Язык: Английский

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Covid-19 infection and vaccination during first trimester and risk of congenital anomalies: Nordic registry based study

BMJ, Год журнала: 2024, Номер unknown, С. e079364 - e079364

Опубликована: Июль 17, 2024

To evaluate the risk of major congenital anomalies according to infection with or vaccination against covid-19 during first trimester pregnancy. Prospective Nordic registry based study. Sweden, Denmark, and Norway. 343 066 liveborn singleton infants in Norway, an estimated start pregnancy between 1 March 2020 14 February 2022, identified using national health registries. Major were categorised EUROCAT (European Surveillance Congenital Anomalies) definitions. The after was assessed by logistic regression, adjusting for maternal age, parity, education, income, country origin, smoking, body mass index, chronic conditions, date 17 704 (5.2%) had a anomaly. When evaluating associated trimester, adjusted odds ratio ranged from 0.84 (95% confidence interval 0.51 1.40) eye 1.12 (0.68 1.84) oro-facial clefts. Similarly, (0.31 2.31) nervous system 1.69 (0.76 3.78) abdominal wall defects. Estimates 10 11 subgroups less than 1.04, indicating no notable increased risk. Covid-19 not anomalies.

Язык: Английский

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Vertical transmission of SARS-CoV-2 – data from the German COVID-19 related obstetric and neonatal outcome study (CRONOS)

Journal of Perinatal Medicine, Год журнала: 2024, Номер 52(2), С. 202 - 209

Опубликована: Янв. 4, 2024

Abstract Objectives We aimed to determine the frequency of SARS-CoV-2 positivity in newborns born mothers with peripartum infection a German cohort, identify potential risk factors associated neonatal infection, and present short-term outcomes vertical transmission SARS-CoV-2. Methods Data on women occurring anytime during their pregnancy was gathered prospectively within CRONOS registry. From April 2020 February 2023 total 8,540 had been registered. The timing probability mother-to-child neonates perinatal were classified using WHO classification system. severity maternal vaccination status, type dominant virus, outcome parameters analyzed as for infection. Results 6.3 % resp. 42.9 tested stillbirths positive. 2.1 confirmed possible identified. Severe COVID-19 (odds ratio 4.4, 95 confidence interval 1.8–11.1) Delta virus (OR 3.2, 1.4–7.7) Newborns or significantly more often admitted NICU (65.2 vs. 27.5 non, p<0.001). Conclusions rate higher our cohort than previously reported, infections rare. Our data emphasizes confirmative testing should be performed infected an underlying pathology leading admission.

Язык: Английский

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Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis

Drug Safety, Год журнала: 2024, Номер 47(10), С. 991 - 1010

Опубликована: Июль 15, 2024

Pregnant persons are susceptible to significant complications following COVID-19, even death. However, worldwide COVID-19 vaccination coverage during pregnancy remains suboptimal.

Язык: Английский

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Perinatal outcomes and sinopharm BBIBP-CorV vaccination during pregnancy

BMC Pregnancy and Childbirth, Год журнала: 2024, Номер 24(1)

Опубликована: Март 11, 2024

Abstract Background After the outbreak of COVID-19, a huge part health care services was dedicated to preventing and treating this disease. In case COVID-19 infection, severe is reported more in pregnant individuals. Afterward, Vaccination against SARS-CoV-2 became hot topic due known effects during pregnancy. individuals started August 2021 with Sinopharm vaccine Iran. The aim current study determine incidence perinatal outcomes women who were vaccinated Method This retrospective cohort included 129,488 singleton births from March 21, 2021, until 2022, Tehran, data obtained Iranian Maternal Neonatal (IMaN) Network Registry. Adverse investigated include preterm birth, extremely low birth weight, very intrauterine growth restriction, stillbirth, neonatal intensive unit admission, congenital anomaly, death 5-minute Apgar score. risk all evaluated using multiple logistic regression. analysis done STATA version 14. Results Of study, 17,485 (13.5%) (all (BBIBP-CorV)). exposure pregnancy caused significant decrease ( P =0.006, OR=0.91 [95% CI, 0.85 0.97]), =<0.001,OR=0.55 0.45 0.66]), stillbirth =<0.001, OR=0.60 0.47 0.76]). Exposure vaccination first trimester associated an increased =0.01, OR=1.27 1.04 1.55]) not other adverse study. Conclusion finding population-based indicated no outcome second third trimesters Overall lower compared unvaccinated group. Also, birth.

Язык: Английский

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Vaccination in pregnancy

Frontiers in Global Women s Health, Год журнала: 2025, Номер 5

Опубликована: Янв. 13, 2025

Citation: Kennedy SH, MacDonald NE and Costa Clemens SA (2025) Vaccination in pregnancy. Front. Glob. Womens Health 5:1523117. doi: 10.3389/fgwh.2024.1523117

Язык: Английский

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