Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis
- Autores
- Ciapponi, Agustín; Berrueta, Amanda Mabel; P.K. Parker, Edward; Bardach, Ariel Esteban; Mazzoni, Agustina; Anderson, Steven A.; Argento, Fernando J.; Ballivian, Jamile; Bok, Karin; Comandé, Daniel; Goucher, Erin; Kampmann, Beate; Munoz, Flor M.; Rodriguez Cairoli, Federico; Santa María, Victoria; Stergachis, Andy S.; Voss, Gerald; Xiong, Xu; Zamora, Natalia; Zaraa, Sabra; Buekens, Pierre
- Año de publicación
- 2023
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- Background: Assessment of COVID-19 vaccines safety during pregnancy is urgently needed. Methods: We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185). Results: We retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants. A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49–15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56–2.12). Animal studies showed consistent results with studies in pregnant persons. Conclusion: We found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed.
Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Berrueta, Amanda Mabel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: P.K. Parker, Edward. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Bardach, Ariel Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Mazzoni, Agustina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Anderson, Steven A.. US Food & Drug Administration; Estados Unidos
Fil: Argento, Fernando J.. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Ballivian, Jamile. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Bok, Karin. National Institutes of Health; Estados Unidos
Fil: Comandé, Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Goucher, Erin. University of Tulane; Estados Unidos
Fil: Kampmann, Beate. London School of Hygiene and Tropical Medicine; Reino Unido. MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine; Gambia. Universitätsmedizin Charité Berlin; Alemania
Fil: Munoz, Flor M.. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Rodriguez Cairoli, Federico. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Santa María, Victoria. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Stergachis, Andy S.. University of Washington; Estados Unidos
Fil: Voss, Gerald. Coalition for Epidemic Preparedness Innovations; Noruega
Fil: Xiong, Xu. National Institutes of Health; Estados Unidos
Fil: Zamora, Natalia. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Zaraa, Sabra. Texas Children's Hospital Houston; Estados Unidos
Fil: Buekens, Pierre. National Institutes of Health; Estados Unidos - Materia
-
ADJUVANT
COVID-19
META-ANALYSIS
PREGNANCY
SYSTEMATIC REVIEW
VACCINE SAFETY - Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- https://creativecommons.org/licenses/by/2.5/ar/
- Repositorio
.jpg)
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/228775
Ver los metadatos del registro completo
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Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysisCiapponi, AgustínBerrueta, Amanda MabelP.K. Parker, EdwardBardach, Ariel EstebanMazzoni, AgustinaAnderson, Steven A.Argento, Fernando J.Ballivian, JamileBok, KarinComandé, DanielGoucher, ErinKampmann, BeateMunoz, Flor M.Rodriguez Cairoli, FedericoSanta María, VictoriaStergachis, Andy S.Voss, GeraldXiong, XuZamora, NataliaZaraa, SabraBuekens, PierreADJUVANTCOVID-19META-ANALYSISPREGNANCYSYSTEMATIC REVIEWVACCINE SAFETYhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Background: Assessment of COVID-19 vaccines safety during pregnancy is urgently needed. Methods: We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185). Results: We retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants. A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49–15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56–2.12). Animal studies showed consistent results with studies in pregnant persons. Conclusion: We found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed.Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Berrueta, Amanda Mabel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: P.K. Parker, Edward. London School of Hygiene and Tropical Medicine; Reino UnidoFil: Bardach, Ariel Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Mazzoni, Agustina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Anderson, Steven A.. US Food & Drug Administration; Estados UnidosFil: Argento, Fernando J.. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Ballivian, Jamile. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Bok, Karin. National Institutes of Health; Estados UnidosFil: Comandé, Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Goucher, Erin. University of Tulane; Estados UnidosFil: Kampmann, Beate. London School of Hygiene and Tropical Medicine; Reino Unido. MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine; Gambia. Universitätsmedizin Charité Berlin; AlemaniaFil: Munoz, Flor M.. London School of Hygiene and Tropical Medicine; Reino UnidoFil: Rodriguez Cairoli, Federico. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Santa María, Victoria. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Stergachis, Andy S.. University of Washington; Estados UnidosFil: Voss, Gerald. Coalition for Epidemic Preparedness Innovations; NoruegaFil: Xiong, Xu. National Institutes of Health; Estados UnidosFil: Zamora, Natalia. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Zaraa, Sabra. Texas Children's Hospital Houston; Estados UnidosFil: Buekens, Pierre. National Institutes of Health; Estados UnidosElsevier2023-06info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/228775Ciapponi, Agustín; Berrueta, Amanda Mabel; P.K. Parker, Edward; Bardach, Ariel Esteban; Mazzoni, Agustina; et al.; Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis; Elsevier; Vaccine; 41; 25; 6-2023; 3688-37000264-410XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.vaccine.2023.03.038info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S0264410X23003328info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:09:06Zoai:ri.conicet.gov.ar:11336/228775instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-03 10:09:07.198CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse |
| dc.title.none.fl_str_mv |
Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis |
| title |
Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis |
| spellingShingle |
Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis Ciapponi, Agustín ADJUVANT COVID-19 META-ANALYSIS PREGNANCY SYSTEMATIC REVIEW VACCINE SAFETY |
| title_short |
Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis |
| title_full |
Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis |
| title_fullStr |
Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis |
| title_full_unstemmed |
Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis |
| title_sort |
Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis |
| dc.creator.none.fl_str_mv |
Ciapponi, Agustín Berrueta, Amanda Mabel P.K. Parker, Edward Bardach, Ariel Esteban Mazzoni, Agustina Anderson, Steven A. Argento, Fernando J. Ballivian, Jamile Bok, Karin Comandé, Daniel Goucher, Erin Kampmann, Beate Munoz, Flor M. Rodriguez Cairoli, Federico Santa María, Victoria Stergachis, Andy S. Voss, Gerald Xiong, Xu Zamora, Natalia Zaraa, Sabra Buekens, Pierre |
| author |
Ciapponi, Agustín |
| author_facet |
Ciapponi, Agustín Berrueta, Amanda Mabel P.K. Parker, Edward Bardach, Ariel Esteban Mazzoni, Agustina Anderson, Steven A. Argento, Fernando J. Ballivian, Jamile Bok, Karin Comandé, Daniel Goucher, Erin Kampmann, Beate Munoz, Flor M. Rodriguez Cairoli, Federico Santa María, Victoria Stergachis, Andy S. Voss, Gerald Xiong, Xu Zamora, Natalia Zaraa, Sabra Buekens, Pierre |
| author_role |
author |
| author2 |
Berrueta, Amanda Mabel P.K. Parker, Edward Bardach, Ariel Esteban Mazzoni, Agustina Anderson, Steven A. Argento, Fernando J. Ballivian, Jamile Bok, Karin Comandé, Daniel Goucher, Erin Kampmann, Beate Munoz, Flor M. Rodriguez Cairoli, Federico Santa María, Victoria Stergachis, Andy S. Voss, Gerald Xiong, Xu Zamora, Natalia Zaraa, Sabra Buekens, Pierre |
| author2_role |
author author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
ADJUVANT COVID-19 META-ANALYSIS PREGNANCY SYSTEMATIC REVIEW VACCINE SAFETY |
| topic |
ADJUVANT COVID-19 META-ANALYSIS PREGNANCY SYSTEMATIC REVIEW VACCINE SAFETY |
| purl_subject.fl_str_mv |
https://purl.org/becyt/ford/3.3 https://purl.org/becyt/ford/3 |
| dc.description.none.fl_txt_mv |
Background: Assessment of COVID-19 vaccines safety during pregnancy is urgently needed. Methods: We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185). Results: We retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants. A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49–15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56–2.12). Animal studies showed consistent results with studies in pregnant persons. Conclusion: We found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed. Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Berrueta, Amanda Mabel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: P.K. Parker, Edward. London School of Hygiene and Tropical Medicine; Reino Unido Fil: Bardach, Ariel Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Mazzoni, Agustina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Anderson, Steven A.. US Food & Drug Administration; Estados Unidos Fil: Argento, Fernando J.. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Ballivian, Jamile. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Bok, Karin. National Institutes of Health; Estados Unidos Fil: Comandé, Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Goucher, Erin. University of Tulane; Estados Unidos Fil: Kampmann, Beate. London School of Hygiene and Tropical Medicine; Reino Unido. MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine; Gambia. Universitätsmedizin Charité Berlin; Alemania Fil: Munoz, Flor M.. London School of Hygiene and Tropical Medicine; Reino Unido Fil: Rodriguez Cairoli, Federico. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Santa María, Victoria. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Stergachis, Andy S.. University of Washington; Estados Unidos Fil: Voss, Gerald. Coalition for Epidemic Preparedness Innovations; Noruega Fil: Xiong, Xu. National Institutes of Health; Estados Unidos Fil: Zamora, Natalia. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Zaraa, Sabra. Texas Children's Hospital Houston; Estados Unidos Fil: Buekens, Pierre. National Institutes of Health; Estados Unidos |
| description |
Background: Assessment of COVID-19 vaccines safety during pregnancy is urgently needed. Methods: We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185). Results: We retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants. A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49–15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56–2.12). Animal studies showed consistent results with studies in pregnant persons. Conclusion: We found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed. |
| publishDate |
2023 |
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2023-06 |
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article |
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http://hdl.handle.net/11336/228775 Ciapponi, Agustín; Berrueta, Amanda Mabel; P.K. Parker, Edward; Bardach, Ariel Esteban; Mazzoni, Agustina; et al.; Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis; Elsevier; Vaccine; 41; 25; 6-2023; 3688-3700 0264-410X CONICET Digital CONICET |
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Ciapponi, Agustín; Berrueta, Amanda Mabel; P.K. Parker, Edward; Bardach, Ariel Esteban; Mazzoni, Agustina; et al.; Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis; Elsevier; Vaccine; 41; 25; 6-2023; 3688-3700 0264-410X CONICET Digital CONICET |
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eng |
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eng |
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CONICET Digital (CONICET) |
| instname_str |
Consejo Nacional de Investigaciones Científicas y Técnicas |
| repository.name.fl_str_mv |
CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas |
| repository.mail.fl_str_mv |
dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar |
| _version_ |
1842270069825994752 |
| score |
13.13397 |