Evidence map›Paper›PMID 34489131›Full record

ReviewVaccine2021

Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review.

Agustín Ciapponi, Ariel Bardach, Agustina Mazzoni, Tomás Alconada, Steven A Anderson, Fernando J Argento, Jamile Ballivian, Karin Bok, Daniel Comandé, Emily Erbelding and 15 more

Open access · greenAbstract readReview
In one paragraph

Review in Vaccine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
8.5field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Pooled it
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  6. Review
  7. Article
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  10. Update on Omicron variant and its threat to vulnerable populations.Public health in practice (Oxford, England) · 2024
    Review
  11. Article
  12. Article
  13. Impact of COVID-19 Vaccination on Pregnant Women.Pathogens (Basel, Switzerland) · 2023
    Review
  14. Review
  15. Article
  16. Article
  17. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 11 institutions in 5 countries.

Agustín CiapponiInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina. Electronic address: aciapponi@iecs.org.ar.
Ariel BardachInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina. Electronic address: abardach@iecs.org.ar.
Agustina MazzoniInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina. Electronic address: amazzoni@iecs.org.ar.
Tomás AlconadaInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina.
Steven A AndersonUS Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: Steven.Anderson@fda.hhs.gov.
Fernando J ArgentoInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina. Electronic address: fargento@iecs.org.ar.
Jamile BallivianInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina.
Karin BokNational Institute of Allergy and Infectious Diseases, National Institutes of Health, 31 Center Dr # 7A03, Bethesda, MD 20892, USA. Electronic address: karin.bok@nih.gov.
Daniel ComandéInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina. Electronic address: dcomande@iecs.org.ar.
Emily ErbeldingNational Institute of Allergy and Infectious Diseases, 1 Center Dr # 7A03, Bethesda, USA. Electronic address: emily.erbelding@nih.gov.
Erin GoucherSchool of Public Health and Tropical Medicine, Tulane University, 1440 Canal St, New Orleans, LA 70112, USA. Electronic address: egoucher@tulane.edu.
Beate KampmannThe Vaccine Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK; Vaccines & Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: Beate.Kampmann@lshtm.ac.uk.
Ruth KarronBloomberg School of Public Health, Johns Hopkins University, 7CX5+8W Baltimore, MD, USA. Electronic address: rkarron@jhu.edu.
Flor M MunozBaylor College of Medicine, Texas Children's Hospital, 6621 Fannin St, Houston, TX 77030, USA. Electronic address: florm@bcm.edu.
María Carolina PalermoInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina.
Edward P K ParkerThe Vaccine Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK. Electronic address: Edward.Parker@lshtm.ac.uk.
Federico Rodriguez CairoliInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina. Electronic address: fcairoli@iecs.org.ar.
Victoria Santa MaríaInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina.
Andy S StergachisSchool of Pharmacy and School of Public Health, University of Washington, MM2R+78 Seattle, WA, USA. Electronic address: stergach@uw.edu.
Gerald VossTuBerculosis Vaccine Initiative (TBVI), GHF4+6W Lelystad, the Netherlands. Electronic address: gerald.voss@cepi.net.
Xu XiongSchool of Public Health and Tropical Medicine, Tulane University, 1440 Canal St, New Orleans, LA 70112, USA. Electronic address: xxiong@tulane.edu.
Natalia ZamoraInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina.
Sabra ZaraaSchool of Pharmacy, University of Washington, MM2R+78 Seattle, WA, USA. Electronic address: szaraa@uw.edu.
Mabel BerruetaInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina. Electronic address: mberrueta@iecs.org.ar.
Pierre M BuekensSchool of Public Health and Tropical Medicine, Tulane University, 1440 Canal St, New Orleans, LA 70112, USA. Electronic address: pbuekens@tulane.edu.
Consejo Nacional de Investigaciones Científicas y Técnicas · ARTulane University · USLondon School of Hygiene & Tropical Medicine · GBUniversity of Washington · USBaylor College of Medicine · USInstituto de Efectividad Clínica y Sanitaria · ARJohns Hopkins University · USNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USTuBerculosis Vaccine Initiative · NLUnited States Food and Drug Administration · US

Funding

Medical Research Council MC_PC_17221Medical Research Council MC_UP_A900_1122Medical Research Council MC_UU_00026/2Medical Research Council MR/R005990/1Medical Research Council MR/R005990/2
6 · The paper itself

Abstract

backgroundRapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed.

methodsWe conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185).

resultsWe retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns.

conclusionThis rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.

Indexed as

COVID-19Influenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesAnimalsCOVID-19 VaccinesFemaleHumansPregnancySARS-CoV-2VaccinationCOVID-19 VaccinesInfluenza VaccinesAdjuvantCOVID-19PregnancySystematic reviewVaccine safety

Identifiers

PMID34489131
PMCPMC8360993
OpenAlexW3194662876

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.