Dataset Information

Safety of COVID-19 vaccines, their components or their platforms for pregnant women: A rapid review.

ABSTRACT:

Background

Pregnant women with COVID-19 are at an increased risk of severe COVID-19 illness as well as adverse pregnancy and birth outcomes. Many countries are vaccinating or considering vaccinating pregnant women with limited available data about the safety of this strategy. Early identification of safety concerns of COVID-19 vaccines, including their components, or their technological platforms is therefore urgently needed.

Methods

We conducted a rapid systematic review, as the first phase of an ongoing full systematic review, to evaluate the safety of COVID-19 vaccines in pregnant women, including their components, and their technological platforms (whole virus, protein, viral vector or nucleic acid) used in other vaccines, following the Cochrane methods and the PRISMA statement for reporting (PROSPERO-CRD42021234185).We searched literature databases, COVID-19 and pregnancy registries from inception February 2021 without time or language restriction and explored the reference lists of relevant systematic reviews retrieved. We selected studies of any methodological design that included at least 50 pregnant women or pregnant animals exposed to the vaccines that were selected for review by the COVAX MIWG in August 2020 or their components or platforms included in the COVID-19 vaccines, and evaluated adverse events during pregnancy and the neonatal period.Pairs of reviewers independently selected studies through the COVIDENCE web software and performed the data extraction through a previously piloted online extraction form. Discrepancies were resolved by consensus.

Results

We identified 6768 records, 256 potentially eligible studies were assessed by full-text, and 37 clinical and non-clinical studies (38 reports, involving 2,397,715 pregnant women and 56 pregnant animals) and 12 pregnancy registries were included.Most studies (89%) were conducted in high-income countries. The most frequent study design was cohort studies (n=21), followed by surveillance studies, randomized controlled trials, and registry analyses. Most studies (76%) allowed comparisons between vaccinated and unvaccinated pregnant women (n=25) or animals (n=3) and reported exposures 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), followed by aluminum-based adjuvants (n=11). Aluminum phosphate was used in Respiratory Syncytial Virus Fusion candidate vaccines (n=3) and Tdap vaccines (n=3). Different aluminum-based adjuvants were used in hepatitis vaccines. The replication-deficient simian adenovirus ChAdOx1 was used for a Rift Valley fever vaccine. Only one study reported exposure to messenger RNA (mRNA) COVID-19 vaccines that also used lipid nanoparticles. 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.

Conclusion

This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines that were selected for review by the COVAX MIWG 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 women 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.

SUBMITTER: Ciapponi A

PROVIDER: S-EPMC8202435 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.

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Project description:BackgroundThe development of COVID-19 vaccines has been crucial in fighting the pandemic. However, misinformation about the COVID-19 pandemic and vaccines is spread on social media platforms at a rate that has made the World Health Organization coin the phrase infodemic. False claims about adverse vaccine side effects, such as vaccines being the cause of autism, were already considered a threat to global health before the outbreak of COVID-19.ObjectiveWe aimed to synthesize the existing research on misinformation about COVID-19 vaccines spread on social media platforms and its effects. The secondary aim was to gain insight and gather knowledge about whether misinformation about autism and COVID-19 vaccines is being spread on social media platforms.MethodsWe performed a literature search on September 9, 2021, and searched PubMed, PsycINFO, ERIC, EMBASE, Cochrane Library, and the Cochrane COVID-19 Study Register. We included publications in peer-reviewed journals that fulfilled the following criteria: original empirical studies, studies that assessed social media and misinformation, and studies about COVID-19 vaccines. Thematic analysis was used to identify the patterns (themes) of misinformation. Narrative qualitative synthesis was undertaken with the guidance of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 Statement and the Synthesis Without Meta-analysis reporting guideline. The risk of bias was assessed using the Joanna Briggs Institute Critical Appraisal tool. Ratings of the certainty of evidence were based on recommendations from the Grading of Recommendations Assessment, Development and Evaluation Working Group.ResultsThe search yielded 757 records, with 45 articles selected for this review. We identified 3 main themes of misinformation: medical misinformation, vaccine development, and conspiracies. Twitter was the most studied social media platform, followed by Facebook, YouTube, and Instagram. A vast majority of studies were from industrialized Western countries. We identified 19 studies in which the effect of social media misinformation on vaccine hesitancy was measured or discussed. These studies implied that the misinformation spread on social media had a negative effect on vaccine hesitancy and uptake. Only 1 study contained misinformation about autism as a side effect of COVID-19 vaccines.ConclusionsTo prevent these misconceptions from taking hold, health authorities should openly address and discuss these false claims with both cultural and religious awareness in mind. Our review showed that there is a need to examine the effect of social media misinformation on vaccine hesitancy with a more robust experimental design. Furthermore, this review also demonstrated that more studies are needed from the Global South and on social media platforms other than the major platforms such as Twitter and Facebook.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42021277524; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021277524.International registered report identifier (irrid)RR2-10.31219/osf.io/tyevj.