Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review
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Abstract
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SciScore for 10.1101/2021.06.03.21258283: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable Case series were included only if they reported on more than 50 exposed pregnant women. Randomization For randomized controlled trials (RCTs), we analyzed the data on an intention□to□treat basis as far as possible (i.e., including all randomized participants in analysis, in the groups to which they were randomized). Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources For this rapid review, we followed the Cochrane methods[10, 11] and the 2020 Preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement[12] for reporting results. Cochranesuggested: (Cochrane Library, RRID:SCR_…SciScore for 10.1101/2021.06.03.21258283: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable Case series were included only if they reported on more than 50 exposed pregnant women. Randomization For randomized controlled trials (RCTs), we analyzed the data on an intention□to□treat basis as far as possible (i.e., including all randomized participants in analysis, in the groups to which they were randomized). Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources For this rapid review, we followed the Cochrane methods[10, 11] and the 2020 Preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement[12] for reporting results. Cochranesuggested: (Cochrane Library, RRID:SCR_013000)We used the 21 standardized case definitions developed by the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) of prioritized obstetric and neonatal outcomes based on the Brighton Collaboration process.[ GAIAsuggested: (GAIA, RRID:SCR_009182)Search strategy: We searched published and unpublished studies without restrictions on language or publication status from inception to February 2021 (See Appendix 1) in the Cochrane Library databases, MEDLINE, EMBASE, Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded (SCI-EXPANDED), China Network Knowledge Information (CNKI), WHO Database of publications on SARS CoV2, TOXLine, pre-print servers (ArXiv, BiorXiv, medRxiv, search.bioPreprint), and COVID-19 research websites (PregCOV-19LSR, Maternal and Child Health, Nutrition: John Hopkins Centre for Humanitarian health, the LOVE database). Cochrane Librarysuggested: (Cochrane Library, RRID:SCR_013000)MEDLINEsuggested: (MEDLINE, RRID:SCR_002185)EMBASEsuggested: (EMBASE, RRID:SCR_001650)ArXivsuggested: (arXiv, RRID:SCR_006500)BiorXivsuggested: (bioRxiv, RRID:SCR_003933)This process was conducted through COVIDENCE,[17] a software for systematic reviews. COVIDENCEsuggested: (Covidence, RRID:SCR_016484)We used the Cochrane EPOC group tools[19] to assess controlled before□after studies (CBAs), nationwide uncontrolled before□after studies (UBAs), interrupted time series (ITSs); Controlled-ITSs (CITSs). Cochrane EPOCsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Our study is not exempt from limitations. Only 11% of the total body of evidence comes from LMICs limiting the generalizability to these settings. Additionally, only 76% of included studies allowed comparisons between vaccinated and unvaccinated pregnant women and only five of them were RCTs. Therefore, most of this evidence is observational. Nevertheless, the absence of safety concerns regardless the study design and publication type suggest that this could not be a major limitation. We are aware that the cut-off of 50 animals for non-human studies could be too high, but allowed us to provide timely answers through a rapid review in the context of the pandemics. Moreover, the set of non-controlled studies do not show unexpected figures with respect to the incidences published in the peer-reviewed literature of neonatal or obstetric outcomes[75]. Regardless of the exposure, all reported a rates of spontaneous abortion in exposed pregnant women described in Table 2 are below the reported the highest global incidence of 31%, or 10% when considering only losses occurring in clinically recognized pregnancies[77]. Tavares 2011 reported a rate of congenital anomalies of 1.9%, in line with the reported rate in the general population of approximately 2 to 4% of livebirths[78-82]. Regarding fetal death, rates reported by Läkemedelsverket 2010 (0.2%) – in Sweden - are consistent with the reported rates of stillbirth for high income countries: approximately 3 deaths per 1000 live births...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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