Maternal Immunization in Argentina: The Importance of a Safety Profile Analysis

Katz, Nathalia; Neyro, Silvina; Carrega, María Eugenia Pérez; Juárez, María Del Valle; Rancaño, Carolina; Pasinovich, Marina; Aquino, Analía; Vizzotti, Carla

doi:10.1093/ofid/ofw172.598

Cited by 2 publications

(4 citation statements)

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“…A total of 248 studies were excluded, mainly because they did not meet the inclusion criteria of exposure or intervention (119) or insufficient information (74). We included 71 clinical and preclinical studies (72 reports), 61 involving pregnant persons (N= 17,719,495) [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] , [55] , [56] , [57] , [58] , [59] , [60] , [61] , [62] , [63] , [64] , [65] , [66] , [67] , [68] , [69] , [70] , [71] , [72] , [73] , [74] , [75] , [76] , [77] , [78] , [79] , [80] , [81] , [82] , [83] , [84] , [85] , [86] , [87] , [88] , [89] , [90] , and 10 involving pregnant animals (N=389) [91] , ...…”

Section: Resultsmentioning

confidence: 99%

“…Twenty-one (30%) of the included studies reported a relative measure effect comparing vaccinated and unvaccinated pregnant persons. [32] , [33] , [38] , [39] , [45] , [46] , [48] , [50] , [52] , [53] , [54] , [60] , [61] , [66] , [67] , [76] , [79] , [80] , [81] , [82] , [83] Ten out of the 71 studies (14%) were abstracts [41] , [47] , [51] , [55] , [56] , [58] , [73] , [79] , [80] , [82] , and ten were conducted on animals (14%). [91] , [92] , [93] , [94] , [95] , [96] , [97] , [98] , [99] , [100] Only six out of 71 studies (8%) involved low- and middle-income countries (LMICs).…”

Section: Description Of Studiesmentioning

confidence: 99%

See 1 more Smart Citation

Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis

Ciapponi

Berrueta

Parker

et al. 2023

Vaccine

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Section: Resultsmentioning

confidence: 99%

Section: Description Of Studiesmentioning

confidence: 99%

Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis

Ciapponi

Berrueta

Parker

et al. 2023

Vaccine

View full text Add to dashboard Cite

“…The most frequent study location was the USA (n=6), followed by Sweden and United Kingdom (n=5 each), Australia, Canada, and Denmark (n=3 each), Cuba, France and Netherlands (n=2 each), and Argentina, Belgium, Finland, Germany, Norway and multi□country (n=1 each). Only 4 out of 37 studies (11%) involved low-to-middle-income countries (LMICs)[27, 35, 44, 49].…”

Section: Resultsmentioning

confidence: 99%

“…The aluminum phosphate was used in the testing of candidate Respiratory Syncytial Virus Fusion (RSV F) vaccines in pregnant women [28, 44, 48] (n=3). Aluminum phosphate was also used in Tdap vaccines[35, 45, 54] (n=3). Different aluminum salts were used in Hepatitis vaccines[23, 29, 36, 46, 47].…”

Section: Resultsmentioning

confidence: 99%

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

Ciapponi

Bardach

Mazzoni

et al. 2021

Preprint

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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 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) from Pfizer & Moderna 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 in August 2020 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.

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Maternal Immunization in Argentina: The Importance of a Safety Profile Analysis

Cited by 2 publications

References 0 publications

Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis

Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis

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

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