Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study

Mascolo, Annamaria; Mauro, Gabriella di; Fraenza, Federica; Gaio, Mario; Zinzi, Alessia; Pentella, Ciro; Rossi, Francesco; Capuano, Annalisa; Sportiello, Liberata

doi:10.3389/fimmu.2022.965171

Cited by 18 publications

(15 citation statements)

References 34 publications

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“…Mascolo et al reviewed 3,592 Case Safety Reports related to COVID-19 injections filed by pregnant women in EudraVigilance during 2021. When the reports related to mRNA injectables were compared to those related to non-mRNA vaccines, the former group showed significantly higher numbers of several unfavorable maternal outcomes (Figure 3; Mascolo et al, 2022).…”

Section: Discussionmentioning

confidence: 99%

“…Eudravigilance is a system operated by the European Medicines Agency (EMA) that manages adverse event reactions to medicines involved in clinical trials in the European Economic Area (EEA). We used data collected in 2021 by Mascolo et al to determine rates of spontaneous abortion, fetal death, stillbirths, and fetal disorders associated with administration of different COVID-19 injectables during pregnancy (Mascolo et al, 2022).…”

Section: Maternal Outcomesmentioning

confidence: 99%

“…Results observed in US data sets are reproducible in international data sets. Mascolo et al reviewed 3,592 Case Safety Reports related to COVID-19 injection filed by pregnant women in EudraVigilance during 2021 (Mascolo et al, 2022). When the reports from pregnant women who received mRNA injectables were compared to those of pregnant women who received non-mRNA injectables, the former experienced nearly ctwelve times as many fetal deaths (0.81% vs. 0.07%); higher rates of stillbirths (0.22% vs. 0.17%); almost nine times as many hemorrhages during pregnancy (0.62% vs. 0.07%); over three times as many fetal disorders (2.5% vs. 0.71%) and congenital anomalies (0.11% vs. 0.03%); almost four times as many premature babies (0.64% vs. 0.17%); and twice as many neonatal deaths (0.06% vs. 0.03%) (Figure 3; (Mascolo et al, 2022).…”

Section: European Datamentioning

confidence: 99%

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Safety of mRNA Vaccines Administered During the First Twenty-Four Months of the International COVID-19 Vaccination Program

Romero¹,

Fry²,

Hooker

2023

Vaccine Theory Prac & Res

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Two mRNA-based COVID vaccines were granted emergency use authorization in both children and adults in 2021 after a drastically accelerated approval process that allowed the manufacturers to essentially fast-track their vaccines. We analyzed data from regulatory surveillance and self-reporting systems like Defense Medical Epidemiology Database(DMED); EudraVigilance; Eurostat; German health insurers; the Israeli Minister of Health; the Natural Cycles app; Public Health Scotland; the United Kingdom’s (UK) Office for National Statistics (ONS); UK’s yellow card reporting system; the vaccine adverse event reporting system (VAERS); and v-safe entries to look for long-term adverse events of these vaccines that cannot be captured in the expedited clinical safety trials. In this observational study, we analyzed non-foreign VAERS data for selected symptoms reported after COVID, influenza, and pertussis vaccines and calculated rates per vaccine dose administered as well as proportion of total reports received. We also looked at DMED data and compared annual incidence rates of selected conditions by taking into account the total number of military personnel for each study year. Our data show, among other trends, increases in adverse event reports if we compare COVID vaccines to influenza and pertussis vaccines and statistically significant higher numbers of hospital encounters in military personnel, as well as increases in incidences of thromboembolic conditions, such as menstrual abnormalities, myocarditis, and cerebrovascular events after the implementation of COVID vaccine mandates, compared to the five years prior. We verified these observations using data from EudraVigilance; the UK’s ONS; German health providers; and Eurostat. Our meta-analysis of both national and international vaccine adverse events emphasizes the importance of re-evaluating public health policies that promote universal mass vaccination and multiple boosters for all demographic groups. In combination with anecdotal evidence, limitations of the safety trials, and the decreased lethality of new strains our research demonstrates that the cost (both monetary and humanitarian) of vaccinating otherwise healthy people, and especially children, may outweigh the benefits.

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Section: Discussionmentioning

confidence: 99%

Section: Maternal Outcomesmentioning

confidence: 99%

Section: European Datamentioning

confidence: 99%

See 1 more Smart Citation

Safety of mRNA Vaccines Administered During the First Twenty-Four Months of the International COVID-19 Vaccination Program

Romero¹,

Fry²,

Hooker

2023

Vaccine Theory Prac & Res

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“…Considering the high risks associated with SARS-CoV-2 infection, the pandemic condition has also imposed the need for pregnant and breastfeeding women to be vaccinated, although there was a lack of evidence from clinical trials. Only later, the data are emerged and are emerging again on the safety of COVID-19 vaccination during pregnancy and breastfeeding (Shimabukuro et al , 2021;Mascolo et al, 2022). Given the stark disparities that arise during COVID-19, the exclusion of pregnant and breastfeeding women from clinical studies as a blanket policy created inequities among populations.…”

Section: Covid-19 Experience: What Do We Learn From It?mentioning

confidence: 99%

It is the time to change the paradigms of pregnant and breastfeeding women in clinical research!

Sportiello

Capuano²

2023

Front. Pharmacol.

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“…From our previous study, PNs emerged as the second nervous subclass of ICI-related neurological complications more frequently described in the European pharmacovigilance database ( 23 ). Therefore, given the wide range of PNs and their impact on patients’ quality of life and the availability of large pharmacovigilance databases ( 24 ), we decided to analyze in more detail the characteristics of ICI related PNs emerging from 10 years of ICI-use in a real-world context.…”

Section: Introductionmentioning

confidence: 99%

Do peripheral neuropathies differ among immune checkpoint inhibitors? Reports from the European post-marketing surveillance database in the past 10 years

et al. 2023

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Although the immunotherapy advent has revolutionized cancer treatment, it, unfortunately, does not spare cancer patients from possible immune-related adverse events (irAEs), which can also involve the peripheral nervous system. Immune checkpoint inhibitors (ICIs), blocking cytotoxic T-lymphocyteassociated protein 4 (CTLA-4), programmed cell death protein 1 (PD-1), or programmed cell death ligand 1 (PD-L1), can induce an immune imbalance and cause different peripheral neuropathies (PNs). Considering the wide range of PNs and their high impact on the safety and quality of life for cancer patients and the availability of large post-marketing surveillance databases, we chose to analyze the characteristics of ICI-related PNs reported as suspected drug reactions from 2010 to 2020 in the European real-world context. We analyzed data collected in the European pharmacovigilance database, Eudravigilance, and conducted a systematic and disproportionality analysis. In our study, we found 735 reports describing 766 PNs occurred in patients treated with ICIs. These PNs included Guillain-Barré syndrome, Miller-Fisher syndrome, neuritis, and chronic inflammatory demyelinating polyradiculoneuropathy. These ADRs were often serious, resulting in patient disability or hospitalization. Moreover, our disproportionality analysis revealed an increased reporting frequency of PNs with tezolizumab compared to other ICIs. Guillain-Barré syndrome is a notable potential PN related to ICIs, as it is associated with a significant impact on patient safety and has had unfavorable outcomes, including a fatal one. Continued monitoring of the safety profile of ICIs in real-life settings is necessary, especially considering the increased frequency of PNs associated with atezolizumab compared with other ICIs.

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Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study

Cited by 18 publications

References 34 publications

Safety of mRNA Vaccines Administered During the First Twenty-Four Months of the International COVID-19 Vaccination Program

Safety of mRNA Vaccines Administered During the First Twenty-Four Months of the International COVID-19 Vaccination Program

It is the time to change the paradigms of pregnant and breastfeeding women in clinical research!

Do peripheral neuropathies differ among immune checkpoint inhibitors? Reports from the European post-marketing surveillance database in the past 10 years

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