Influenza vaccination in pregnancy: careful assessment confirms safety concerns for the offspring

Valid evidence does not support universal influenza vaccination for pregnant women, the LTE objections are unfounded. The observational evidence is less valid than that from RCTs: important safety signals in all the RCTs require high consideration. In RCTs, influenza vaccinated women have mostly loc...

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Main Author: Alberto Donzelli
Format: Article
Language:English
Published: Taylor & Francis Group 2019-09-01
Series:Human Vaccines & Immunotherapeutics
Subjects:
Online Access:http://dx.doi.org/10.1080/21645515.2019.1605818
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author Alberto Donzelli
author_facet Alberto Donzelli
author_sort Alberto Donzelli
collection DOAJ
description Valid evidence does not support universal influenza vaccination for pregnant women, the LTE objections are unfounded. The observational evidence is less valid than that from RCTs: important safety signals in all the RCTs require high consideration. In RCTs, influenza vaccinated women have mostly local adverse effects, while their offspring shows a nonsignificant excess of deaths, and a significant excess of serious presumed/neonatal infections in the larger RCT. Several Authors have financial relationships with vaccine producers, several conclusions omit the safety signals. A cited systematic review has methodological problems and excluded important published RCTs. Waiting for new independent RCTs, the precautionary principle suggests avoiding to promote pregnant women vaccination. Health services could offer it highlighting existing uncertainties, with balanced informations allowing informed choices.
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spelling doaj.art-e2daec1bcd274a7e80dfa8529d98e46f2023-09-22T08:45:31ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2019-09-011592168217010.1080/21645515.2019.16058181605818Influenza vaccination in pregnancy: careful assessment confirms safety concerns for the offspringAlberto Donzelli0Fondazione Allineare Sanità e SaluteValid evidence does not support universal influenza vaccination for pregnant women, the LTE objections are unfounded. The observational evidence is less valid than that from RCTs: important safety signals in all the RCTs require high consideration. In RCTs, influenza vaccinated women have mostly local adverse effects, while their offspring shows a nonsignificant excess of deaths, and a significant excess of serious presumed/neonatal infections in the larger RCT. Several Authors have financial relationships with vaccine producers, several conclusions omit the safety signals. A cited systematic review has methodological problems and excluded important published RCTs. Waiting for new independent RCTs, the precautionary principle suggests avoiding to promote pregnant women vaccination. Health services could offer it highlighting existing uncertainties, with balanced informations allowing informed choices.http://dx.doi.org/10.1080/21645515.2019.1605818influenza vaccinationpregnant womenhealthy vaccinee biascochrane systematic reviewserious adverse eventsoffspring deaths
spellingShingle Alberto Donzelli
Influenza vaccination in pregnancy: careful assessment confirms safety concerns for the offspring
Human Vaccines & Immunotherapeutics
influenza vaccination
pregnant women
healthy vaccinee bias
cochrane systematic review
serious adverse events
offspring deaths
title Influenza vaccination in pregnancy: careful assessment confirms safety concerns for the offspring
title_full Influenza vaccination in pregnancy: careful assessment confirms safety concerns for the offspring
title_fullStr Influenza vaccination in pregnancy: careful assessment confirms safety concerns for the offspring
title_full_unstemmed Influenza vaccination in pregnancy: careful assessment confirms safety concerns for the offspring
title_short Influenza vaccination in pregnancy: careful assessment confirms safety concerns for the offspring
title_sort influenza vaccination in pregnancy careful assessment confirms safety concerns for the offspring
topic influenza vaccination
pregnant women
healthy vaccinee bias
cochrane systematic review
serious adverse events
offspring deaths
url http://dx.doi.org/10.1080/21645515.2019.1605818
work_keys_str_mv AT albertodonzelli influenzavaccinationinpregnancycarefulassessmentconfirmssafetyconcernsfortheoffspring