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Influenza Vaccination of Pregnant Women and Serious Adverse Events in the Offspring.
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- المؤلفون: Donzelli A;Donzelli A
- المصدر:
International journal of environmental research and public health [Int J Environ Res Public Health] 2019 Nov 07; Vol. 16 (22). Date of Electronic Publication: 2019 Nov 07.
- نوع النشر :
Journal Article
- اللغة:
English
- معلومة اضافية
- المصدر:
Publisher: MDPI Country of Publication: Switzerland NLM ID: 101238455 Publication Model: Electronic Cited Medium: Internet ISSN: 1660-4601 (Electronic) Linking ISSN: 16604601 NLM ISO Abbreviation: Int J Environ Res Public Health Subsets: MEDLINE
- بيانات النشر:
Original Publication: Basel : MDPI, c2004-
- الموضوع:
- نبذة مختصرة :
Pregnant women are increasingly considered a priority group for influenza vaccination, but the evidence in favor relies mainly on observational studies, subject to the "healthy-vaccinee bias". Propensity score methods-sometimes applied-reduce but cannot eliminate residual confounding. Meta-analyses of observational studies show relative risks far from the thresholds that would confirm the efficacy of universal vaccination for pregnant women without needing randomized controlled trials (RCTs). Critical articles have shown that in the four RCTs investigating the outcomes of this vaccination, there was a tendency towards higher offspring mortality. In the largest RCT, there was a significant excess of presumed/serious neonatal infections, and also significantly more serious adverse events. Many widely acknowledged observational results (about hormone replacing therapy, vitamin D, omega-3 fatty acids, etc.) were confuted by RCTs. Therefore the international drive to consider this vaccination a "standard of care" is not justified yet. Moreover, there is the risk of precluding further independent RCTs for "ethical considerations", so as "to not deny the benefits of influenza vaccinations to pregnant women of a control group". Instead, before promoting national campaigns for universal vaccination in pregnancy, further large, independent, and reassuring RCTs are needed, even braving challenging a current paradigm. Until then, influenza vaccination should be offered to pregnant women only once open information is available about the safety uncertainties, to allow truly informed choices, and promoting also other protective behaviors.
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- Contributed Indexing:
Keywords: healthy-vaccinee bias; influenza vaccination; informed consent; offspring deaths; pregnant women; real-world vs. randomized evidence; serious adverse events increase
- الرقم المعرف:
0 (Fatty Acids, Omega-3)
0 (Influenza Vaccines)
- الموضوع:
Date Created: 20191110 Date Completed: 20200323 Latest Revision: 20200323
- الموضوع:
20221213
- الرقم المعرف:
PMC6887964
- الرقم المعرف:
10.3390/ijerph16224347
- الرقم المعرف:
31703366
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