Major Birth Defects after Vaccination Reported to the Vaccine Adverse Event Reporting System (VAERS), 1990 to 2014

Moro, Pedro L.; Cragan, Janet D.; Lewis, Paige; Sukumaran, Lakshmi

doi:10.1002/bdr2.23622

Cited by 5 publications

(2 citation statements)

References 25 publications

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“…We screened the KIDS-KD for patients who were listed under the WHO-ART PT 2221 code “exposure during pregnancy” and classified them as pregnant women. 8 The number of AEFIs reported during pregnancy was extremely low, with only 61 vaccine-AE pairs. Five vaccines were reported, as follows: HPV (n=33), DTaP (n=15), herpes zoster (n=10), hepatitis B (n=2), and MMR (n=1).…”

Section: Discussionmentioning

confidence: 99%

“…Meanwhile, although immunization during pregnancy is important to prevent morbidity and mortality during pregnancy and infancy, 7 safety information on vaccination during pregnancy remains insufficient. 8 9 To our knowledge, no studies focusing solely on AEFIs in pregnant women have been conducted in South Korea, and there are no published reports on AEFI surveillance systems for pregnant women. 10 The AEFI studies that have been conducted in South Korea are limited by short study periods, a lack of disproportionality analyses for signal detection, and a lack of information on immunization during pregnancy.…”

Section: Introductionmentioning

confidence: 99%

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Updates on Vaccine Safety and Post-Licensure Surveillance for Adverse Events Following Immunization in South Korea, 2005–2017

et al. 2020

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Purpose: Vaccine hesitancy is among the top ten threats to global health, and access to precise data on adverse events following immunization (AEFIs) is imperative to alleviate public concerns surrounding vaccines. This study aimed to present the overall trends of AEFIs reported in South Korea. Materials and Methods: We evaluated the trends of AEFIs using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System database between January 2005 and December 2017. AEFIs were classified into five categories to evaluate associations between vaccines and AEFIs through a case-non-case study: neurologic reactions, general systemic reactions, local reactions, allergic reactions, and others. Results: Among 54378 reported adverse events (AEs) associated with all vaccines approved in South Korea, more than half (56.7%) occurred following influenza vaccination, followed by the pneumococcal (11.6%) and Bacillus Calmette-Guérin (BCG) vaccines (5.0%). After immunization with most vaccines, general systemic reactions were most common, followed by local and neurologic reactions. Adjusted reporting odds ratios were calculated for all neurologic, general, local, and allergic reactions: of all vaccines, rotavirus [neurologic 2.43, 95% confidence interval (CI), 2.25-2.62], BCG (general; 2.20, 95% CI, 1.91-2.53), BCG (local; 3.15, 95% CI, 2.69-3.68), and Japanese encephalitis (allergic 2.38, 95% CI, 1.98-2.87) vaccines showed the highest values. Conclusion: The majority of reported AEFIs were non-serious and mostly general systemic reactions. Sufficient knowledge on the AEFIs would secure public confidence on the safety of vaccines, thereby reducing public health burden from vaccine-preventable diseases.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Updates on Vaccine Safety and Post-Licensure Surveillance for Adverse Events Following Immunization in South Korea, 2005–2017

et al. 2020

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Safety and Clinical Benefits of Adacel® and Adacel®-Polio Vaccination in Pregnancy: A Structured Literature Review

Clark,

Johnson

2023

Infect Dis Ther

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Vaccination in pregnancy using a tetanus toxoid, reduced dose diphtheria toxoid, and reduced dose acellular pertussis (Tdap) vaccine is important for prevention of severe pertussis disease in young infants. The objectives of this systematic literature review were to search for original research studies evaluating the vaccine effectiveness, immunogenicity, and safety of Adacel ® /Adacel-Polio ® used during pregnancy to prevent pertussis disease in young infants. Medical databases used included EMBASE, BIOSIS Previews, and Chemical Abstracts, with search terms related to pregnancy, vaccines/immunization, safety, pertussis, effectiveness/efficacy, and immune response; other potentially eligible reports were included where applicable. Search results were restricted to literature published from 1 January 1995 to 26 July 2021. A total of 2021 articles and 4 other reports were identified for primary review. A total of 49 publications qualified for inclusion after primary and secondary reviews. Effectiveness studies of Adacel or Adacel-Polio given in pregnancy consistently showed high levels of protection from pertussis disease in the newborn (vaccine effectiveness: 91–93%). In immunogenicity studies, the response in pregnant women was consistent with that of non-pregnant women. Infants of mothers vaccinated with Adacel or Adacel-Polio in pregnancy had higher anti-pertussis antibody levels at birth and at 2 months of age compared to infants born to women vaccinated with comparator vaccines, placebo, or those not vaccinated during pregnancy. There was evidence of a slightly decreased response to primary pertussis vaccination in infants of mothers vaccinated with Adacel or Adacel-Polio, but this was not thought to be clinically significant. In safety studies, Adacel or Adacel-Polio vaccination was well tolerated by pregnant woman and not associated with pregnancy, postpartum, or neonatal complications. In conclusion, Adacel or Adacel-Polio vaccination in pregnancy is highly effective in protecting young infants from pertussis disease, with a favorable safety profile for both pregnant women and their infants.

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Maternal vaccination: a review of current evidence and recommendations

Etti

Calvert

Galiza

et al. 2022

American Journal of Obstetrics and Gynecology

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Maternal vaccination is an effective means of protecting pregnant women, their fetuses, and infants from vaccine-preventable infections. Despite the availability of sufficient safety data to support the use of vaccines during pregnancy, maternal immunization remains an underutilized method of disease prevention, often because of concerns from both healthcare providers and pregnant women about vaccine safety. Such concerns have been reflected in the low uptake of the COVID-19 vaccine among pregnant women seen in many parts of the world. Here, we present an update of the current recommendations for the use of vaccines during pregnancy, including the evidence supporting the use of novel vaccine platforms. We also provide an overview of the data supporting the use of COVID-19 vaccines in pregnancy and an update of the status of vaccines that are currently under development for use in pregnant women.

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Major Birth Defects after Vaccination Reported to the Vaccine Adverse Event Reporting System (VAERS), 1990 to 2014

Cited by 5 publications

References 25 publications

Updates on Vaccine Safety and Post-Licensure Surveillance for Adverse Events Following Immunization in South Korea, 2005–2017

Updates on Vaccine Safety and Post-Licensure Surveillance for Adverse Events Following Immunization in South Korea, 2005–2017

Safety and Clinical Benefits of Adacel® and Adacel®-Polio Vaccination in Pregnancy: A Structured Literature Review

Maternal vaccination: a review of current evidence and recommendations

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